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Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
NDH
Nail, Fixation, Bone, Metallic
2
Product Code
HRY
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
2
Product Code
HRZ
Prosthesis, Knee, Hinged (Metal-Metal)
3
Product Code
HSA
Prosthesis, Knee, Hemi-, Femoral
3
Product Code
HSB
Rod, Fixation, Intramedullary And Accessories
2
Product Code
NDI
Staple, Fixation, Bone, Metallic
2
Product Code
HRS
Plate, Fixation, Bone
2
Product Code
HSD
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
2
Product Code
HSH
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
2
Product Code
HSN
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
2
Product Code
HSX
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
2
Product Code
HTG
Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
2
Product Code
HTN
Washer, Bolt Nut
2
Product Code
HTY
Pin, Fixation, Smooth
2
Product Code
HWC
Screw, Fixation, Bone
2
Product Code
HXA
Prosthesis, Tendon, Passive
2
Product Code
JDB
Prosthesis, Elbow, Semi-Constrained, Cemented
2
Product Code
JDC
Prosthesis, Elbow, Constrained, Cemented
2
Product Code
JDD
Prosthesis, Upper Femoral
2
Product Code
JDG
Prosthesis, Hip, Femoral Component, Cemented, Metal
2
Product Code
JDH
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
3
Product Code
JDI
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
2
Product Code
K
24
0783
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
2
Cleared 510(K)
K
24
1716
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
2
Cleared 510(K)
K
24
0418
Stryker Orthopaedics Hip Systems Labeling Update
2
Cleared 510(K)
K
23
3261
Global Modular Replacement System
2
Cleared 510(K)
K
22
2056
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
2
Cleared 510(K)
K
22
0216
C-Stem AMT LE Prosthesis
2
Cleared 510(K)
K
21
3701
Exeter® X3® RimFit® Cup
2
Cleared 510(K)
K
21
3816
MPO Hip Instruments
2
Cleared 510(K)
K
21
0842
VerSys Cemented Revision/Calcar
2
Cleared 510(K)
K
20
3815
ELEOS Limb Salvage System with BioGrip
2
Cleared 510(K)
K
20
3588
ELEOS™ Limb Salvage System
2
Cleared 510(K)
K
20
3090
ELEOS Limb Salvage System featuring BIOGRIP
2
Cleared 510(K)
K
20
1519
PROFEMUR® GLADIATOR® Cemented Classic Stem
2
Cleared 510(K)
K
19
3429
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
2
Cleared 510(K)
K
19
1449
ZCA All-Poly Acetabular Cups
2
Cleared 510(K)
K
20
0823
Zimmer, Inc. Hip Joint Prostheses MR Labeling I
2
Cleared 510(K)
K
19
1735
CPT Hip System
2
Cleared 510(K)
K
19
1056
Conformity stem, cemented
2
Cleared 510(K)
K
19
1414
EXETER Centralizer, EXETER 2.5mm Plug
2
Cleared 510(K)
K
18
1340
Cemented TSI Hip Stem
2
Cleared 510(K)
K
18
0973
Libertas Hip Replacement System
2
Cleared 510(K)
K
16
2125
MALUC™ Total Hip Arthroplasty System
2
Cleared 510(K)
K
16
0923
REDAPT Anteverted Cemented Liner
2
Cleared 510(K)
K
15
3057
FitRite™ Total Hip Arthroplasty System
2
Cleared 510(K)
K
15
3725
Corin TaperFit Hip Stem
2
Cleared 510(K)
K
15
3216
Alpine Cemented Hip System
2
Cleared 510(K)
K
15
2621
OSS/Arcos IM Total Femur Rod
2
Cleared 510(K)
K
14
2814
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
2
Cleared 510(K)
K
14
2761
Corin TaperFit Hip Stem
2
Cleared 510(K)
K
14
1331
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
2
Cleared 510(K)
K
14
2295
Sirius Femoral Stem, Size 30A
2
Cleared 510(K)
K
14
1370
RENOVIS CEMENTED HIP SYSTEM
2
Cleared 510(K)
K
13
0610
SIRIUS FEMORAL STEM
2
Cleared 510(K)
K
12
3598
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
2
Cleared 510(K)
K
12
3501
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
2
Cleared 510(K)
K
12
1056
METS MODULAR PROXIMAL FEMUR
2
Cleared 510(K)
K
12
1055
METS MODULAR TOTAL FEMUR
2
Cleared 510(K)
K
11
1863
SIGNATURE PLANNER,SIGNATURE GUIDES
2
Cleared 510(K)
K
12
0578
ACCOLADE II HIP STEM
2
Cleared 510(K)
K
11
1848
EXETER X3 RIMFIT ACETABULAR CUP
2
Cleared 510(K)
K
11
0290
EXETER HIP STEM
2
Cleared 510(K)
K
09
3646
DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
2
Cleared 510(K)
K
09
0998
DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS
2
Cleared 510(K)
K
09
0208
BIOPRO FEMORAL HEADS
2
Cleared 510(K)
K
08
2792
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
2
Cleared 510(K)
K
08
2239
DEPUY C-STEM AMT
2
Cleared 510(K)
K
08
0539
ACCIN UNIPOLAR HEAD SYSTEM
2
Cleared 510(K)
K
08
0885
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
2
Cleared 510(K)
K
07
2857
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT
2
Cleared 510(K)
K
07
0399
100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES
2
Cleared 510(K)
K
07
0364
100KGY E-POLY MAXROM ACETABULAR LINERS
2
Cleared 510(K)
K
06
3278
PORTLAND COBALT CHROME FEMORAL HEAD
2
Cleared 510(K)
K
06
1344
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
2
Cleared 510(K)
K
05
2639
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER
2
Cleared 510(K)
K
05
2748
SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS
2
Cleared 510(K)
K
05
2792
ANTHOLOGY HIP STEM
2
Cleared 510(K)
K
05
1569
RINGLOC BI-POLAR ACETABULAR COMPONENT
2
Cleared 510(K)
K
05
0637
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS
2
Cleared 510(K)
K
05
1407
LEGEND ALL-POLY CUP
2
Cleared 510(K)
K
05
1516
TRABECULAR METAL REVISION SHELL LINERS
2
Cleared 510(K)
K
05
0441
TAPER 2 POROUS FEMORAL STEM
2
Cleared 510(K)
K
05
1363
RESTORATION MODULAR SYSTEM
2
Cleared 510(K)
K
05
1335
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
2
Cleared 510(K)
K
05
0105
NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS
2
Cleared 510(K)
K
05
0138
MODIFICATION TO: RESTORATION MODULAR SYSTEM
2
Cleared 510(K)
K
04
2959
DEPUY C-STEM AMT HIP PROSTHESIS
2
Cleared 510(K)
K
03
3871
IM TOTAL FEMUR
2
Cleared 510(K)
K
03
2730
FIXION HIP SYSTEM
2
Cleared 510(K)
K
03
4028
ATH FEMORAL STEM
2
Cleared 510(K)
K
03
1474
SC TOTAL HIP SYSTEM
2
Cleared 510(K)
K
03
0867
ESKA MODULAR HIP SYSTEM CEMENTED
2
Cleared 510(K)
K
03
1730
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
2
Cleared 510(K)
K
03
2396
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
2
Cleared 510(K)
K
03
1744
OMNIFIT HFX HIP STEM SERIES
2
Cleared 510(K)
K
03
0766
OXINIUM FEMORAL HEADS
2
Cleared 510(K)
K
03
1734
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
2
Cleared 510(K)
K
03
1165
PLUS ORTHOPEDICS CEMENTED HIP STEM
2
Cleared 510(K)
K
03
0153
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
2
Cleared 510(K)
K
03
0265
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
2
Cleared 510(K)
K
02
4340
SMITH & NEPHEW FEMORAL HEADS
2
Cleared 510(K)
K
02
2799
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
2
Cleared 510(K)
K
02
3646
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
2
Cleared 510(K)
K
02
3453
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
2
Cleared 510(K)
K
02
3085
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
2
Cleared 510(K)
K
02
2958
TOTAL HIP FEMORAL HEADS AND LINERS
2
Cleared 510(K)
K
02
2094
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
2
Cleared 510(K)
K
02
2077
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
2
Cleared 510(K)
K
02
1822
R120 MODULAR TOTAL HIP SYSTEM
2
Cleared 510(K)
K
02
1380
OSS LES PROXIMAL FEMORAL COMPONENT
2
Cleared 510(K)
K
02
1310
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
2
Cleared 510(K)
K
02
1178
SL-PLUS LATERALIZED STEM
2
Cleared 510(K)
K
02
0989
SUPER EON PLUS FEMORAL STEMS
2
Cleared 510(K)
K
02
0970
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
2
Cleared 510(K)
K
02
0291
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
2
Cleared 510(K)
K
02
0076
PATRIOT PROTRUSIO CAGE
2
Cleared 510(K)
K
01
1887
AVALON CUP SYSTEM
2
Cleared 510(K)
K
01
3352
SUMMIT CEMENTED HIP PROSTHESIS
2
Cleared 510(K)
K
01
3350
MODIFICATION TO DEPUY C-STEM SYSTEM
2
Cleared 510(K)
K
01
2961
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
2
Cleared 510(K)
K
01
1774
R120 MODULAR TOTAL HIP SYSTEM
2
Cleared 510(K)
K
01
2493
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
2
Cleared 510(K)
K
01
1715
MACROPORE IB RESORBABLE PLUG
2
Cleared 510(K)
K
01
2019
COLOR BUFFED (CB) DDH FEMORAL STEM
2
Cleared 510(K)
K
01
2026
TRIDENT ALL POLY CUP
2
Cleared 510(K)
K
01
1455
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
2
Cleared 510(K)
K
01
1623
EXETER HIP SYSTEM WITH V40 TAPER
2
Cleared 510(K)
K
01
1367
EXCEL FRACTURE CEMENTED HIP STEM
2
Cleared 510(K)
K
01
1218
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
2
Cleared 510(K)
K
01
0529
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
2
Cleared 510(K)
K
01
0757
LFIT V40 FEMORAL HEAD COMPONENTS
2
Cleared 510(K)
K
01
0310
MODIFICATION TO TRIDENT ALL POLY CUP
2
Cleared 510(K)
K
00
3975
BAUMER CEMENTED HIP PROSTHESIS
2
Cleared 510(K)
K
00
3976
BAUMER MULLER HIP PROSTHESIS
2
Cleared 510(K)
K
00
3666
TAPER-FIT TOTAL HIP SYSTEM
2
Cleared 510(K)
K
00
1956
TRIDENT ALL POLY CUP
2
Cleared 510(K)
K
00
3421
DEPUY C-STEM SYSTEM
2
Cleared 510(K)
K
00
2757
ONCOLOGY SALVAGE SYSTEM
2
Cleared 510(K)
K
00
2324
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
2
Cleared 510(K)
K
00
1759
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
2
Cleared 510(K)
K
00
1571
BAUMER FEMORAL HEAD
2
Cleared 510(K)
K
00
2106
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
2
Cleared 510(K)
K
00
1932
TORNIER CEMENT RESTRICTOR
2
Cleared 510(K)
K
00
1376
