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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
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
K
23
4028
COPAL® exchange G hip spacer; COPAL® G+V
2
Cleared 510(K)
K
22
2632
UHR Bipolar Implants, Restoration GAP II Implants
2
Cleared 510(K)
K
19
2995
OsteoRemedies Hip Spacer System
2
Cleared 510(K)
K
19
1981
REMEDY Acetabular Cup
2
Cleared 510(K)
K
17
2906
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
2
Cleared 510(K)
K
17
3967
Remedy Acetabular Cup
2
Cleared 510(K)
K
14
3184
Evolve UniPolar Head
2
Cleared 510(K)
K
11
2470
2GC HIP/KNEE MODULAR SPACER
2
Cleared 510(K)
K
10
1356
Spacer-G and Spacer-K
2
Cleared 510(K)
K
11
1911
CORIN OPTIMOM MODULAR HEAD
2
Cleared 510(K)
K
06
2273
SPACER-G TEMPORARY HIP PROSTHESIS
2
Cleared 510(K)
K
07
1471
CORIN ADAPTOR SLEEVE
2
Cleared 510(K)
K
06
3791
CORIN UNIPOLAR MODULAR HEAD
2
Cleared 510(K)
K
06
2408
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
2
Cleared 510(K)
K
06
1243
SMITH & NEPHEW MODULAR FEMORAL HEAD
2
Cleared 510(K)
K
04
2973
SOLITUDE UNIPOLAR HEAD
2
Cleared 510(K)
K
03
1841
SPACER G TEMPORARY HIP PROSTHESIS
2
Cleared 510(K)
K
03
0972
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
2
Cleared 510(K)
K
03
0205
CONSENSUS UNIPOLAR HEAD, COCR
2
Cleared 510(K)
K
01
4226
UNITRAX MODULAR UNIPOLAR SYSTEM
2
Cleared 510(K)
K
99
2570
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
2
Cleared 510(K)
K
99
0309
PLUS FRACTURE HEAD PROSTHESIS
2
Cleared 510(K)
K
98
4585
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
2
Cleared 510(K)
K
98
4028
THE NEW BIO-MOORE ENDO HEADS
2
Cleared 510(K)
K
98
1451
ARGOMEDICAL BIPOLAR SYSTEM
2
Cleared 510(K)
K
97
4807
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
2
Cleared 510(K)
K
97
3614
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
2
Cleared 510(K)
K
96
5198
ULTIMA TPS CEMENTED STEM
2
Cleared 510(K)
K
96
5156
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
2
Cleared 510(K)
K
96
2646
PRIME MODULAR ENDO HEAD
2
Cleared 510(K)
K
96
0538
OPTEON UNIPOLAR
2
Cleared 510(K)
K
95
5385
JOHNSON & JOHNSON AUSTIN MOORE STEM
2
Cleared 510(K)
K
95
4534
OSTEONICS UNIPOLAR ENDO HEAD
2
Cleared 510(K)
K
95
4077
UNITRAX V40 MODULAR ADAPTOR
2
Cleared 510(K)
K
94
3778
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
2
Cleared 510(K)
K
95
0563
ULTIMA AUGMENTED UHMWPE CUP
2
Cleared 510(K)
K
95
1355
LINK SADDLE PROTHESIS
2
Cleared 510(K)
K
93
1753
CORIN THOMPSON PROSTHESIS, MODIFICATION
2
Cleared 510(K)
K
93
1752
CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION
2
Cleared 510(K)
K
94
0190
ULTIMA UNIPOLAR MODULAR HEAD
2
Cleared 510(K)
K
93
4353
ZIRCONIUM ALLOY UNI-POLAR HEAD
2
Cleared 510(K)
K
92
4050
TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT
2
Cleared 510(K)
K
92
6120
CONTOUR FEMORAL HIP STEM WITH POROCOAT
2
Cleared 510(K)
K
92
4379
ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM
2
Cleared 510(K)
K
92
2146
OSTRONCS HEMI-HIP STEM SERIES
2
Cleared 510(K)
K
92
0231
OMNIFIT M-HA HIP STEM SERIES
2
Cleared 510(K)
K
92
0193
OMNIFLEX M-HA HIP STEM SERIES
2
Cleared 510(K)
K
91
5868
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
2
Cleared 510(K)
K
90
3877
MTS FEMORAL HIP SYSTEM
2
Cleared 510(K)
K
90
2365
MODULAR UNIPOLAR SYSTEM
2
Cleared 510(K)
K
90
5334
THOMPSON TYPE HIP PROSTHESIS
2
Cleared 510(K)
K
90
5349
