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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
K
24
2871
ATTUNE™ Revision Hinge Knee
2
Cleared 510(K)
K
24
0043
EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
2
Cleared 510(K)
K
23
3980
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
2
Cleared 510(K)
K
23
0563
EVOLUTION® Hinge Knee System
2
Cleared 510(K)
K
23
0416
Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
2
Cleared 510(K)
K
22
3069
Modular Rotating Hinge Knee Systems and Compatible Components
2
Cleared 510(K)
K
22
3528
Triathlon® Hinge Knee System
2
Cleared 510(K)
K
22
0628
LINK Endo-Model EVO Knee System
2
Cleared 510(K)
K
21
1677
ELEOS Limb Salvage System
2
Cleared 510(K)
K
21
1768
LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
2
Cleared 510(K)
K
21
0010
GMK Revision & Hinge Extension - TiNbN Coating
2
Cleared 510(K)
K
19
2798
Zimmer Segmental System
2
Cleared 510(K)
K
19
0181
Instruments for LINK MEGASYSTEM-C Family
2
Cleared 510(K)
K
19
1779
Attune Revision LPS Inserts
2
Cleared 510(K)
K
19
0100
USTAR II System
2
Cleared 510(K)
K
17
2347
GMK Hinge, GMK Revision
2
Cleared 510(K)
K
16
3311
GMK Revision Femoral Distal Augmentation
2
Cleared 510(K)
K
16
1520
ELEOS Limb Salvage System
2
Cleared 510(K)
K
15
2431
LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
2
Cleared 510(K)
K
15
1008
LINK® MEGASYSTEM-C®
2
Cleared 510(K)
K
15
1118
Smith and Nephew Legion Hinge Knee System
2
Cleared 510(K)
K
14
0900
PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
2
Cleared 510(K)
K
15
0028
Zimmer Segmental System XT Components
2
Cleared 510(K)
K
14
3179
The LINK® Endo-Model® Knee System
2
Cleared 510(K)
K
14
0898
PATIENT SPECIFIC DISTAL FEMORAL
2
Cleared 510(K)
K
14
0509
BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
2
Cleared 510(K)
K
13
3152
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
2
Cleared 510(K)
K
13
1393
MAK OSS FEMORAL KNEE COMPONENTS
2
Cleared 510(K)
K
13
0299
GMK HINGE
2
Cleared 510(K)
K
12
2015
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
2
Cleared 510(K)
K
12
1029
METS MODULAR DISTAL FEMUR
2
Cleared 510(K)
K
12
0992
METS SMILES TOTAL KNEE REPLACEMENT
2
Cleared 510(K)
K
11
0940
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
2
Cleared 510(K)
K
09
2138
JTS EXTENDEABLE IMPLANT
2
Cleared 510(K)
K
10
1815
ENDURO KNEE SYSTEM
2
Cleared 510(K)
K
09
1453
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
2
Cleared 510(K)
K
08
3779
MAK OSS KNEE FEMORAL COMPONENTS
2
Cleared 510(K)
K
08
3827
ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
2
Cleared 510(K)
K
08
1111
LEGION HINGE KNEE SYSTEM
2
Cleared 510(K)
K
08
0330
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
2
Cleared 510(K)
K
07
2367
REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR
2
Cleared 510(K)
K
07
0978
ZIMMER SEGMENTAL SYSTEM
2
Cleared 510(K)
K
06
2301
DEPUY LPS PROXIMAL TIBIAL COMPONENT
2
Cleared 510(K)
K
06
0360
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS
2
Cleared 510(K)
K
06
0131
OSS-BODIES PROXIMAL TIBIAL SLEEVE
2
Cleared 510(K)
K
05
2685
ORTHOPEDIC SALVAGE SYSTEM- OSS
2
Cleared 510(K)
K
05
1479
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
2
Cleared 510(K)
K
05
1570
AVL HINGE KNEE SYSTEM
2
Cleared 510(K)
K
04
1352
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
2
Cleared 510(K)
K
04
0749
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
2
Cleared 510(K)
K
03
1804
COMPRESS DISTAL FEMORAL REPLACEMENT
2