TI-MAX PROTRUSIO CAGE
2
Cleared 510(K)
K
00
1078
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
2
Cleared 510(K)
K
00
1733
ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES
2
Cleared 510(K)
K
00
0817
OMEGA II MODULAR TOTAL HIP SYSTEM
2
Cleared 510(K)
K
00
1335
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
2
Cleared 510(K)
K
99
0330
CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ
2
Cleared 510(K)
K
00
0254
PAR 5 ACETABULAR COMPONENT
2
Cleared 510(K)
K
99
4007
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
2
Cleared 510(K)
K
99
3713
RIM-FIX, ACETABULAR CUP
2
Cleared 510(K)
K
99
2409
THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ
2
Cleared 510(K)
K
99
2153
PE-PLUS ACETABULAR CUP
2
Cleared 510(K)
K
99
2903
COLOR BUFFED CEMENTED FEMORAL
2
Cleared 510(K)
K
99
2490
B2C HIP SYSTEM
2
Cleared 510(K)
K
99
1869
COBREX HIP STEM, MODEL 01-128-XXXXX
2
Cleared 510(K)
K
99
1622
26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER
2
Cleared 510(K)
K
99
2058
BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
2
Cleared 510(K)
K
99
1987
COLOR BUFFED ANSWER CEMENTED FEMORAL
2
Cleared 510(K)
K
99
1538
OPERA CUPFLANGED ACETABULAR COMPONENTS
2
Cleared 510(K)
K
99
1227
8MM FORGED CEMENTED STEM
2
Cleared 510(K)
K
99
0821
PROVIDENCE CUP SYSTEM
2
Cleared 510(K)
K
98
4227
OMEGA II MODULAR TOTAL HIP SYSTEM
2
Cleared 510(K)
K
99
0369
SYNERGY CEMENTED HIP STEM
2
Cleared 510(K)
K
99
0032
MODULAR PROTUSIO CUP
2
Cleared 510(K)
K
98
4154
APF POROUS COATED LINE EXTENSION
2
Cleared 510(K)
K
98
0926
DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
2
Cleared 510(K)
K
98
0626
DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION
2
Cleared 510(K)
K
98
3226
OSTEONICS X CEMENTED HIP STEM SERIES
2
Cleared 510(K)
K
98
3128
IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY
2
Cleared 510(K)
K
98
3710
150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH
2
Cleared 510(K)
K
98
3136
DEPUY LUSTER STEM
2
Cleared 510(K)
K
98
2963
POLYMER THREADED ANCHOR / SUTURE COMBINATION
2
Cleared 510(K)
K
98
2918
DEPUY C-STEM SYSTEM
2
Cleared 510(K)
K
98
2670
CONTEMPORARY ACETABULAR COMPONENT
2
Cleared 510(K)
K
98
2598
OTI FEMORAL LOCK TOTAL HIP SYSTEM
2
Cleared 510(K)
K
97
4685
OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS
2
Cleared 510(K)
K
98
1855
PRINCE MEDICAL CEMENT PLUG
2
Cleared 510(K)
K
98
0813
RELIANCE LONG STEM FEMORAL COMPONENTS
2
Cleared 510(K)
K
98
0843
EXETER INTRAMEDULLARY BONE PLUG
2
Cleared 510(K)
K
98
0794
DUAL LOCK HIP STEM
2
Cleared 510(K)
K
98
0513
ARTICUL/EZE FEMORAL HEADS
2
Cleared 510(K)
K
98
0486
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
2
Cleared 510(K)
K
98
0286
ULTIMA ACETABULAR ROOF REINFORCEMENT RING
2
Cleared 510(K)
K
97
4558
SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM
2
Cleared 510(K)
K
97
2791
ENCORE LINEAR HIP
2
Cleared 510(K)
K
97
3809
FOUNDATION FRACTURE STEM
2
Cleared 510(K)
K
97
4054
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
2
Cleared 510(K)
K
97
3453
TORNIER CEMENT RESTRICTOR
2
Cleared 510(K)
K
97
1681
SMC FEMORAL HIP COMPONENT
2
Cleared 510(K)
K
97
3296
EXTEND HIP STEM
2
Cleared 510(K)
K
97
2995
THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM
2
Cleared 510(K)
K
97
2961
STELKAST BIPOLAR SYSTEM
2
Cleared 510(K)
K
97
2928
KERBOULL CROSS
2
Cleared 510(K)
K
97
2792
DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
2
Cleared 510(K)
K
97
2641
DUAL OFFSET PERFECTA IMC HIP STEM
2
Cleared 510(K)
K
97
2460
OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)
2
Cleared 510(K)
K
97
2435
ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM
2
Cleared 510(K)
K
97
1890
RECOVERY PROTRUSIO CAGE
2
Cleared 510(K)
K
97
1705
IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED
2
Cleared 510(K)
K
97
1581
HEMISPHERE CEMENTED CUP
2
Cleared 510(K)
K
96
3612
DURATION STABILIZED UHMWPE
2
Cleared 510(K)
K
97
0697
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
2
Cleared 510(K)
K
97
0194
PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT
2
Cleared 510(K)
K
96
5019
THE C-FIT FEMORAL HIP SYSTEM
2
Cleared 510(K)
K
96
4003
METAGEN ALL POLY ACETABULAR CUP SYSTEM
2
Cleared 510(K)
K
97
0351
GLOBAL TAPER SPECTRON HIP STEMS
2
Cleared 510(K)
K
96
4795
CEMENTED CALCAR REPLACEMENT FEMORAL STEM
2
Cleared 510(K)
K
96
4655
UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
2
Cleared 510(K)
K
96
3671
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
2
Cleared 510(K)
K
96
2468
HEDROCEL ACETABULAR RESTRICTOR
2
Cleared 510(K)
K
96
4350
MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA
2
Cleared 510(K)
K
96
3109
HERITAGE HIP SYSTEM
2
Cleared 510(K)
K
96
4218
PERFECTA PLASMA SPRAY HIP STEM
2
Cleared 510(K)
K
96
4262
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
2
Cleared 510(K)
K
96
3486
REVISION HIP SYSTEM
2
Cleared 510(K)
K
96
3313
EXACTECH ALL POLY ACETABULAR CUP
2
Cleared 510(K)
K
96
3206
S-ROM HIP SYSTEM - LOCKING PLUG
2
Cleared 510(K)
K
95
5137
IM C-MENT ACETABULAR CAP
2
Cleared 510(K)
K
96
0425
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
2
Cleared 510(K)
K
96
1304
AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM
2
Cleared 510(K)
K
96
2560
VITALITY HIP STEM
2
Cleared 510(K)
K
96
0984
SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS
2
Cleared 510(K)
K
96
0647
OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS
2
Cleared 510(K)
K
96
2267
PERFECTA PS REVISION STEM
2
Cleared 510(K)
K
96
2086
CPS, CEMENTED CUP SYSTEM
2
Cleared 510(K)
K
96
1899
CPS, CEMENTED HIP SYSTEM
2
Cleared 510(K)
K
96
0278
COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT
2
Cleared 510(K)
K
96
0658
COLLARLESS POLISHED TAPER HIP PROSTHESIS
2
Cleared 510(K)
K
96
1799
NATURAL HIP SYSTEM - DRG HIP STEM
2
Cleared 510(K)
K
96
1619
DEPUY ENDURANCE CALCAR HIP PROSTHESIS
2
Cleared 510(K)
K
96
0258
NATURAL HIP SYSTEM
2
Cleared 510(K)
K
96
1890
FOUNDATION 9MM FORGED CEMENTED STEM
2
Cleared 510(K)
K
96
0025
PROTEK LOW PROFILE ACETABULAR CUP
2
Cleared 510(K)
K
96
0678
BURCH/SCHNEIDER REINFORCEMENT CAGE
2
Cleared 510(K)
K
96
0626
MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)
2
Cleared 510(K)
K
95
4598
OSTEONICS OFFSET HIP STEMS
2
Cleared 510(K)
K
96
0302
CONSENSUS ACETABULAR SHELL, ALL UHMWPE
2
Cleared 510(K)
K
96
0340
CONSENSUS APEX DOME HOLE PLUG
2
Cleared 510(K)
K
96
0339
CONSENSUS 22MM COCRMO FEMORAL HEAD
2
Cleared 510(K)
K
96
0151
CONSENSUS 26MM COCRMO FEMORAL HEAD
2
Cleared 510(K)
K
96
0156
CONSENSUS 32MM COCRMO FEMORAL HEAD
2
Cleared 510(K)
K
95
5620
PRIME CEMENTED CALCAR FEMORAL STEMS
2
Cleared 510(K)
K
95
5473
GAMMA SYSTEM
2
Cleared 510(K)
K
95
5296
LINK MP RECONSTRUCTION HIP
2
Cleared 510(K)
K
95
3200
ULTIMA SIZE 0 CEMENTED FEMORAL STEM
2
Cleared 510(K)
K
95
3202
P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT
2
Cleared 510(K)
K
95
2859
ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT
2
Cleared 510(K)
K
95
5354
ALTERNATIVE STERILIZATION PROCESS
2
Cleared 510(K)
K
95
4744
ZCH ALPHA SYSTEM
2
Cleared 510(K)
K
95
2970
HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM
2
Cleared 510(K)
K
95
2731
TOWNLEY ALL POLY ACETABULAR CUP
2
Cleared 510(K)
K
94
5774
BETA FEMORAL HIP STEM
2
Cleared 510(K)
K
93
5585
APR ACETABULAR INSERTS IOI BIPOLAR
2
Cleared 510(K)
K
95
4219
REALITY LONG STEM HIP SYSTEM
2
Cleared 510(K)
K
95
1139
ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
2
Cleared 510(K)
K
95
4262
NEXUS II FEMORAL COMPONENT
2
Cleared 510(K)
K
95
3578
PROTEK ACETABULAR ROOF REINFORCEMENT RING
2
Cleared 510(K)
K
95
3033
PRIME CEMENTED SMALL FEMORAL STEM
2
Cleared 510(K)
K
95
3025
SLT 28MM XXL FEMORAL HEAD
2
Cleared 510(K)
K
95
2629
NEXFLEX TOTAL HIP SYSTEM
2
Cleared 510(K)
K
93
4857
HSS FEMORAL COMPONENTS
2
Cleared 510(K)
K
95
2191
FORGED CEMENTED STEM
2
Cleared 510(K)
K
93
5263
FOUNDATION POROUS STEM
2
Cleared 510(K)
K
95
2461
ENDO PROSTHESIS FEMORAL HEAD
2
Cleared 510(K)
K
95
1726
S-ROM ZTP UHMWPE ACETABULAR CUP
2
Cleared 510(K)
K
95
0418
ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
2
Cleared 510(K)
K
95
1084
S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS
2
Cleared 510(K)
K
94
5574
OSTEONICS(R) CCR HIP STEM SERIES
2
Cleared 510(K)
K
95
0312
ALPHA SYSTEM
2
Cleared 510(K)
K
94
3696
ALL POLYETHYLENE CEMENTED ACETABULAR CUP
2
Cleared 510(K)
K
95
0761
INDEX ACETABULAT COMPONENT
2
Cleared 510(K)
K
94
5115
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
2
Cleared 510(K)
K
94
4792
ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)
2
Cleared 510(K)
K
94
0328
PRIME CEMENTED HIP SYSTEM
2
Cleared 510(K)
K
94
6371
PROVIDENT HP SYSTEM
2
Cleared 510(K)
K
93
5449
FOUNDATION NON-POROUS STEM
2
Cleared 510(K)
K
94
0307
HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT
2
Cleared 510(K)
K
94
2537
PARAMOUNT CEMENTED HIP STEM PROTHESIS
2
Cleared 510(K)
K
94
3549
RESTORATION ACETABULAR CUP
2
Cleared 510(K)
K
93
0771
PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM
2
Cleared 510(K)
K
94
2370
DEPUY CEMENTED HIP PROSTHESIS
2
Cleared 510(K)
K
93
6127
HOWMEDICA PREMIUM FEMORAL COMPONENT
2
Cleared 510(K)
K
93
6126
HOWMEDICS DRG FEMORAL COMPONENT
2
Cleared 510(K)
K
94
3302
AML TRI-LOCK REPLACEMENT LINER SYSTEM
2
Cleared 510(K)
K
94
2966
AML TRILOCK REPLACEMENT LINER SYSTEM
2
Cleared 510(K)
K
94
1617
APR ACETABULAR INSERT
2
Cleared 510(K)
K
94
2406
OPTION SHELL
2
Cleared 510(K)
K
94
2611
FOUNDATION ALL POLY CUP
2