AUSTIN MOORE TYPE HIP PROTHESIS
2
Cleared 510(K)
K
90
4119
PROFILE COLLARED HIP PROSTHESIS
2
Cleared 510(K)
K
90
3884
KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD
2
Cleared 510(K)
K
90
3885
KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD
2
Cleared 510(K)
K
90
3241
AUSTIN MOORE TYPE HIP PROSTHESIS
2
Cleared 510(K)
K
90
3240
THOMPSON TYPE HIS PROSTHESIS
2
Cleared 510(K)
K
89
6853
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
2
Cleared 510(K)
K
90
0638
P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT
2
Cleared 510(K)
K
89
6105
EVOLUTION HIP SYSTEM
2
Cleared 510(K)
K
89
5886
BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM
2
Cleared 510(K)
K
89
1482
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
2
Cleared 510(K)
K
88
4889
MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
2
Cleared 510(K)
K
88
4789
NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI
2
Cleared 510(K)
K
88
3179
HIP FRACTURE STEM SYSTEM
2
Cleared 510(K)
K
87
4915
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS
2
Cleared 510(K)
K
87
2535
BIOPRO FEMORAL HIP COMPONENT
2
Cleared 510(K)
K
87
2776
PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT
2
Cleared 510(K)
K
87
2025
POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS
2
Cleared 510(K)
K
87
2878
TRI-LOCK MODIFIED FEMORAL PROSTHESIS
2
Cleared 510(K)
K
87
1656
ORTHOMET AUSTIN-MOORE SYSTEM
2
Cleared 510(K)
K
86
4085
BROOKER BIO-GROOVE FEMORAL COMPONENT
2
Cleared 510(K)
K
85
4791
BIO-FIT HIP SYSTEM
2
Cleared 510(K)
K
85
5228
FEMORAL HEMI-HIP PROSTHESES
2
Cleared 510(K)
K
85
3662
MUELLER CURVED STEM HEMI-PROSTHESIS
2
Cleared 510(K)
K
85
2584
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
2
Cleared 510(K)
K
84
4818
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS
2
Cleared 510(K)
K
85
2420
BTM TOTAL HIP SYSTEM
2
Cleared 510(K)
K
85
0928
V.E.P. HIP -VARIABLE ENDO-PROSTHESIS
2
Cleared 510(K)
K
84
3995
TF-II HIP PROSTHESIS
2
Cleared 510(K)
K
84
5025
AUSTIN-MOORE MODULAR HIP PROSTHESIS
2
Cleared 510(K)
K
84
4488
MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS
2
Cleared 510(K)
K
84
4487
MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR
2
Cleared 510(K)
K
84
4486
MECRON MRC-HEADLESS FEMORAL COMPONENT
2
Cleared 510(K)
K
84
2559
WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
2
Cleared 510(K)
K
84
2465
UNILOC
2
Cleared 510(K)
K
84
2234
NEW JERSEY FEMORAL STEM
2
Cleared 510(K)
K
84
1437
PENNSYLVANIA HOSPITAL HIP SYS
2
Cleared 510(K)
K
83
3599
MODIFIED HPS HIP PROSTHESIS
2
Cleared 510(K)
K
83
3403
BDH UNIPOLAR FEMORAL COMPONENT A2
2
Cleared 510(K)
K
83
1851
STRAIGHT STEM FEMORAL HEAD PROSTHESIS
2
Cleared 510(K)
K
83
1420
HIP PROSTHESIS -VARIOUS
2
Cleared 510(K)
K
83
0307
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
2
Cleared 510(K)
K
82
3051
METAL KNEE & HIP PROSTHESIS
2
Cleared 510(K)
K
82
2321
IOI 32 TM FEMORAL COMPONENT
2
Cleared 510(K)
K
82
2320
KAMPNER FEMORAL COMPONENT
2
Cleared 510(K)
K
82
0755
THE ORIGINAL LEINBACH PLATFORM TOTAL HIP
2
Cleared 510(K)
K
82
1343
BDH FEMORAL COMPONENT
2
Cleared 510(K)
K
81
1416
MOORE HIP PROSTHESIS, PMMA COATED
2
Cleared 510(K)
K
81
1738
COLLARLESS TAPERED STEM HIP PROSTH. DEV
2
Cleared 510(K)
K
80
3191
PROSTHESIS, HIP FEMORAL COMPONENT METAL
2
Cleared 510(K)
K
80
0207
UHR UNIVERSAL6HIP REPLACEMENT
2
Cleared 510(K)
K
79
2181
3M HS 22 FEMORAL COMPONENT
2
Cleared 510(K)