Cleared 510(K)
K
03
1480
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
2
Cleared 510(K)
K
02
3667
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
2
Cleared 510(K)
K
02
3087
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
2
Cleared 510(K)
K
02
1489
REPIPHYSIS LIMB SALVAGE SYSTEM
2
Cleared 510(K)
K
02
1714
RT-PLUS PE INSERT CLAMP
2
Cleared 510(K)
K
02
1260
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
2
Cleared 510(K)
K
02
0381
EXPANDABLE KNEE
2
Cleared 510(K)
K
01
3385
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
2
Cleared 510(K)
K
01
3340
RT-PLUS KNEE ADDITIONAL COMPONENTS
2
Cleared 510(K)
K
01
3035
GUARDIAN LIMB SALVAGE SYSTEM
2
Cleared 510(K)
K
01
3031
MOST OPTIONS SYSTEM
2
Cleared 510(K)
K
01
1810
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
2
Cleared 510(K)
K
00
3504
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
2
Cleared 510(K)
K
01
0774
AVL HINGE KNEE SYSTEM
2
Cleared 510(K)
K
00
2552
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
2
Cleared 510(K)
K
00
1957
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
2
Cleared 510(K)
K
00
1548
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
2
Cleared 510(K)
K
99
4207
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
2
Cleared 510(K)
K
98
2160
HINGED KNEE
2
Cleared 510(K)
K
97
2401
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
2
Cleared 510(K)
K
94
5028
FINN KNEE SYSTEM
2
Cleared 510(K)
K
91
0877
FINN KNEE PROSTHESIS
2
Cleared 510(K)
K
91
0596
DCW MODULAR DISTAL FEMORAL SYSTEM
2
Cleared 510(K)
K
89
6048
S-ROM/NOILES MARK 3
2
Cleared 510(K)
K
82
3420
KINEMATIC II KNEE SYSTEM
2
Cleared 510(K)
K
82
3115
NATURALYTE BICARBONATE DIALYSATE 4400
2
Cleared 510(K)
K
82
1476
BARD ENDO LINK INTRACONDYLAR ROTATING
2
Cleared 510(K)
K
82
1340
VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.
2
Cleared 510(K)
K
82
0995
MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS
2
Cleared 510(K)
K
81
1105
SEMI-CONSTRAINT KEE JOINT HINGE PROSTH
2
Cleared 510(K)
K
81
0520
INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL
2
Cleared 510(K)
K
78
1971
KNEE SYSTEM, QUADRAXIAL CONSTRAINED
2
Cleared 510(K)
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 16 May 2025 at 11:05 pm
OR
/
subpart-d—prosthetic-devices
/
KRO
/
K023667
View Source
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K023667
510(k) Type
Special
Applicant
PLUS ORTHOPEDICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/24/2002
Days to Decision
54 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
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
K
24
2871
ATTUNE™ Revision Hinge Knee
K
24
0043
EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
K
23
3980
ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System
K
23
0563
EVOLUTION® Hinge Knee System
K
23
0416
Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®
K
22
3069
Modular Rotating Hinge Knee Systems and Compatible Components
K
22
3528
Triathlon® Hinge Knee System
K
22
0628
LINK Endo-Model EVO Knee System
K
21
1677
ELEOS Limb Salvage System
K
21
1768
LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE
K
21
0010
GMK Revision & Hinge Extension - TiNbN Coating
K
19
2798
Zimmer Segmental System
K
19
0181
Instruments for LINK MEGASYSTEM-C Family
K
19
1779
Attune Revision LPS Inserts
K
19
0100
USTAR II System
K
17
2347
GMK Hinge, GMK Revision
K
16
3311
GMK Revision Femoral Distal Augmentation
K
16
1520
ELEOS Limb Salvage System
K
15
2431
LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating
K
15
1008
LINK® MEGASYSTEM-C®
K
15
1118
Smith and Nephew Legion Hinge Knee System
K
14
0900
PATIENT SPECIFIC SMILES TOTAL KNEE REPLACEMENT
K
15
0028
Zimmer Segmental System XT Components
K
14
3179
The LINK® Endo-Model® Knee System
K
14
0898
PATIENT SPECIFIC DISTAL FEMORAL
K
14
0509
BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE
K
13
3152
JTS EXTENDIBLE DISTAL FEMORAL IMPLANT
K
13
1393
MAK OSS FEMORAL KNEE COMPONENTS
K
13
0299
GMK HINGE
K
12
2015
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
K
12
1029
METS MODULAR DISTAL FEMUR
K
12
0992
METS SMILES TOTAL KNEE REPLACEMENT
K
11
0940
ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN
K
09
2138
JTS EXTENDEABLE IMPLANT
K
10
1815
ENDURO KNEE SYSTEM
K
09
1453
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331
K
08
3779
MAK OSS KNEE FEMORAL COMPONENTS
K
08
3827
ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES
K
08
1111
LEGION HINGE KNEE SYSTEM
K
08
0330
SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER
K
07
2367
REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR
K
07
0978
ZIMMER SEGMENTAL SYSTEM
K
06
2301
DEPUY LPS PROXIMAL TIBIAL COMPONENT
K
06
0360
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS
K
06
0131
OSS-BODIES PROXIMAL TIBIAL SLEEVE
K
05
2685
ORTHOPEDIC SALVAGE SYSTEM- OSS
K
05
1479
RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS
K
05
1570
AVL HINGE KNEE SYSTEM
K
04
1352
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
K
04
0749
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
K
03
1804
COMPRESS DISTAL FEMORAL REPLACEMENT
K
03
1480
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
K
02
3667
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
K
02
3087
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
K
02
1489
REPIPHYSIS LIMB SALVAGE SYSTEM
K
02
1714
RT-PLUS PE INSERT CLAMP
K
02
1260
REDUCED SIZE ONCOLOGY SALVAGE SYSTEM
K
02
0381
EXPANDABLE KNEE
K
01
3385
NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE
K
01
3340
RT-PLUS KNEE ADDITIONAL COMPONENTS
K
01
3035
GUARDIAN LIMB SALVAGE SYSTEM
K
01
3031
MOST OPTIONS SYSTEM
K
01
1810
ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING
K
00
3504
RT-PLUS MODULAR CEMENTED KNEE COMPONENTS
K
01
0774
AVL HINGE KNEE SYSTEM
K
00
2552
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K
00
1957
MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT
K
00
1548
MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS
K
99
4207
HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE
K
98
2160
HINGED KNEE
K
97
2401
HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS
K
94
5028
FINN KNEE SYSTEM
K
91
0877
FINN KNEE PROSTHESIS
K
91
0596
DCW MODULAR DISTAL FEMORAL SYSTEM
K
89
6048
S-ROM/NOILES MARK 3
K
82
3420
KINEMATIC II KNEE SYSTEM
K
82
3115
NATURALYTE BICARBONATE DIALYSATE 4400
K
82
1476
BARD ENDO LINK INTRACONDYLAR ROTATING
K
82
1340
VARIAXIAL CONSTRAINED TOTAL KNEE PROSTH.
K
82
0995
MAGNE-FIELD 400D OSTEO-BIO-NETIC SYS
K
81
1105
SEMI-CONSTRAINT KEE JOINT HINGE PROSTH
K
81
0520
INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL
K
78
1971
KNEE SYSTEM, QUADRAXIAL CONSTRAINED
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
/
KRO
/
K023667
View Source
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K023667
510(k) Type
Special
Applicant
PLUS ORTHOPEDICS
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
12/24/2002
Days to Decision
54 days
Submission Type
Summary