Cleared 510(K)
K
94
1486
INTEGRITY TOTAL HIP SYSTEM, NON-POROUS
2
Cleared 510(K)
K
93
0275
PRECISION OSTEOLOCK ACETABULAR COMPONENT
2
Cleared 510(K)
K
93
5951
KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM
2
Cleared 510(K)
K
93
5206
KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION
2
Cleared 510(K)
K
93
6214
CS-PLUS STEM
2
Cleared 510(K)
K
93
6132
EXETER ALL PLASTIC ACETABULAR COMPONENT
2
Cleared 510(K)
K
93
2481
SL-PLUS AND SLR-PLUS
2
Cleared 510(K)
K
93
3281
S.O.S. PROXIMAL FEMUR
2
Cleared 510(K)
K
93
6043
FOUNDATION POROUS ACETABULAR COMPONENT
2
Cleared 510(K)
K
93
4169
FOUNDATION ALL POLY CUP
2
Cleared 510(K)
K
93
2574
RMHS POROUS DISTAL SLEEVE
2
Cleared 510(K)
K
93
3561
OSTEONICS OMNIFIT FORGED HIP STEM SERIES
2
Cleared 510(K)
K
93
5012
BIOMETRIC TOTAL HIP SYSTEM
2
Cleared 510(K)
K
93
0187
OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS
2
Cleared 510(K)
K
93
3875
PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE
2
Cleared 510(K)
K
90
3630
PRECISION OSTEOFLEX FEMORAL COMPONENT
2
Cleared 510(K)
K
93
0460
HOWMEDICA REVISION HIP SYSTEM
2
Cleared 510(K)
K
93
0223
HOWMEDICA ACETABULAR SHELL
2
Cleared 510(K)
K
92
6229
APC FEMORAL COMPONENT
2
Cleared 510(K)
K
92
3243
PERFECTA TOTAL HIP SYSTEM
2
Cleared 510(K)
K
93
0812
APR FEMORAL HIP COMPONENT
2
Cleared 510(K)
K
92
5866
CENATOR TOTAL HIP SYSTEM
2
Cleared 510(K)
K
93
0108
RMHS POROUS DISTAL SLEEVE
2
Cleared 510(K)
K
92
5201
EXACTECH FEMORAL STEM
2
Cleared 510(K)
K
92
6323
H-110 ACETABULAR CUP SYSTEM
2
Cleared 510(K)
K
90
5262
BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH
2
Cleared 510(K)
K
92
5348
IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM
2
Cleared 510(K)
K
91
5594
STABILITY HIP FEMORAL COMPONENT
2
Cleared 510(K)
K
92
3275
RMHS MONOLITHIC FEMORAL COMPONENT
2
Cleared 510(K)
K
92
2847
PERFECTA TOTAL HIP SYSTEM
2
Cleared 510(K)
K
91
1058
TECHMEDICA CAD/CAM CUSTOM HIP
2
Cleared 510(K)
K
92
4323
THE UNIVERSAL BONE CEMENT RESISTOR
2
Cleared 510(K)
K
92
2860
AUSTIN-MOORE TYPE HIP PROSTHESIS
2
Cleared 510(K)
K
92
2862
CHARNLEY TYPE HIP PROTHESIS
2
Cleared 510(K)
K
92
2866
OTI BONE PLUG
2
Cleared 510(K)
K
92
2864
MUELLER TYPE FEMORAL STEM
2
Cleared 510(K)
K
92
2863
EUROSTEM HIP PROTHESIS SYSTEM
2
Cleared 510(K)
K
92
2871
UNIFIT FEMORAL STEM
2
Cleared 510(K)
K
92
5895
ETEX HIP REPLACEMENT SYSTEM
2
Cleared 510(K)
K
92
2733
PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP
2
Cleared 510(K)
K
92
2645
LSF ANATOMIC CEMENTED HIP
2
Cleared 510(K)
K
91
4078
DEPUY HIP PROSTHESIS
2
Cleared 510(K)
K
92
4115
ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS
2
Cleared 510(K)
K
92
0739
S-ROM TOTAL HIP REPLACEMENT SYSTEM
2
Cleared 510(K)
K
92
3898
C-FIT CEMENTED HIP STEM
2
Cleared 510(K)
K
91
5500
LESTER PRESS FIT HIP PROSTHESIS
2
Cleared 510(K)
K
92
2421
KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP
2
Cleared 510(K)
K
92
2503
HOWMEDICA(R) HNR SYSTEM
2
Cleared 510(K)
K
91
4675
MODULAR FEMORAL HEAD WITH OFFSET TRUNION
2
Cleared 510(K)
K
92
2008
CDH HIP SYSTEM
2
Cleared 510(K)
K
91
4878
ZIRCONIUM ALLOY FRMORAL HEAD
2
Cleared 510(K)
K
92
0430
MODULAR ACETABULAR CUP SYSTEM
2
Cleared 510(K)
K
92
0639
RX 90 ACETABULAR COMPONENT SYSTEM
2
Cleared 510(K)
K
92
0640
FULL HEMISPHERE RING-LOC LINER
2
Cleared 510(K)
K
92
1383
PRECISION STRATA TOTAL HIP STEM
2
Cleared 510(K)
K
92
0286
DEPUY TOTAL HIP BALLS - ION IMPLANTATION
2
Cleared 510(K)
K
92
0250
OSTEONICS MICROSURFACED CDH HIP STEM
2
Cleared 510(K)
K
92
0161
BIOMET NTS FEMORAL COMPONENTS
2
Cleared 510(K)
K
92
0021
LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
2
Cleared 510(K)
K
92
0317
S-ROM LF FEMORAL HEAD
2
Cleared 510(K)
K
92
0003
DRG CEMETED STEM
2
Cleared 510(K)
K
91
5795
PERFECTA PDA TOTAL HIP SYSTEM
2
Cleared 510(K)
K
91
5216
SOLUTION SYSTEM CUP
2
Cleared 510(K)
K
91
1802
PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP
2
Cleared 510(K)
K
91
4406
PT II DISTAL CEMENT SPACER
2
Cleared 510(K)
K
91
3231
S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD
2
Cleared 510(K)
K
91
2712
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS
2
Cleared 510(K)
K
91
3634
APR II HIP SYSTEM
2
Cleared 510(K)
K
91
3874
INFINITY(TM) MICROTAPER HIP SYSTEM
2
Cleared 510(K)
K
91
3812
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES
2
Cleared 510(K)
K
91
3649
MODULAR CALCAR REPLACEMENT
2
Cleared 510(K)
K
91
3616
LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP
2
Cleared 510(K)
K
91
3246
HYBRID FIT TOTAL HIP SYSTEM
2
Cleared 510(K)
K
91
3208
APR II NON-POROUS HIP STEM
2
Cleared 510(K)
K
91
3060
NATURAL POROUS HIP SYSTEM
2
Cleared 510(K)
K
91
2593
MODULAR HIP SYSTEM
2
Cleared 510(K)
K
91
2916
APR COLLAR SPACER
2
Cleared 510(K)
K
91
2426
UHMWP ACETABULAR COMPONENT
2
Cleared 510(K)
K
91
1890
OSTEONICS(R) PRT HIP STEM SERIES
2
Cleared 510(K)
K
90
4737
GROSS HIP FEMORAL COMPONENT
2
Cleared 510(K)
K
91
1718
M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST)
2
Cleared 510(K)
K
91
1685
RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP
2
Cleared 510(K)
K
91
0093
FUTURA FEMORAL HIP STEM
2
Cleared 510(K)
K
91
1684
BIOMET COBALT-CHROME FEMORAL COMPONENTS
2
Cleared 510(K)
K
91
1052
NEXUS(TM) FEMORAL HIP STEM
2
Cleared 510(K)
K
90
5298
TITAN TOTAL HIP DEVICE
2
Cleared 510(K)
K
91
0836
LIMA COLLARED CL STEM
2
Cleared 510(K)
K
91
0352
BIOPRO METAL BACKED CEMENTED ACETABULAR CUP
2
Cleared 510(K)
K
91
0869
HOWMEDICA(R) CEMETED FEMORAL COMPONENT
2
Cleared 510(K)
K
90
5258
S-ROM OBLONG ACETABULAR CUP
2
Cleared 510(K)
K
91
0662
PS OMNIFIT NORMALIZED HIP STEM SERIES
2
Cleared 510(K)
K
91
0922
OSTEONICS CDH HIP STEM
2
Cleared 510(K)
K
91
0988
OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES
2
Cleared 510(K)
K
90
5408
NEXUS ACETABULAR CUP
2
Cleared 510(K)
K
90
5275
OSTEONICS(R) MPSS HIP STEM SERIES
2
Cleared 510(K)
K
90
5406
OSTEONICS HIP REVISION WEDGES
2
Cleared 510(K)
K
90
5158
OSTEONICS(R) 6011 HIP STEM SERIES
2
Cleared 510(K)
K
90
4207
BIOPRO TRINITY ACETABULAR CUP
2
Cleared 510(K)
K
90
3938
C FIT CUP
2
Cleared 510(K)
K
89
6851
PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC
2
Cleared 510(K)
K
90
4919
PROXIMAL FEMUR REPLACEMENT STEM
2
Cleared 510(K)
K
90
4844
PRECISION HIP STEM WITH ADDITIONAL STEM SIZES
2
Cleared 510(K)
K
90
3957
VSP HIP STEM
2
Cleared 510(K)
K
90
3635
PERFECTA TOTAL HIP SYSTEM
2
Cleared 510(K)
K
90
3636
OSTEONICS DRM ACETABULAR COMPONENT
2
Cleared 510(K)
K
90
3116
RM ISOELASTIC BEVELLED ACETABULAR CUP
2
Cleared 510(K)
K
90
3362
OSTEOLOCK(TM) ACETABULAR CUP
2
Cleared 510(K)
K
90
4351
FOCUS COBALT CHROMIUM TOTAL HIP
2
Cleared 510(K)
K
90
3234
F-19 TOTAL HIP PROSTHESIS
2
Cleared 510(K)
K
90
2961
DIMENSION-II TOTAL HIP SYSTEM
2
Cleared 510(K)
K
90
0261
ACSYS PREFIX ACETABULAR CUP PROSTHESIS
2
Cleared 510(K)
K
90
2621
SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT
2
Cleared 510(K)
K
90
1451
F-20 CEMENTED METAL-BACKED ACETABULAR CUP
2
Cleared 510(K)
K
90
2436
HG MULTILOCK HIP PROSTHESIS W/TINIDIUM SURFACE
2
Cleared 510(K)
K
90
2395
MODIFIED AML + ACETABULAR CUP SYSTEM
2
Cleared 510(K)
K
90
2396
MODIFIED DEPUY ACETABULAR CUP SYSTEM
2
Cleared 510(K)
K
90
2727
LSF CEMENTED FEMORAL HIP
2
Cleared 510(K)
K
90
2279
KM-5 METAL BACKED ACETABULAR CUP
2
Cleared 510(K)
K
90
3243
MULLER-TYPE FEMORAL COMPONENT
2
Cleared 510(K)
K
90
3242
ACETABULAR CUP
2
Cleared 510(K)
K
90
2137
P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT
2
Cleared 510(K)
K
90
1480
F-20 TOTAL HIP PROSTHESIS
2
Cleared 510(K)
K
90
1460
LSF(TM) TOTAL HIP SYSTEM
2
Cleared 510(K)
K
90
1328
DOMED AND FINNED ACETABULAR COMPONENT
2
Cleared 510(K)
K
90
1364
HGP II TOTAL HIP FEMERAL STEM
2
Cleared 510(K)
K
90
1087
MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS
2
Cleared 510(K)
K
90
0832
MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.
2
Cleared 510(K)
K
90
1297
EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP
2
Cleared 510(K)
K
90
0438
MC2P ACETABULAR COMPONENT
2
Cleared 510(K)
K
90
0257
MULLER TYPE ACETABULAR CUP
2
Cleared 510(K)
K
90
1240
ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED
2
Cleared 510(K)
K
90
0836
OSTEONICS ECSI HIP STEM SERIES
2
Cleared 510(K)
K
90
0891
MODIFIED AML + ACETABULAR CUP PROSTHESIS
2
Cleared 510(K)
K
89
5036
TITANIUM MODULAR MODULAR COLLARLESS HIP
2
Cleared 510(K)
K
89
5035
TITANIUM MODULAR COLLARED HIP PROSTHESIS
2
Cleared 510(K)
K
89
6325
QUANTUM HIP STEM
2
Cleared 510(K)
K
89
5636
DIMENSION REVISION TOTAL HIP SYSTEM
2
Cleared 510(K)
K
88
4890
LORD L.F.R. TOTAL HIP SYSTEM
2
Cleared 510(K)
K
89
3821
ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.
2
Cleared 510(K)
K
89
0498
FREEMAN MODULAR HIP STEM RIDGED VERSION
2
Cleared 510(K)
K
89
4298
MODIFIED GEMINI ACETABULAR CUP
2
Cleared 510(K)
K
89
4149
MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL
2
Cleared 510(K)
K
89
4148
MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL
2
Cleared 510(K)
K
89
4249
UNIVERSAL CEMENTED CUP
2
Cleared 510(K)
K
88
5192
APR COLLARED REVISION FEMORAL COMPONENT
2
Cleared 510(K)
K
89
1454
EXETER II TOTAL HIP SYSTEM
2
Cleared 510(K)
K
89
0742
INTRAFORM TOTAL HIP SYSTEM
2
Cleared 510(K)
K
88
4027
PERFECTA II/NON-COATED TOTAL HIP SYSTEM
2
Cleared 510(K)
K
88
5338
AML BOWED FEMORAL HIP
2
Cleared 510(K)
K
89
0649
OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST.
2
Cleared 510(K)
K
89
0054
M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.