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 16 May 2025 at 11:05 pm
OR
/
subpart-d—prosthetic-devices
/
KWL
/
K903877
View Source
MTS FEMORAL HIP SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K903877
510(k) Type
Traditional
Applicant
3M COMPANY
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/18/1991
Days to Decision
149 days
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
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
K
23
4028
COPAL® exchange G hip spacer; COPAL® G+V
K
22
2632
UHR Bipolar Implants, Restoration GAP II Implants
K
19
2995
OsteoRemedies Hip Spacer System
K
19
1981
REMEDY Acetabular Cup
K
17
2906
REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement
K
17
3967
Remedy Acetabular Cup
K
14
3184
Evolve UniPolar Head
K
11
2470
2GC HIP/KNEE MODULAR SPACER
K
10
1356
Spacer-G and Spacer-K
K
11
1911
CORIN OPTIMOM MODULAR HEAD
K
06
2273
SPACER-G TEMPORARY HIP PROSTHESIS
K
07
1471
CORIN ADAPTOR SLEEVE
K
06
3791
CORIN UNIPOLAR MODULAR HEAD
K
06
2408
SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD
K
06
1243
SMITH & NEPHEW MODULAR FEMORAL HEAD
K
04
2973
SOLITUDE UNIPOLAR HEAD
K
03
1841
SPACER G TEMPORARY HIP PROSTHESIS
K
03
0972
FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION MH)
K
03
0205
CONSENSUS UNIPOLAR HEAD, COCR
K
01
4226
UNITRAX MODULAR UNIPOLAR SYSTEM
K
99
2570
UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE
K
99
0309
PLUS FRACTURE HEAD PROSTHESIS
K
98
4585
OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE
K
98
4028
THE NEW BIO-MOORE ENDO HEADS
K
98
1451
ARGOMEDICAL BIPOLAR SYSTEM
K
97
4807
OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM
K
97
3614
FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES
K
96
5198
ULTIMA TPS CEMENTED STEM
K
96
5156
ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES
K
96
2646
PRIME MODULAR ENDO HEAD
K
96
0538
OPTEON UNIPOLAR
K
95
5385
JOHNSON & JOHNSON AUSTIN MOORE STEM
K
95
4534
OSTEONICS UNIPOLAR ENDO HEAD
K
95
4077
UNITRAX V40 MODULAR ADAPTOR
K
94
3778
OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
K
95
0563
ULTIMA AUGMENTED UHMWPE CUP
K
95
1355
LINK SADDLE PROTHESIS
K
93
1753
CORIN THOMPSON PROSTHESIS, MODIFICATION
K
93
1752
CORIN AUSTIN-MOORE PROSTHESIS, MODIFICATION
K
94
0190
ULTIMA UNIPOLAR MODULAR HEAD
K
93
4353
ZIRCONIUM ALLOY UNI-POLAR HEAD
K
92
4050
TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT
K
92
6120
CONTOUR FEMORAL HIP STEM WITH POROCOAT
K
92
4379
ULTIMA(TM) TOTAL HIP SYSTEM CEMENTED FEMORAL STEM
K
92
2146
OSTRONCS HEMI-HIP STEM SERIES
K
92
0231
OMNIFIT M-HA HIP STEM SERIES
K
92
0193
OMNIFLEX M-HA HIP STEM SERIES
K
91
5868
PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT
K
90
3877
MTS FEMORAL HIP SYSTEM
K
90
2365
MODULAR UNIPOLAR SYSTEM
K
90
5334
THOMPSON TYPE HIP PROSTHESIS
K
90
5349
AUSTIN MOORE TYPE HIP PROTHESIS
K
90
4119
PROFILE COLLARED HIP PROSTHESIS
K
90
3884
KINAMED ATH 26MM COCR TOTAL HIP FEMORAL HEAD
K
90
3885
KINAMED ATH 22MM COCR TOTAL HLIP FEMORAL HEAD
K
90
3241
AUSTIN MOORE TYPE HIP PROSTHESIS
K
90
3240
THOMPSON TYPE HIS PROSTHESIS
K
89
6853
PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA
K
90
0638
P.F.C. HIP SYSTEM NON-POROUS FEMORAL COMPONENT
K
89
6105
EVOLUTION HIP SYSTEM
K
89
5886
BIOPRO HEMI-ENDO MODULAR HEAD FOR PSL SYSTEM
K
89
1482
AML(R) COLLARLESS LATERALIZED FEMORAL HIP
K
88
4889
MODIFIED O.E.C. UNIV. SELF-ALIGNING ACETA. COMP.