2
Cleared 510(K)
K
88
4888
MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS
2
Cleared 510(K)
K
88
3618
PERFECTA II TOTAL HIP SYSTEM
2
Cleared 510(K)
K
88
4432
MODIFIED LSF TOTAL HIP SYSTEM
2
Cleared 510(K)
K
88
3941
PROFORMA HIP SYSTEM
2
Cleared 510(K)
K
88
4457
MODULAR COLLARED HJD TOTAL HIP SYSTEM
2
Cleared 510(K)
K
88
3724
GEMINI FEMORAL HIP PROSTHESIS
2
Cleared 510(K)
K
88
2869
TOWNLEY COX COMB ACETABULAR COMPONENT
2
Cleared 510(K)
K
88
3460
FOCUS TOTAL HIP SYSTEM
2
Cleared 510(K)
K
88
2146
BIOPRO PC FEMORAL HIP COMPONENT
2
Cleared 510(K)
K
88
2812
OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM
2
Cleared 510(K)
K
88
0435
PROFORMA/PS TOTAL HIP SYSTEM
2
Cleared 510(K)
K
88
1769
HJD CALCAR REPLACEMENT PROSTHESIS
2
Cleared 510(K)
K
88
0269
LCS FEMORAL HIP PROSTHESIS
2
Cleared 510(K)
K
88
1117
RESUBMITTING OF HJD TOTAL HIP SYSTEM
2
Cleared 510(K)
K
87
1867
ELITE MODULAR HIP SYSTEM
2
Cleared 510(K)
K
88
0390
INTRAFORM TOTAL HIP SYSTEM
2
Cleared 510(K)
K
88
1128
TITANIUM FEMORAL HIP
2
Cleared 510(K)
K
88
0461
PERFECTA TOTAL HIP SYSTEM
2
Cleared 510(K)
K
88
0004
TOWNLEY COX COMB ACETABULAR CUP
2
Cleared 510(K)
K
87
1852
COXA ACETABULAR CUP
2
Cleared 510(K)
K
87
4619
SPECTRON EF ACETABULAR COMPONENT
2
Cleared 510(K)
K
87
4599
MOORE HIP PROSTHESIS SOLID STEM
2
Cleared 510(K)
K
87
4616
MOORE HIP PROSTHESIS FENESTRATED STEM
2
Cleared 510(K)
K
87
4093
SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP
2
Cleared 510(K)
K
87
3626
FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM
2
Cleared 510(K)
K
87
3632
HI-NEK TOTAL HIP
2
Cleared 510(K)
K
87
3857
WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS
2
Cleared 510(K)
K
87
4229
ANATOMIC TOTAL HIP
2
Cleared 510(K)
K
87
3999
PREMIER-TOTAL (TM) HIP
2
Cleared 510(K)
K
87
3585
POROUS COATED ACETABULAR CUP
2
Cleared 510(K)
K
87
0922
C.L.E. ACETABULAR CUP
2
Cleared 510(K)
K
87
2732
MCCUTCHEN ACETABULAR CUP PROSTHESIS
2
Cleared 510(K)
K
86
4999
KENNEDY STEM
2
Cleared 510(K)
K
87
2856
BIOPRO 32MM BALL
2
Cleared 510(K)
K
87
1402
MURRAY/WELCH TOTAL HIP SYSTEM
2
Cleared 510(K)
K
87
1347
WAGNER REVISIONAL FEMORAL HIP PROSTHESIS
2
Cleared 510(K)
K
87
1857
HPS II CALCAR FEMORAL PROSTHESIS
2
Cleared 510(K)
K
87
1462
PROSTHETIC - FEMORAL HIP COMPONENT
2
Cleared 510(K)
K
87
0235
OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
2
Cleared 510(K)
K
87
1401
KIRSCHNER MODULAR HIP SYSTEM
2
Cleared 510(K)
K
87
0128
HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)
2
Cleared 510(K)
K
87
0699
STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP
2
Cleared 510(K)
K
87
1299
SDI TOTAL HIP SYSTEM
2
Cleared 510(K)
K
86
4857
OPTI-FIX ACETABULAR COMPONENT
2
Cleared 510(K)
K
87
0445
THREADED ACETABULAR COMPONENT
2
Cleared 510(K)
K
87
0216
MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS
2
Cleared 510(K)
K
86
1988
MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
2
Cleared 510(K)
K
86
3184
PROFILE HIP ACETABULUM PROSTHESIS
2
Cleared 510(K)
K
86
1979
AML II TITANIUM ACETABULUM PROSTHESIS
2
Cleared 510(K)
K
86
1433
UNIVERSAL ACETABULAR COMPONENT
2
Cleared 510(K)
K
86
2234
EXACTECH TOTAL HIP SYSTEM
2
Cleared 510(K)
K
86
2225
INTERNATIONAL TOTAL HIP SYSTEM
2
Cleared 510(K)
K
86
1930
CM-6 TOTAL HIP SYSTEM
2
Cleared 510(K)
K
85
5017
LSF* TOTAL HIP SYSTEM
2
Cleared 510(K)
K
86
1114
MALLORY/HEAD - PF ACETABULAR COMPONENT
2
Cleared 510(K)
K
86
0002
CONICAL COLLAR HIP PROSTHESIS POROUS COATED
2
Cleared 510(K)
K
85
5200
MODULAR PRESS FIT (MPF) STEM
2
Cleared 510(K)
K
86
0701
HPS II SMOOTH STEM
2
Cleared 510(K)
K
85
4465
LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM
2
Cleared 510(K)
K
85
3916
P.M. HIP-FEMORAL PROSTHESIS
2
Cleared 510(K)
K
84
4050
ARTHOPOR-ACETABULAR COMPONENT
2
Cleared 510(K)
K
85
3886
P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM
2
Cleared 510(K)
K
85
4046
CONICAL COLLAR HIP PROSTHESIS
2
Cleared 510(K)
K
85
3768
MULLER SELF LOCKING TOTAL HIP
2
Cleared 510(K)
K
85
3408
COLLAR LESS AML HIP
2
Cleared 510(K)
K
85
3169
GT HIP PROSTHESIS FEMORAL COMPONENT
2
Cleared 510(K)
K
85
2839
FREEMAN HIP
2
Cleared 510(K)
K
85
3655
NEW JERSEY MODULAR FEMORAL HIP
2
Cleared 510(K)
K
84
4319
KM-2 METAL-BACKED ACETABULAR CUP
2
Cleared 510(K)
K
85
2517
CLS HIP PROSTHESIS
2
Cleared 510(K)
K
85
1422
S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP
2
Cleared 510(K)
K
85
2585
POROUS APF/MODULAR FEMORAL COMPONENT
2
Cleared 510(K)
K
85
2546
HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY
2
Cleared 510(K)
K
85
2153
THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP
2
Cleared 510(K)
K
85
2705
LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS
2
Cleared 510(K)
K
84
4787
BIOMETRIC TOTAL HIP SYSTEM
2
Cleared 510(K)
K
84
4817
MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM
2
Cleared 510(K)
K
84
4941
CFE ACETABULAR CUP
2
Cleared 510(K)
K
84
5005
BROOKER ACETABULAR CUP
2
Cleared 510(K)
K
84
4028
LORD SCREW RING ACETABULAR COMPONENT
2
Cleared 510(K)
K
84
3190
HAP ACETABULAR CUP
2
Cleared 510(K)
K
84
3909
TITANIUM HIP 1019
2
Cleared 510(K)
K
84
2360
DORR HIP PROSTHESIS FEMORAL COMPONENT
2
Cleared 510(K)
K
84
2906
BIAS TOTAL HIP
2
Cleared 510(K)
K
84
2202
NEW JERSEY ACETABULAR COMPONENT &
2
Cleared 510(K)
K
83
4035
UNIVERSAL SELF-ALIGNING ACETABULAR COM
2
Cleared 510(K)
K
84
0643
HARRIS-GALANTE POROUS TOTAL HIP SYS
2
Cleared 510(K)
K
84
1391
WEBER-STUHMER HIP PROSTHESIS STEM
2
Cleared 510(K)
K
84
0150
TOTAL HIP FEMORAL COMPONENT
2
Cleared 510(K)
K
84
0357
SSA HIP PROSTHESIS
2
Cleared 510(K)
K
83
3881
ACETABULAR SCREW RING
2
Cleared 510(K)
K
83
3912
GALANTE FIBER METAL TOTAL HIP
2
Cleared 510(K)
K
83
2958
FREEMAN ACETABULAR CUP
2
Cleared 510(K)
K
83
2211
DOSIMETRIC RELEASE OF GAMMA RADIATION
2
Cleared 510(K)
K
83
0361
MMS ACETABULAR CUPS
2
Cleared 510(K)
K
83
1884
SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL
2
Cleared 510(K)
K
83
1373
P.C.A. HIP SYSTEM
2
Cleared 510(K)
K
83
1986
METAL-BACKED ACE TABULAR CUP
2
Cleared 510(K)
K
83
1314
INTERFERENCE MEDULLARY FIT -IMF-HIP
2
Cleared 510(K)
K
83
0948
WEBER/STIIHMER FEMORAL HEAD PROSTHESIS
2
Cleared 510(K)
K
83
0314
MILWAUKEE AUSTIN MOORE TOTAL HIP
2
Cleared 510(K)
K
83
0313
CFE TOTAL HIP FEMORAL COMPONENT
2
Cleared 510(K)
K
83
0209
LUS ACETABULAR COMPONENT
2
Cleared 510(K)
K
83
0857
HARRIS A.R. C. ACETABULAR CUP
2
Cleared 510(K)
K
83
0750
CEMENTED 101 32 FEMORAL COMPONENT
2
Cleared 510(K)
K
83
0004
POROCOAT DUAL-LOCK TOTAL HIP SYSTEM
2
Cleared 510(K)
K
83
0356
TITANIUM M.E. MULLER TYPE TOTAL HIP
2
Cleared 510(K)
K
82
3723
SPECTRON PROXIMAL FEMORAL PROSTHESIS
2
Cleared 510(K)
K
82
3724
SPECTRON NECK REPLACEMENT PROSTHESIS
2
Cleared 510(K)
K
82
3727
SPECTRON PRIMARY STEM FEMORAL PROSTHES
2
Cleared 510(K)
K
82
3722
SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
2
Cleared 510(K)
K
82
3725
SPECTRON PROTRUSIO CUP
2
Cleared 510(K)
K
82
3729
SPECTRON METAL BACK ACETABULAR COMPONENT
2
Cleared 510(K)
K
82
3728
SPECTRON POLYETHYLENE ACCTUBULAR COMPON
2
Cleared 510(K)
K
82
3419
HC 1M METALBACKED ACETABULAR CUP
2
Cleared 510(K)
K
82
2979
CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES
2
Cleared 510(K)
K
82
1893
ZIMMER METAL BACKED ACETABULAR CUP
2
Cleared 510(K)
K
82
1714
POROCOAT STANDARD METAL BACKED CUP
2
Cleared 510(K)
K
82
1713
POROCOAT LOW PROFILE METAL BACKED CUP
2
Cleared 510(K)
K
82
1369
TITANIUM AUFRANC-TURNER ATS HIP SYS
2
Cleared 510(K)
K
82
1066
CONTOUR II LINK SP TOTAL HIP PROSTHESIS
2
Cleared 510(K)
K
81
3600
AUFRANC-TURNER TYPE ACETABULAR COMPON
2
Cleared 510(K)
K
81
3089
CEMENT RING
2
Cleared 510(K)
K
81
2801
HIP STEM SYSTEM TITANIUM ALLOY
2
Cleared 510(K)
K
80
2342
PROXIMAL INTERPHALANGEAL JOINT IMPLANT
2
Cleared 510(K)
K
81
2182
MIAMI, PROTRUSIO RING
2
Cleared 510(K)
K
81
1293
EFTEKHAR CENTRALIZING PLUG
2
Cleared 510(K)
K
81
1151
COLLARLESS TOTAL HIP FEMORAL COMP. SYS
2
Cleared 510(K)
K
80
3126
EXETER TOTAL HIP SYSTEM
2
Cleared 510(K)
K
81
0120
REINFORCED HIP CUP
2
Cleared 510(K)
K
80
3074
FERNORAL HIP PROSTHESIS
2
Cleared 510(K)
K
80
2627
ORTRON 90* HIP PROSTHESIS
2
Cleared 510(K)
K
80
2872
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
2
Cleared 510(K)
K
80
0487
3M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM
2
Cleared 510(K)
K
79
0488
INTERPLANTA SP TOTAL HIP PROSTHESIS
2
Cleared 510(K)
K
78
0398
CUP, ACETABULAR, LONG POSTERIOR WALL
2
Cleared 510(K)
K
78
0317
TOTAL HIP SYSTEM, HARRIS HD2
2
Cleared 510(K)
K
78
0052
PROSTHESIS, DOUBLE CUP
2
Cleared 510(K)
K
77
0908
PROSTHESIS, HIP, TRAPEZOIDAL-28
2
Cleared 510(K)
JDL
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
3
Product Code
JDN
Implant, Fixation Device, Spinal
2
Product Code
JDO
Device, Fixation, Proximal Femoral, Implant
2
Product Code
JDP
Condylar Plate Fixation Implant
2
Product Code
JDQ
Cerclage, Fixation
2
Product Code
JDR
Staple, Fixation, Bone
2
Product Code
JDS
Nail, Fixation, Bone
2
Product Code
JDT
Cap, Bone
1
Product Code
JDW
Pin, Fixation, Threaded
2
Product Code
JEC
Component, Traction, Invasive
2
Product Code
JWH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
2
Product Code
JWI
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
2
Product Code
JWJ
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
2
Product Code
KIG
Prosthesis, Wrist, Constrained, Polymer
2
Product Code
KMB
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
2
Product Code
KMC
Prosthesis, Hip, Semi-Constrained, Composite/Metal
2
Product Code
KMD
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite
2
Product Code
KRN
Metal Cemented Constrained Femorotibial Knee Prosthesis
3
Product Code
KRO
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
2
Product Code
KRP
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
3
Product Code
KRQ
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
2
Product Code
KRR
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
2
Product Code
KRS
Prosthesis, Knee, Hemi-, Femoral (Uncemented)
3
Product Code
KTT
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
2
Product Code
KTW
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
2
Product Code
KTX
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
2
Product Code
KWA
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
3
Product Code
KWB
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
3
Product Code
KWD
Prosthesis, Toe, Hemi-, Phalangeal
2
Product Code
KWE
Prosthesis, Finger, Constrained, Metal, Uncemented
3
Product Code
KWF
Prosthesis, Finger, Polymer
2
Product Code
KWG
Prosthesis, Finger, Constrained, Metal/Polymer
3
Product Code
KWH
Prosthesis, Toe, Constrained, Polymer
2
Product Code
KWI
Prosthesis, Elbow, Hemi-, Radial, Polymer
2
Product Code
KWJ
Prosthesis, Elbow, Hemi-, Humeral, Metal
3
Product Code
KWK
Appliance, Nail/Blade/Plate Combination, Single Component
2
Product Code
KWL
Prosthesis, Hip, Hemi-, Femoral, Metal
2
Product Code
KWM
Prosthesis, Wrist, Semi-Constrained
2
Product Code
KWN
Prosthesis, Wrist, Carpal Lunate
2
Product Code
KWO
Prosthesis, Wrist, Carpal Scaphoid
2
Product Code
KWP
Appliance, Fixation, Spinal Interlaminal
2
Product Code
KWQ
Appliance, Fixation, Spinal Intervertebral Body
2
Product Code
KWR
Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
3
Product Code
KWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
2
Product Code
KWT
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
2
Product Code
KWY
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
2
Product Code
KWZ
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
2
Product Code
KXA
Prosthesis, Hip, Femoral, Resurfacing
2
Product Code
KXB
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer
3
Product Code
KXC
Prosthesis, Ankle, Cemented, Non-Constrained
3
Product Code
KXD
Prosthesis, Hip, Constrained, Metal
3
Product Code
KXE
Prosthesis, Wrist, Hemi-, Ulnar
2
Product Code
KYI
Prosthesis, Wrist, Carpal Trapezium
2
Product Code
KYJ
Prosthesis, Finger, Constrained, Polymer
2
Product Code
KYK
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
2
Product Code
KYM
Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
3
Product Code
KYN
Prosthesis, Wrist, Constrained, Metal
3
Product Code
LBC
Prosthesis, Finger, Constrained, Metal, Cemented
3
Product Code
LGE
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
2
Product Code
LOD
Bone Cement
2
Product Code
LPH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
2
Product Code
LRN
Wire, Surgical
2
Product Code
LTO
Spacer, Cement
3
Product Code
LWJ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
2
Product Code
LXT
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
2
Product Code
LYP
Accessories, Fixation, Spinal Interlaminal
2
Product Code
LYT
Fixation Accessory
2
Product Code
LZO
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
2
Product Code
LZY
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
2
Product Code
MAI
Fastener, Fixation, Biodegradable, Soft Tissue
2
Product Code
MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
2
Product Code
MAY
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
2
Product Code
MBB
Bone Cement, Antibiotic
2
Product Code
MBF
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
2
Product Code
MBH
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
2
Product Code
MBI
Fastener, Fixation, Nondegradable, Soft Tissue
2
Product Code
MBL
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
2
Product Code
MBP
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
2
Product Code
MBV
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
2
Product Code
MEH
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
2
Product Code
MJW
Prosthesis, Subtalar, Plug, Polymer
2
Product Code
MNH
Orthosis, Spondylolisthesis Spinal Fixation
2
Product Code
MNI
Orthosis, Spinal Pedicle Fixation
2
Product Code
MNU
Staple, Absorbable
2
Product Code
MQP
Spinal Vertebral Body Replacement Device
2
Product Code
MQV
Filler, Bone Void, Calcium Compound
2
Product Code
MRY
Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component
2
Product Code
NDD
Cerclage, Fixation, Metallic
2
Product Code
NDE
Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
2
Product Code
NDF
Plate, Fixation, Bone, Non-Spinal, Metallic
2
Product Code
NDG
Washer, Bolt, Nut, Non-Spinal, Metallic
2
Product Code
NDJ
Screw, Fixation, Bone, Non-Spinal, Metallic
2
Product Code
NDK
System, External Fixator (With Metallic Invasive Components)
2
Product Code
NDL
Pin, Fixation, Smooth, Metallic
2
Product Code
NDM
Pin, Fixation, Threaded, Metallic
2
Product Code
NDN
Cement, Bone, Vertebroplasty
2
Product Code
NJA
Accessory, System, External Fixator, Containing Antimicrobial Agent
2
Product Code
NJD
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
2
Product Code
NKB
Thoracolumbosacral Pedicle Screw System
2
Product Code
NKG
Posterior Cervical Screw System
2
Product Code
NOV
Anchor, Suture, Bone Fixation, Metallic
2
Product Code
NPJ
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
2
Product Code
NQP
Posterior Metal/Polymer Spinal System, Fusion
2
Product Code
NQW
Orthosis, Spine, Plate, Laminoplasty, Metal
2
Product Code
NUD
Vertebroplasty Compound, Calcium Based
2
Product Code
NVC
Bone, Heterograft
3
Product Code
NWN
Laparoscopic Bone Anchor Urethropexy Instrument Kit
2
Product Code
OBL
Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
2
Product Code
OBM
Cement, Bone, Vertebroplasty, Pre-Formed, Modular
2
Product Code
OBT
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
2
Product Code
OCG
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
3
Product Code
ODP
Intervertebral Fusion Device With Bone Graft, Cervical
2
Product Code
OIS
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
2
Product Code
OIY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
2
Product Code
OJB
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
2
Product Code
OJM
Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
2
Product Code
OOG
Knee Arthroplasty Implantation System
2
Product Code
OOL
Electronic Depth Gauge
2
Product Code
OQB
Intervertebral Body Graft Containment Device
2
Product Code
OQG
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
2
Product Code
OQH
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
2
Product Code
OQI
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
2
Product Code
OSH
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
2
Product Code
OSN
Software For Diagnosis/Treatment
2
Product Code
OUR
Sacroiliac Joint Fixation
2
Product Code
OVD
Intervertebral Fusion Device With Integrated Fixation, Lumbar
2
Product Code
OVE
Intervertebral Fusion Device With Integrated Fixation, Cervical
2
Product Code
OVZ
Pin, Fixation, Resorbable, Hard Tissue
2
Product Code
OWI
Bone Fixation Cerclage, Sublaminar
2
Product Code
OYK
Ankle Arthroplasty Implantation System
2
Product Code
OZI
Internal Hinged Elbow Fixator
2
Product Code
PAO
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
2
Product Code
PBF
Orthopaedic Surgical Planning And Instrument Guides
2
Product Code
PBI
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
2
Product Code
PEK
Spinous Process Plate
2
Product Code
PHM
Intervertebral Fusion Device With Bone Graft, Thoracic
2
Product Code
PHQ
Anterior Staple As Supplemental Fixation For Fusion
2
Product Code
PHX
Shoulder Prosthesis, Reverse Configuration
2
Product Code
PKC
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
2
Product Code
PLF
Bone Wedge
2
Product Code
PLR
Spinal Vertebral Body Replacement Device - Cervical
2
Product Code
PLW
Acetabular Cup Orientation System
2
Product Code
PML
Bone Cement, Posterior Screw Augmentation
2
Product Code
PPQ
Transtibial Anterior Cruciate Ligament Kit
2
Product Code
QHQ
Total Shoulder Arthroplasty System
2
Product Code
PQC
Pedicle Screw Placement Guide
2
Product Code
QAC
Screw Sleeve Bone Fixation Device
2
Product Code
QAD
Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
2
Product Code
QFP
Intraoperative Orthopedic Strain Sensor
2
Product Code
QHE
Shoulder Arthroplasty Implantation System
2
Product Code
QNI
Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
2
Product Code
QPP
Implantable Post-Surgical Kinematic Measurement Knee Device
2
Product Code
QPQ
Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
2
Product Code
JDJ
Mesh, Surgical, Acetabular, Hip, Prosthesis
2
Product Code
JDK
Prosthesis, Hip, Cement Restrictor
2
Product Code
LZN
Cement Obturator
2
Product Code
OLC
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
2
Product Code
QSD
Posterior Cervical Screw Placement Guide
2
Product Code
QSR
Sacroiliac Screw Placement Guide
2
Product Code
QVI
Screw Sleeve Bone Fixation Device, Spine
2
Product Code
QUW
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
2
Product Code
QWJ
Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
2
Product Code
SAI
Ankle Fusion Cage
2
Product Code
SCY
Sacroiliac Joint Guidewire Placement Device
2
Product Code
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Pathology
Review Panel
Physical Medicine
Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 9 May 2025 at 11:05 pm
OR
/
subpart-d—prosthetic-devices
/
JDI
/
K010757
View Source
LFIT V40 FEMORAL HEAD COMPONENTS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K010757
510(k) Type
Special
Applicant
HOWMEDICA OSTEONICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/11/2001
Days to Decision
29 days
Submission Type
Summary
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Miscellaneous
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
NDH
Nail, Fixation, Bone, Metallic
HRY
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
HRZ
Prosthesis, Knee, Hinged (Metal-Metal)
HSA
Prosthesis, Knee, Hemi-, Femoral
HSB
Rod, Fixation, Intramedullary And Accessories
NDI
Staple, Fixation, Bone, Metallic
HRS
Plate, Fixation, Bone
HSD
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
HSH
Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)
HSN
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
HSX
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
HTG
Prosthesis, Knee, Hemi-, Patellar Resurfacing, Uncemented
HTN
Washer, Bolt Nut
HTY
Pin, Fixation, Smooth
HWC
Screw, Fixation, Bone
HXA
Prosthesis, Tendon, Passive
JDB
Prosthesis, Elbow, Semi-Constrained, Cemented
JDC
Prosthesis, Elbow, Constrained, Cemented
JDD
Prosthesis, Upper Femoral
JDG
Prosthesis, Hip, Femoral Component, Cemented, Metal
JDH
Prosthesis, Hip, Hemi-, Trunnion-Bearing, Femoral, Metal/Polyacetal
JDI
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
K
24
0783
Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip Stems
K
24
1716
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component
K
24
0418
Stryker Orthopaedics Hip Systems Labeling Update
K
23
3261
Global Modular Replacement System
K
22
2056
Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee
K
22
0216
C-Stem AMT LE Prosthesis
K
21
3701
Exeter® X3® RimFit® Cup
K
21
3816
MPO Hip Instruments
K
21
0842
VerSys Cemented Revision/Calcar
K
20
3815
ELEOS Limb Salvage System with BioGrip
K
20
3588
ELEOS™ Limb Salvage System
K
20
3090
ELEOS Limb Salvage System featuring BIOGRIP
K
20
1519
PROFEMUR® GLADIATOR® Cemented Classic Stem
K
19
3429
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
K
19
1449
ZCA All-Poly Acetabular Cups
K
20
0823
Zimmer, Inc. Hip Joint Prostheses MR Labeling I
K
19
1735
CPT Hip System
K
19
1056
Conformity stem, cemented
K
19
1414
EXETER Centralizer, EXETER 2.5mm Plug
K
18
1340
Cemented TSI Hip Stem
K
18
0973
Libertas Hip Replacement System
K
16
2125
MALUC™ Total Hip Arthroplasty System
K
16
0923
REDAPT Anteverted Cemented Liner
K
15
3057
FitRite™ Total Hip Arthroplasty System
K
15
3725
Corin TaperFit Hip Stem
K
15
3216
Alpine Cemented Hip System
K
15
2621
OSS/Arcos IM Total Femur Rod
K
14
2814
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial
K
14
2761
Corin TaperFit Hip Stem
K
14
1331
BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS)