K
88
4789
NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI
K
88
3179
HIP FRACTURE STEM SYSTEM
K
87
4915
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS
K
87
2535
BIOPRO FEMORAL HIP COMPONENT
K
87
2776
PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT
K
87
2025
POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS
K
87
2878
TRI-LOCK MODIFIED FEMORAL PROSTHESIS
K
87
1656
ORTHOMET AUSTIN-MOORE SYSTEM
K
86
4085
BROOKER BIO-GROOVE FEMORAL COMPONENT
K
85
4791
BIO-FIT HIP SYSTEM
K
85
5228
FEMORAL HEMI-HIP PROSTHESES
K
85
3662
MUELLER CURVED STEM HEMI-PROSTHESIS
K
85
2584
POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT
K
84
4818
NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS
K
85
2420
BTM TOTAL HIP SYSTEM
K
85
0928
V.E.P. HIP -VARIABLE ENDO-PROSTHESIS
K
84
3995
TF-II HIP PROSTHESIS
K
84
5025
AUSTIN-MOORE MODULAR HIP PROSTHESIS
K
84
4488
MECRON CEMENTED STRUCTURED STEM HIP PROSTHESIS
K
84
4487
MECRON FEMORAL HEAD W/CONE AS UNIPOLAR OR BIPOLAR
K
84
4486
MECRON MRC-HEADLESS FEMORAL COMPONENT
K
84
2559
WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
K
84
2465
UNILOC
K
84
2234
NEW JERSEY FEMORAL STEM
K
84
1437
PENNSYLVANIA HOSPITAL HIP SYS
K
83
3599
MODIFIED HPS HIP PROSTHESIS
K
83
3403
BDH UNIPOLAR FEMORAL COMPONENT A2
K
83
1851
STRAIGHT STEM FEMORAL HEAD PROSTHESIS
K
83
1420
HIP PROSTHESIS -VARIOUS
K
83
0307
AUFRANC-TURNER ATS TOTAL HIP SYSTEM
K
82
3051
METAL KNEE & HIP PROSTHESIS
K
82
2321
IOI 32 TM FEMORAL COMPONENT
K
82
2320
KAMPNER FEMORAL COMPONENT
K
82
0755
THE ORIGINAL LEINBACH PLATFORM TOTAL HIP
K
82
1343
BDH FEMORAL COMPONENT
K
81
1416
MOORE HIP PROSTHESIS, PMMA COATED
K
81
1738
COLLARLESS TAPERED STEM HIP PROSTH. DEV
K
80
3191
PROSTHESIS, HIP FEMORAL COMPONENT METAL
K
80
0207
UHR UNIVERSAL6HIP REPLACEMENT
K
79
2181
3M HS 22 FEMORAL COMPONENT
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
/
KWL
/
K903877
View Source
MTS FEMORAL HIP SYSTEM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K903877
510(k) Type
Traditional
Applicant
3M COMPANY
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/18/1991
Days to Decision
149 days