K
14
2295
Sirius Femoral Stem, Size 30A
K
14
1370
RENOVIS CEMENTED HIP SYSTEM
K
13
0610
SIRIUS FEMORAL STEM
K
12
3598
SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION
K
12
3501
OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS
K
12
1056
METS MODULAR PROXIMAL FEMUR
K
12
1055
METS MODULAR TOTAL FEMUR
K
11
1863
SIGNATURE PLANNER,SIGNATURE GUIDES
K
12
0578
ACCOLADE II HIP STEM
K
11
1848
EXETER X3 RIMFIT ACETABULAR CUP
K
11
0290
EXETER HIP STEM
K
09
3646
DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS
K
09
0998
DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS
K
09
0208
BIOPRO FEMORAL HEADS
K
08
2792
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS
K
08
2239
DEPUY C-STEM AMT
K
08
0539
ACCIN UNIPOLAR HEAD SYSTEM
K
08
0885
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION
K
07
2857
TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT
K
07
0399
100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES
K
07
0364
100KGY E-POLY MAXROM ACETABULAR LINERS
K
06
3278
PORTLAND COBALT CHROME FEMORAL HEAD
K
06
1344
EXCIA TOTAL HIP SYSTEM LATERAL OFFSET
K
05
2639
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER
K
05
2748
SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS
K
05
2792
ANTHOLOGY HIP STEM
K
05
1569
RINGLOC BI-POLAR ACETABULAR COMPONENT
K
05
0637
ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS
K
05
1407
LEGEND ALL-POLY CUP
K
05
1516
TRABECULAR METAL REVISION SHELL LINERS
K
05
0441
TAPER 2 POROUS FEMORAL STEM
K
05
1363
RESTORATION MODULAR SYSTEM
K
05
1335
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
K
05
0105
NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS
K
05
0138
MODIFICATION TO: RESTORATION MODULAR SYSTEM
K
04
2959
DEPUY C-STEM AMT HIP PROSTHESIS
K
03
3871
IM TOTAL FEMUR
K
03
2730
FIXION HIP SYSTEM
K
03
4028
ATH FEMORAL STEM
K
03
1474
SC TOTAL HIP SYSTEM
K
03
0867
ESKA MODULAR HIP SYSTEM CEMENTED
K
03
1730
36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS
K
03
2396
RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS
K
03
1744
OMNIFIT HFX HIP STEM SERIES
K
03
0766
OXINIUM FEMORAL HEADS
K
03
1734
GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS
K
03
1165
PLUS ORTHOPEDICS CEMENTED HIP STEM
K
03
0153
ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32
K
03
0265
CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
K
02
4340
SMITH & NEPHEW FEMORAL HEADS
K
02
2799
TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE
K
02
3646
EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM
K
02
3453
DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS
K
02
3085
RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM
K
02
2958
TOTAL HIP FEMORAL HEADS AND LINERS
K
02
2094
PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING
K
02
2077
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K
02
1822
R120 MODULAR TOTAL HIP SYSTEM
K
02
1380
OSS LES PROXIMAL FEMORAL COMPONENT
K
02
1310
36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
K
02
1178
SL-PLUS LATERALIZED STEM
K
02
0989
SUPER EON PLUS FEMORAL STEMS
K
02
0970
MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS)
K
02
0291
EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER
K
02
0076
PATRIOT PROTRUSIO CAGE
K
01
1887
AVALON CUP SYSTEM
K
01
3352
SUMMIT CEMENTED HIP PROSTHESIS
K
01
3350
MODIFICATION TO DEPUY C-STEM SYSTEM
K
01
2961
SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM
K
01
1774
R120 MODULAR TOTAL HIP SYSTEM
K
01
2493
ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0
K
01
1715
MACROPORE IB RESORBABLE PLUG
K
01
2019
COLOR BUFFED (CB) DDH FEMORAL STEM
K
01
2026
TRIDENT ALL POLY CUP
K
01
1455
BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER
K
01
1623
EXETER HIP SYSTEM WITH V40 TAPER
K
01
1367
EXCEL FRACTURE CEMENTED HIP STEM
K
01
1218
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1
K
01
0529
TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA
K
01
0757
LFIT V40 FEMORAL HEAD COMPONENTS
K
01
0310
MODIFICATION TO TRIDENT ALL POLY CUP
K
00
3975
BAUMER CEMENTED HIP PROSTHESIS
K
00
3976
BAUMER MULLER HIP PROSTHESIS
K
00
3666
TAPER-FIT TOTAL HIP SYSTEM
K
00
1956
TRIDENT ALL POLY CUP
K
00
3421
DEPUY C-STEM SYSTEM
K
00
2757
ONCOLOGY SALVAGE SYSTEM
K
00
2324
MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA
K
00
1759
HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ
K
00
1571
BAUMER FEMORAL HEAD
K
00
2106
NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER
K
00
1932
TORNIER CEMENT RESTRICTOR
K
00
1376
TI-MAX PROTRUSIO CAGE
K
00
1078
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
K
00
1733
ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES
K
00
0817
OMEGA II MODULAR TOTAL HIP SYSTEM
K
00
1335
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
K
99
0330
CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ
K
00
0254
PAR 5 ACETABULAR COMPONENT
K
99
4007
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
K
99
3713
RIM-FIX, ACETABULAR CUP
K
99
2409
THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ
K
99
2153
PE-PLUS ACETABULAR CUP
K
99
2903
COLOR BUFFED CEMENTED FEMORAL
K
99
2490
B2C HIP SYSTEM
K
99
1869
COBREX HIP STEM, MODEL 01-128-XXXXX
K
99
1622
26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER
K
99
2058
BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
K
99
1987
COLOR BUFFED ANSWER CEMENTED FEMORAL
K
99
1538
OPERA CUPFLANGED ACETABULAR COMPONENTS
K
99
1227
8MM FORGED CEMENTED STEM
K
99
0821
PROVIDENCE CUP SYSTEM
K
98
4227
OMEGA II MODULAR TOTAL HIP SYSTEM
K
99
0369
SYNERGY CEMENTED HIP STEM
K
99
0032
MODULAR PROTUSIO CUP
K
98
4154
APF POROUS COATED LINE EXTENSION
K
98
0926
DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION
K
98
0626
DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION
K
98
3226
OSTEONICS X CEMENTED HIP STEM SERIES
K
98
3128
IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY
K
98
3710
150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH
K
98
3136
DEPUY LUSTER STEM
K
98
2963
POLYMER THREADED ANCHOR / SUTURE COMBINATION
K
98
2918
DEPUY C-STEM SYSTEM
K
98
2670
CONTEMPORARY ACETABULAR COMPONENT
K
98
2598
OTI FEMORAL LOCK TOTAL HIP SYSTEM
K
97
4685
OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS
K
98
1855
PRINCE MEDICAL CEMENT PLUG
K
98
0813
RELIANCE LONG STEM FEMORAL COMPONENTS
K
98
0843
EXETER INTRAMEDULLARY BONE PLUG
K
98
0794
DUAL LOCK HIP STEM
K
98
0513
ARTICUL/EZE FEMORAL HEADS
K
98
0486
IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM
K
98
0286
ULTIMA ACETABULAR ROOF REINFORCEMENT RING
K
97
4558
SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM
K
97
2791
ENCORE LINEAR HIP
K
97
3809
FOUNDATION FRACTURE STEM
K
97
4054
DISTAL CENTRALIZER, EXETER II HIP SYSTEM
K
97
3453
TORNIER CEMENT RESTRICTOR
K
97
1681
SMC FEMORAL HIP COMPONENT
K
97
3296
EXTEND HIP STEM
K
97
2995
THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM
K
97
2961
STELKAST BIPOLAR SYSTEM
K
97
2928
KERBOULL CROSS
K
97
2792
DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS
K
97
2641
DUAL OFFSET PERFECTA IMC HIP STEM
K
97
2460
OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION)
K
97
2435
ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM
K
97
1890
RECOVERY PROTRUSIO CAGE
K
97
1705
IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED
K
97
1581
HEMISPHERE CEMENTED CUP
K
96
3612
DURATION STABILIZED UHMWPE
K
97
0697
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K
97
0194
PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT
K
96
5019
THE C-FIT FEMORAL HIP SYSTEM
K
96
4003
METAGEN ALL POLY ACETABULAR CUP SYSTEM
K
97
0351
GLOBAL TAPER SPECTRON HIP STEMS
K
96
4795
CEMENTED CALCAR REPLACEMENT FEMORAL STEM
K
96
4655
UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
K
96
3671
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
K
96
2468
HEDROCEL ACETABULAR RESTRICTOR
K
96
4350
MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA
K
96
3109
HERITAGE HIP SYSTEM
K
96
4218
PERFECTA PLASMA SPRAY HIP STEM
K
96
4262
EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD
K
96
3486
REVISION HIP SYSTEM
K
96
3313
EXACTECH ALL POLY ACETABULAR CUP
K
96
3206
S-ROM HIP SYSTEM - LOCKING PLUG
K
95
5137
IM C-MENT ACETABULAR CAP
K
96
0425
BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX
K
96
1304
AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM
K
96
2560
VITALITY HIP STEM
K
96
0984
SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS
K
96
0647
OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS
K
96
2267
PERFECTA PS REVISION STEM
K
96
2086
CPS, CEMENTED CUP SYSTEM
K
96
1899
CPS, CEMENTED HIP SYSTEM
K
96
0278
COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT
K
96
0658
COLLARLESS POLISHED TAPER HIP PROSTHESIS
K
96
1799
NATURAL HIP SYSTEM - DRG HIP STEM
K
96
1619
DEPUY ENDURANCE CALCAR HIP PROSTHESIS
K
96
0258
NATURAL HIP SYSTEM
K
96
1890
FOUNDATION 9MM FORGED CEMENTED STEM
K
96
0025
PROTEK LOW PROFILE ACETABULAR CUP
K
96
0678
BURCH/SCHNEIDER REINFORCEMENT CAGE
K
96
0626
MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST)
K
95
4598
OSTEONICS OFFSET HIP STEMS
K
96
0302
CONSENSUS ACETABULAR SHELL, ALL UHMWPE
K
96
0340
CONSENSUS APEX DOME HOLE PLUG
K
96
0339
CONSENSUS 22MM COCRMO FEMORAL HEAD
K
96
0151
CONSENSUS 26MM COCRMO FEMORAL HEAD
K
96
0156
CONSENSUS 32MM COCRMO FEMORAL HEAD
K
95
5620
PRIME CEMENTED CALCAR FEMORAL STEMS
K
95
5473
GAMMA SYSTEM
K
95
5296
LINK MP RECONSTRUCTION HIP
K
95
3200
ULTIMA SIZE 0 CEMENTED FEMORAL STEM
K
95
3202
P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT
K
95
2859
ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT
K
95
5354
ALTERNATIVE STERILIZATION PROCESS
K
95
4744
ZCH ALPHA SYSTEM
K
95
2970
HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM
K
95
2731
TOWNLEY ALL POLY ACETABULAR CUP
K
94
5774
BETA FEMORAL HIP STEM
K
93
5585
APR ACETABULAR INSERTS IOI BIPOLAR
K
95
4219
REALITY LONG STEM HIP SYSTEM
K
95
1139
ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K
95
4262
NEXUS II FEMORAL COMPONENT
K
95
3578
PROTEK ACETABULAR ROOF REINFORCEMENT RING
K
95
3033
PRIME CEMENTED SMALL FEMORAL STEM
K
95
3025
SLT 28MM XXL FEMORAL HEAD
K
95
2629
NEXFLEX TOTAL HIP SYSTEM
K
93
4857
HSS FEMORAL COMPONENTS
K
95
2191
FORGED CEMENTED STEM
K
93
5263
FOUNDATION POROUS STEM
K
95
2461
ENDO PROSTHESIS FEMORAL HEAD
K
95
1726
S-ROM ZTP UHMWPE ACETABULAR CUP
K
95
0418
ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL)
K
95
1084
S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS
K
94
5574
OSTEONICS(R) CCR HIP STEM SERIES
K
95
0312
ALPHA SYSTEM
K
94
3696
ALL POLYETHYLENE CEMENTED ACETABULAR CUP
K
95
0761
INDEX ACETABULAT COMPONENT
K
94
5115
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
K
94
4792
ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)
K
94
0328
PRIME CEMENTED HIP SYSTEM
K
94
6371
PROVIDENT HP SYSTEM
K
93
5449
FOUNDATION NON-POROUS STEM
K
94
0307
HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT
K
94
2537
PARAMOUNT CEMENTED HIP STEM PROTHESIS
K
94
3549
RESTORATION ACETABULAR CUP
K
93
0771
PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM
K
94
2370
DEPUY CEMENTED HIP PROSTHESIS
K
93
6127
HOWMEDICA PREMIUM FEMORAL COMPONENT
K
93
6126
HOWMEDICS DRG FEMORAL COMPONENT
K
94
3302
AML TRI-LOCK REPLACEMENT LINER SYSTEM
K
94
2966
AML TRILOCK REPLACEMENT LINER SYSTEM
K
94
1617
APR ACETABULAR INSERT
K
94
2406
OPTION SHELL
K
94
2611
FOUNDATION ALL POLY CUP
K
94
1486
INTEGRITY TOTAL HIP SYSTEM, NON-POROUS
K
93
0275
PRECISION OSTEOLOCK ACETABULAR COMPONENT
K
93
5951
KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM
K
93
5206
KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION
K
93
6214
CS-PLUS STEM
K
93
6132
EXETER ALL PLASTIC ACETABULAR COMPONENT
K
93
2481
SL-PLUS AND SLR-PLUS
K
93
3281
S.O.S. PROXIMAL FEMUR
K
93
6043
FOUNDATION POROUS ACETABULAR COMPONENT
K
93
4169
FOUNDATION ALL POLY CUP
K
93
2574
RMHS POROUS DISTAL SLEEVE
K
93
3561
OSTEONICS OMNIFIT FORGED HIP STEM SERIES
K
93
5012
BIOMETRIC TOTAL HIP SYSTEM
K
93
0187
OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS
K
93
3875
PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE
K
90
3630
PRECISION OSTEOFLEX FEMORAL COMPONENT
K
93
0460
HOWMEDICA REVISION HIP SYSTEM
K
93
0223
HOWMEDICA ACETABULAR SHELL
K
92
6229
APC FEMORAL COMPONENT
K
92
3243
PERFECTA TOTAL HIP SYSTEM
K
93
0812
APR FEMORAL HIP COMPONENT
K
92
5866
CENATOR TOTAL HIP SYSTEM
K
93
0108
RMHS POROUS DISTAL SLEEVE
K
92
5201
EXACTECH FEMORAL STEM
K
92
6323
H-110 ACETABULAR CUP SYSTEM
K
90
5262
BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH
K
92
5348
IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM
K
91
5594
STABILITY HIP FEMORAL COMPONENT
K
92
3275
RMHS MONOLITHIC FEMORAL COMPONENT
K
92
2847
PERFECTA TOTAL HIP SYSTEM
K
91
1058
TECHMEDICA CAD/CAM CUSTOM HIP
K
92
4323
THE UNIVERSAL BONE CEMENT RESISTOR
K
92
2860
AUSTIN-MOORE TYPE HIP PROSTHESIS
K
92
2862
CHARNLEY TYPE HIP PROTHESIS
K
92
2866
OTI BONE PLUG
K
92
2864
MUELLER TYPE FEMORAL STEM
K
92
2863
EUROSTEM HIP PROTHESIS SYSTEM
K
92
2871
UNIFIT FEMORAL STEM
K
92
5895
ETEX HIP REPLACEMENT SYSTEM
K
92
2733
PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP
K
92
2645
LSF ANATOMIC CEMENTED HIP
K
91
4078
DEPUY HIP PROSTHESIS
K
92
4115
ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS
K
92
0739
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K
92
3898
C-FIT CEMENTED HIP STEM
K
91
5500
LESTER PRESS FIT HIP PROSTHESIS
K
92
2421
KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP
K
92
2503
HOWMEDICA(R) HNR SYSTEM
K
91
4675
MODULAR FEMORAL HEAD WITH OFFSET TRUNION
K
92
2008
CDH HIP SYSTEM
K
91
4878
ZIRCONIUM ALLOY FRMORAL HEAD
K
92
0430
MODULAR ACETABULAR CUP SYSTEM
K
92
0639
RX 90 ACETABULAR COMPONENT SYSTEM
K
92
0640
FULL HEMISPHERE RING-LOC LINER
K
92
1383
PRECISION STRATA TOTAL HIP STEM
K
92
0286
DEPUY TOTAL HIP BALLS - ION IMPLANTATION
K
92
0250
OSTEONICS MICROSURFACED CDH HIP STEM
K
92
0161
BIOMET NTS FEMORAL COMPONENTS
K
92
0021
LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP
K
92
0317
S-ROM LF FEMORAL HEAD
K
92
0003
DRG CEMETED STEM
K
91
5795
PERFECTA PDA TOTAL HIP SYSTEM
K
91
5216
SOLUTION SYSTEM CUP
K
91
1802
PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP
K
91
4406
PT II DISTAL CEMENT SPACER
K
91
3231
S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD
K
91
2712
BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS
K
91
3634
APR II HIP SYSTEM
K
91
3874
INFINITY(TM) MICROTAPER HIP SYSTEM
K
91
3812
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES
K
91
3649
MODULAR CALCAR REPLACEMENT
K
91
3616
LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP
K
91
3246
HYBRID FIT TOTAL HIP SYSTEM
K
91
3208
APR II NON-POROUS HIP STEM
K
91
3060
NATURAL POROUS HIP SYSTEM
K
91
2593
MODULAR HIP SYSTEM
K
91
2916
APR COLLAR SPACER
K
91
2426
UHMWP ACETABULAR COMPONENT
K
91
1890
OSTEONICS(R) PRT HIP STEM SERIES
K
90
4737
GROSS HIP FEMORAL COMPONENT
K
91
1718
M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST)
K
91
1685
RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP
K
91
0093
FUTURA FEMORAL HIP STEM
K
91
1684
BIOMET COBALT-CHROME FEMORAL COMPONENTS
K
91
1052
NEXUS(TM) FEMORAL HIP STEM
K
90
5298
TITAN TOTAL HIP DEVICE
K
91
0836
LIMA COLLARED CL STEM
K
91
0352
BIOPRO METAL BACKED CEMENTED ACETABULAR CUP
K
91
0869
HOWMEDICA(R) CEMETED FEMORAL COMPONENT
K
90
5258
S-ROM OBLONG ACETABULAR CUP
K
91
0662
PS OMNIFIT NORMALIZED HIP STEM SERIES
K
91
0922
OSTEONICS CDH HIP STEM
K
91
0988
OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES
K
90
5408
NEXUS ACETABULAR CUP
K
90
5275
OSTEONICS(R) MPSS HIP STEM SERIES
K
90
5406
OSTEONICS HIP REVISION WEDGES
K
90
5158
OSTEONICS(R) 6011 HIP STEM SERIES
K
90
4207
BIOPRO TRINITY ACETABULAR CUP
K
90
3938
C FIT CUP
K
89
6851
PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC
K
90
4919
PROXIMAL FEMUR REPLACEMENT STEM
K
90
4844
PRECISION HIP STEM WITH ADDITIONAL STEM SIZES
K
90
3957
VSP HIP STEM
K
90
3635
PERFECTA TOTAL HIP SYSTEM
K
90
3636
OSTEONICS DRM ACETABULAR COMPONENT
K
90
3116
RM ISOELASTIC BEVELLED ACETABULAR CUP
K
90
3362
OSTEOLOCK(TM) ACETABULAR CUP
K
90
4351
FOCUS COBALT CHROMIUM TOTAL HIP
K
90
3234
F-19 TOTAL HIP PROSTHESIS
K
90
2961
DIMENSION-II TOTAL HIP SYSTEM
K
90
0261
ACSYS PREFIX ACETABULAR CUP PROSTHESIS
K
90
2621
SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT
K
90
1451
F-20 CEMENTED METAL-BACKED ACETABULAR CUP
K
90
2436
HG MULTILOCK HIP PROSTHESIS W/TINIDIUM SURFACE
K
90
2395
MODIFIED AML + ACETABULAR CUP SYSTEM
K
90
2396
MODIFIED DEPUY ACETABULAR CUP SYSTEM
K
90
2727
LSF CEMENTED FEMORAL HIP
K
90
2279
KM-5 METAL BACKED ACETABULAR CUP
K
90
3243
MULLER-TYPE FEMORAL COMPONENT
K
90
3242
ACETABULAR CUP
K
90
2137
P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT
K
90
1480
F-20 TOTAL HIP PROSTHESIS
K
90
1460
LSF(TM) TOTAL HIP SYSTEM
K
90
1328
DOMED AND FINNED ACETABULAR COMPONENT
K
90
1364
HGP II TOTAL HIP FEMERAL STEM
K
90
1087
MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS
K
90
0832
MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA.
K
90
1297
EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP
K
90
0438
MC2P ACETABULAR COMPONENT
K
90
0257
MULLER TYPE ACETABULAR CUP
K
90
1240
ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED
K
90
0836
OSTEONICS ECSI HIP STEM SERIES
K
90
0891
MODIFIED AML + ACETABULAR CUP PROSTHESIS
K
89
5036
TITANIUM MODULAR MODULAR COLLARLESS HIP
K
89
5035
TITANIUM MODULAR COLLARED HIP PROSTHESIS
K
89
6325
QUANTUM HIP STEM
K
89
5636
DIMENSION REVISION TOTAL HIP SYSTEM
K
88
4890
LORD L.F.R. TOTAL HIP SYSTEM
K
89
3821
ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST.
K
89
0498
FREEMAN MODULAR HIP STEM RIDGED VERSION
K
89
4298
MODIFIED GEMINI ACETABULAR CUP
K
89
4149
MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL
K
89
4148
MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL
K
89
4249
UNIVERSAL CEMENTED CUP
K
88
5192
APR COLLARED REVISION FEMORAL COMPONENT
K
89
1454
EXETER II TOTAL HIP SYSTEM
K
89
0742
INTRAFORM TOTAL HIP SYSTEM
K
88
4027
PERFECTA II/NON-COATED TOTAL HIP SYSTEM
K
88
5338
AML BOWED FEMORAL HIP
K
89
0649
OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST.
K
89
0054
M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI.
K
88
4888
MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS
K
88
3618
PERFECTA II TOTAL HIP SYSTEM
K
88
4432
MODIFIED LSF TOTAL HIP SYSTEM
K
88
3941
PROFORMA HIP SYSTEM
K
88
4457
MODULAR COLLARED HJD TOTAL HIP SYSTEM
K
88
3724
GEMINI FEMORAL HIP PROSTHESIS
K
88
2869
TOWNLEY COX COMB ACETABULAR COMPONENT
K
88
3460
FOCUS TOTAL HIP SYSTEM
K
88
2146
BIOPRO PC FEMORAL HIP COMPONENT
K
88
2812
OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM
K
88
0435
PROFORMA/PS TOTAL HIP SYSTEM
K
88
1769
HJD CALCAR REPLACEMENT PROSTHESIS
K
88
0269
LCS FEMORAL HIP PROSTHESIS
K
88
1117
RESUBMITTING OF HJD TOTAL HIP SYSTEM
K
87
1867
ELITE MODULAR HIP SYSTEM
K
88
0390
INTRAFORM TOTAL HIP SYSTEM
K
88
1128
TITANIUM FEMORAL HIP
K
88
0461
PERFECTA TOTAL HIP SYSTEM
K
88
0004
TOWNLEY COX COMB ACETABULAR CUP
K
87
1852
COXA ACETABULAR CUP
K
87
4619
SPECTRON EF ACETABULAR COMPONENT
K
87
4599
MOORE HIP PROSTHESIS SOLID STEM
K
87
4616
MOORE HIP PROSTHESIS FENESTRATED STEM
K
87
4093
SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP
K
87
3626
FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM
K
87
3632
HI-NEK TOTAL HIP
K
87
3857
WHITESIDE ORTHOLOC REVISION HIP STEM PROSTHESIS
K
87
4229
ANATOMIC TOTAL HIP
K
87
3999
PREMIER-TOTAL (TM) HIP
K
87
3585
POROUS COATED ACETABULAR CUP
K
87
0922
C.L.E. ACETABULAR CUP
K
87
2732
MCCUTCHEN ACETABULAR CUP PROSTHESIS
K
86
4999
KENNEDY STEM
K
87
2856
BIOPRO 32MM BALL
K
87
1402
MURRAY/WELCH TOTAL HIP SYSTEM
K
87
1347
WAGNER REVISIONAL FEMORAL HIP PROSTHESIS
K
87
1857
HPS II CALCAR FEMORAL PROSTHESIS
K
87
1462
PROSTHETIC - FEMORAL HIP COMPONENT
K
87
0235
OMNIFIT II HIP PROSTHESES: CEMENT FIXATION
K
87
1401
KIRSCHNER MODULAR HIP SYSTEM
K
87
0128
HARTFORD TOTAL HIP SYSTEM (TRI-WEDGE)
K
87
0699
STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP
K
87
1299
SDI TOTAL HIP SYSTEM
K
86
4857
OPTI-FIX ACETABULAR COMPONENT
K
87
0445
THREADED ACETABULAR COMPONENT
K
87
0216
MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS
K
86
1988
MODIFIED PROTASUL 100 (TI-6A1-7NB) ALLOY
K
86
3184
PROFILE HIP ACETABULUM PROSTHESIS
K
86
1979
AML II TITANIUM ACETABULUM PROSTHESIS
K
86
1433
UNIVERSAL ACETABULAR COMPONENT
K
86
2234
EXACTECH TOTAL HIP SYSTEM
K
86
2225
INTERNATIONAL TOTAL HIP SYSTEM
K
86
1930
CM-6 TOTAL HIP SYSTEM
K
85
5017
LSF* TOTAL HIP SYSTEM
K
86
1114
MALLORY/HEAD - PF ACETABULAR COMPONENT
K
86
0002
CONICAL COLLAR HIP PROSTHESIS POROUS COATED
K
85
5200
MODULAR PRESS FIT (MPF) STEM
K
86
0701
HPS II SMOOTH STEM
K
85
4465
LINK CONTOUR RIBBED HIP PROSTHESES SYSTEM
K
85
3916
P.M. HIP-FEMORAL PROSTHESIS
K
84
4050
ARTHOPOR-ACETABULAR COMPONENT
K
85
3886
P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM
K
85
4046
CONICAL COLLAR HIP PROSTHESIS
K
85
3768
MULLER SELF LOCKING TOTAL HIP
K
85
3408
COLLAR LESS AML HIP
K
85
3169
GT HIP PROSTHESIS FEMORAL COMPONENT
K
85
2839
FREEMAN HIP
K
85
3655
NEW JERSEY MODULAR FEMORAL HIP
K
84
4319
KM-2 METAL-BACKED ACETABULAR CUP
K
85
2517
CLS HIP PROSTHESIS
K
85
1422
S-ROM 135 FEMORAL STEM & COLLAR(PART OF S-ROM HIP
K
85
2585
POROUS APF/MODULAR FEMORAL COMPONENT
K
85
2546
HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY
K
85
2153
THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP
K
85
2705
LIDGREN-LUND FEMORAL DYSPLASIA HIP PROSTHESIS SYS
K
84
4787
BIOMETRIC TOTAL HIP SYSTEM
K
84
4817
MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM
K
84
4941
CFE ACETABULAR CUP
K
84
5005
BROOKER ACETABULAR CUP
K
84
4028
LORD SCREW RING ACETABULAR COMPONENT
K
84
3190
HAP ACETABULAR CUP
K
84
3909
TITANIUM HIP 1019
K
84
2360
DORR HIP PROSTHESIS FEMORAL COMPONENT
K
84
2906
BIAS TOTAL HIP
K
84
2202
NEW JERSEY ACETABULAR COMPONENT &
K
83
4035
UNIVERSAL SELF-ALIGNING ACETABULAR COM
K
84
0643
HARRIS-GALANTE POROUS TOTAL HIP SYS
K
84
1391
WEBER-STUHMER HIP PROSTHESIS STEM
K
84
0150
TOTAL HIP FEMORAL COMPONENT
K
84
0357
SSA HIP PROSTHESIS
K
83
3881
ACETABULAR SCREW RING
K
83
3912
GALANTE FIBER METAL TOTAL HIP
K
83
2958
FREEMAN ACETABULAR CUP
K
83
2211
DOSIMETRIC RELEASE OF GAMMA RADIATION
K
83
0361
MMS ACETABULAR CUPS
K
83
1884
SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL
K
83
1373
P.C.A. HIP SYSTEM
K
83
1986
METAL-BACKED ACE TABULAR CUP
K
83
1314
INTERFERENCE MEDULLARY FIT -IMF-HIP
K
83
0948
WEBER/STIIHMER FEMORAL HEAD PROSTHESIS
K
83
0314
MILWAUKEE AUSTIN MOORE TOTAL HIP
K
83
0313
CFE TOTAL HIP FEMORAL COMPONENT
K
83
0209
LUS ACETABULAR COMPONENT
K
83
0857
HARRIS A.R. C. ACETABULAR CUP
K
83
0750
CEMENTED 101 32 FEMORAL COMPONENT
K
83
0004
POROCOAT DUAL-LOCK TOTAL HIP SYSTEM
K
83
0356
TITANIUM M.E. MULLER TYPE TOTAL HIP
K
82
3723
SPECTRON PROXIMAL FEMORAL PROSTHESIS
K
82
3724
SPECTRON NECK REPLACEMENT PROSTHESIS
K
82
3727
SPECTRON PRIMARY STEM FEMORAL PROSTHES
K
82
3722
SPECTRON LONG, STRAIGHT FEMORAL PROSTHES
K
82
3725
SPECTRON PROTRUSIO CUP
K
82
3729
SPECTRON METAL BACK ACETABULAR COMPONENT
K
82
3728
SPECTRON POLYETHYLENE ACCTUBULAR COMPON
K
82
3419
HC 1M METALBACKED ACETABULAR CUP
K
82
2979
CEMENTLESS ZWEYMUELLER HIP ENDOPROTHES
K
82
1893
ZIMMER METAL BACKED ACETABULAR CUP
K
82
1714
POROCOAT STANDARD METAL BACKED CUP
K
82
1713
POROCOAT LOW PROFILE METAL BACKED CUP
K
82
1369
TITANIUM AUFRANC-TURNER ATS HIP SYS
K
82
1066
CONTOUR II LINK SP TOTAL HIP PROSTHESIS
K
81
3600
AUFRANC-TURNER TYPE ACETABULAR COMPON
K
81
3089
CEMENT RING
K
81
2801
HIP STEM SYSTEM TITANIUM ALLOY
K
80
2342
PROXIMAL INTERPHALANGEAL JOINT IMPLANT
K
81
2182
MIAMI, PROTRUSIO RING
K
81
1293
EFTEKHAR CENTRALIZING PLUG
K
81
1151
COLLARLESS TOTAL HIP FEMORAL COMP. SYS
K
80
3126
EXETER TOTAL HIP SYSTEM
K
81
0120
REINFORCED HIP CUP
K
80
3074
FERNORAL HIP PROSTHESIS
K
80
2627
ORTRON 90* HIP PROSTHESIS
K
80
2872
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K
80
0487
3M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM
K
79
0488
INTERPLANTA SP TOTAL HIP PROSTHESIS
K
78
0398
CUP, ACETABULAR, LONG POSTERIOR WALL
K
78
0317
TOTAL HIP SYSTEM, HARRIS HD2
K
78
0052
PROSTHESIS, DOUBLE CUP
K
77
0908
PROSTHESIS, HIP, TRAPEZOIDAL-28
JDL
Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
JDN
Implant, Fixation Device, Spinal
JDO
Device, Fixation, Proximal Femoral, Implant
JDP
Condylar Plate Fixation Implant
JDQ
Cerclage, Fixation
JDR
Staple, Fixation, Bone
JDS
Nail, Fixation, Bone
JDT
Cap, Bone
JDW
Pin, Fixation, Threaded
JEC
Component, Traction, Invasive
JWH
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
JWI
Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
JWJ
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
KIG
Prosthesis, Wrist, Constrained, Polymer
KMB
Prosthesis, Knee, Non-Constrained (Metal-Carbon Reinforced Polyethylene) Cemented
KMC
Prosthesis, Hip, Semi-Constrained, Composite/Metal
KMD
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Composite
KRN
Metal Cemented Constrained Femorotibial Knee Prosthesis
KRO
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
KRP
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Metal
KRQ
Prosthesis, Knee, Patello/Femorotibial, Constrained, Cemented, Polymer/Metal/Polymer
KRR
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
KRS
Prosthesis, Knee, Hemi-, Femoral (Uncemented)
KTT
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
KTW
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
KTX
Prosthesis, Knee, Femorotibial, Non-Constrained, Metal/Composite Cemented
KWA
Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
KWB
Prosthesis, Hip, Hemi-, Acetabular, Cemented, Metal
KWD
Prosthesis, Toe, Hemi-, Phalangeal
KWE
Prosthesis, Finger, Constrained, Metal, Uncemented
KWF
Prosthesis, Finger, Polymer
KWG
Prosthesis, Finger, Constrained, Metal/Polymer
KWH
Prosthesis, Toe, Constrained, Polymer
KWI
Prosthesis, Elbow, Hemi-, Radial, Polymer
KWJ
Prosthesis, Elbow, Hemi-, Humeral, Metal
KWK
Appliance, Nail/Blade/Plate Combination, Single Component
KWL
Prosthesis, Hip, Hemi-, Femoral, Metal
KWM
Prosthesis, Wrist, Semi-Constrained
KWN
Prosthesis, Wrist, Carpal Lunate
KWO
Prosthesis, Wrist, Carpal Scaphoid
KWP
Appliance, Fixation, Spinal Interlaminal
KWQ
Appliance, Fixation, Spinal Intervertebral Body
KWR
Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
KWS
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWT
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
KWY
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
KWZ
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
KXA
Prosthesis, Hip, Femoral, Resurfacing
KXB
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer
KXC
Prosthesis, Ankle, Cemented, Non-Constrained
KXD
Prosthesis, Hip, Constrained, Metal
KXE
Prosthesis, Wrist, Hemi-, Ulnar
KYI
Prosthesis, Wrist, Carpal Trapezium
KYJ
Prosthesis, Finger, Constrained, Polymer
KYK
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Composite
KYM
Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
KYN
Prosthesis, Wrist, Constrained, Metal
LBC
Prosthesis, Finger, Constrained, Metal, Cemented
LGE
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Trunnion-Bearing
LOD
Bone Cement
LPH
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
LRN
Wire, Surgical
LTO
Spacer, Cement
LWJ
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
LXT
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
LYP
Accessories, Fixation, Spinal Interlaminal
LYT
Fixation Accessory
LZO
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
LZY
Prosthesis, Hip, Hemi-, Femoral, Metal Ball
MAI
Fastener, Fixation, Biodegradable, Soft Tissue
MAX
Intervertebral Fusion Device With Bone Graft, Lumbar
MAY
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish
MBB
Bone Cement, Antibiotic
MBF
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
MBH
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
MBI
Fastener, Fixation, Nondegradable, Soft Tissue
MBL
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
MBP
Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
MBV
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer
MEH
Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
MJW
Prosthesis, Subtalar, Plug, Polymer
MNH
Orthosis, Spondylolisthesis Spinal Fixation
MNI
Orthosis, Spinal Pedicle Fixation
MNU
Staple, Absorbable
MQP
Spinal Vertebral Body Replacement Device
MQV
Filler, Bone Void, Calcium Compound
MRY
Appliances And Accessories, Fixation, Bone, Absorbable Single/Multiple Component
NDD
Cerclage, Fixation, Metallic
NDE
Rod, Fixation, Intramedullary And Accessories, Metallic And Non-Collapsible
NDF
Plate, Fixation, Bone, Non-Spinal, Metallic
NDG
Washer, Bolt, Nut, Non-Spinal, Metallic
NDJ
Screw, Fixation, Bone, Non-Spinal, Metallic
NDK
System, External Fixator (With Metallic Invasive Components)
NDL
Pin, Fixation, Smooth, Metallic
NDM
Pin, Fixation, Threaded, Metallic
NDN
Cement, Bone, Vertebroplasty
NJA
Accessory, System, External Fixator, Containing Antimicrobial Agent
NJD
Prosthesis, Knee, Femorotibial, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer
NKB
Thoracolumbosacral Pedicle Screw System
NKG
Posterior Cervical Screw System
NOV
Anchor, Suture, Bone Fixation, Metallic
NPJ
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NQP
Posterior Metal/Polymer Spinal System, Fusion
NQW
Orthosis, Spine, Plate, Laminoplasty, Metal
NUD
Vertebroplasty Compound, Calcium Based
NVC
Bone, Heterograft
NWN
Laparoscopic Bone Anchor Urethropexy Instrument Kit
OBL
Cement, Bone, Pre-Formed, Modular, Polymeric, Vertebroplasty
OBM
Cement, Bone, Vertebroplasty, Pre-Formed, Modular
OBT
Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
OCG
Prosthesis, Hip, Pelvifemoral Resurfacing, Metal/Polymer, Uncemented
ODP
Intervertebral Fusion Device With Bone Graft, Cervical
OIS
Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation
OIY
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
OJB
Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate
OJM
Resorbable Spinal Intervertebral Body Fixation Orthosis - Mesh
OOG
Knee Arthroplasty Implantation System
OOL
Electronic Depth Gauge
OQB
Intervertebral Body Graft Containment Device
OQG
Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
OQH
Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
OQI
Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
OSH
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
OSN
Software For Diagnosis/Treatment
OUR
Sacroiliac Joint Fixation
OVD
Intervertebral Fusion Device With Integrated Fixation, Lumbar
OVE
Intervertebral Fusion Device With Integrated Fixation, Cervical
OVZ
Pin, Fixation, Resorbable, Hard Tissue
OWI
Bone Fixation Cerclage, Sublaminar
OYK
Ankle Arthroplasty Implantation System
OZI
Internal Hinged Elbow Fixator
PAO
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
PBF
Orthopaedic Surgical Planning And Instrument Guides
PBI
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
PEK
Spinous Process Plate
PHM
Intervertebral Fusion Device With Bone Graft, Thoracic
PHQ
Anterior Staple As Supplemental Fixation For Fusion
PHX
Shoulder Prosthesis, Reverse Configuration
PKC
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
PLF
Bone Wedge
PLR
Spinal Vertebral Body Replacement Device - Cervical
PLW
Acetabular Cup Orientation System
PML
Bone Cement, Posterior Screw Augmentation
PPQ
Transtibial Anterior Cruciate Ligament Kit
QHQ
Total Shoulder Arthroplasty System
PQC
Pedicle Screw Placement Guide
QAC
Screw Sleeve Bone Fixation Device
QAD
Rod, Fixation, Intramedullary And Accessories, In-Vivo Cured, Light-Activated
QFP
Intraoperative Orthopedic Strain Sensor
QHE
Shoulder Arthroplasty Implantation System
QNI
Resorbable Implant For Anterior Cruciate Ligament (Acl) Repair
QPP
Implantable Post-Surgical Kinematic Measurement Knee Device
QPQ
Shoulder Spacer For Massive Irreparable Rotator Cuff Tear, Resorbable, Inflatable, Non-Fixed
JDJ
Mesh, Surgical, Acetabular, Hip, Prosthesis
JDK
Prosthesis, Hip, Cement Restrictor
LZN
Cement Obturator
OLC
Scaffold, Partial Medial Meniscal Defects Extending Into The Red/White Zone, Resorbable Bovine Collagen
QSD
Posterior Cervical Screw Placement Guide
QSR
Sacroiliac Screw Placement Guide
QVI
Screw Sleeve Bone Fixation Device, Spine
QUW
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
QWJ
Mesh, Surgical, Polymeric, Resorbable, Orthopedics, Reinforcement Of Ligament
SAI
Ankle Fusion Cage
SCY
Sacroiliac Joint Guidewire Placement Device
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OR
/
subpart-d—prosthetic-devices
/
JDI
/
K010757
View Source
LFIT V40 FEMORAL HEAD COMPONENTS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K010757
510(k) Type
Special
Applicant
HOWMEDICA OSTEONICS CORP.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
4/11/2001
Days to Decision
29 days
Submission Type
Summary