Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
FDA product code JWH · 861 cleared devices
Class 2
Orthopedic
- Regulation
- 21 CFR 888.3560
- Review panel
- OR
- Implant
- Yes
- Life sustaining
- No
- Third party review
- No
- GMP exempt
- No
- Clearance span
- 1976-07-20 – 2026-09-15
JWH
2011-08-16
JWH
2011-08-02
UNITED U2 XPE TOTAL KNEE SYSTEM
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JWH
2011-07-28
OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT
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JWH
2011-07-13
APEX KNEE SYSTEM, APEX ALL POLY TIBIA
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JWH
2011-06-22
APEX PS KNEE SYSTEM - PS-C INSERT
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JWH
2011-05-27
GMK REVISION HYBRID LINERS
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JWH
2011-05-05
HLS KNEETEC SYSTEM
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JWH
2011-04-22
REVISION PROTHESIS
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JWH
2011-04-14
OPTERTRAK LOGIC PSC TIBIAL INSERT
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JWH
2011-03-25
APEX PS KNEE SYSTEM
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JWH
2011-03-24
BALANCED KNEE SYSTEM REVISION OFFSET TIBIA
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JWH
2011-03-24
GMK REVISION KNEE SC LINERS
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JWH
2011-03-07
SYMMETRIC TOTAL KNEE AGUMENTS
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JWH
2011-03-03
VANGUARD REMOVABLE MOLDED POLY TIBIA
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JWH
2011-02-28
VANGUARD ASYMMETRICAL PATELLAR COMPONENT
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JWH
2011-02-23
PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS
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JWH
2011-02-02
SIGNATURE PLANNER; SIGNATURE GUIDES
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JWH
2011-01-07
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM
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JWH
2011-01-07
EVOLUTION MP TOTAL KNEE SYSTEM
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JWH
2010-12-08
OPTIGEN TOTAL KNEE SYSTEM
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JWH
2010-10-22
VANGUARD 360 REVISION KNEE SYSTEM
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JWH
2010-09-29
DEPUY UNIVERSAL GRIPTION TF CONES
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JWH
2010-09-28
APEX KNEE MODULAR TIBIA SYSTEM
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JWH
2010-09-24
GMK REVISION KNEE SYSTEM
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JWH
2010-09-16
ITOTAL CR KNEE REPLACEMENT SYSTEM
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JWH
2010-08-26
JOURNEY CR KNEE SYSTEM
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JWH
2010-08-02
OPTETRAK LOGIC COMBINATION TIBIAL TRAY
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JWH
2010-07-30
VEGA KNEE SYSTEM
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JWH
2010-07-08
CARDO MEDICAL FEMORAL CEMENT RESTRICTOR, MODEL 503-MCRX
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JWH
2010-06-24
CONSENSUS REVISION KNEE SYSTEM
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JWH
2010-06-18
MOTIVATION KNEE SYSTEM
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JWH
2010-06-14
UNITED STEM, PSA TYPE
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JWH
2010-04-14
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM
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JWH
2010-04-08
MYKNEE CUTTING BLOCKS
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JWH
2010-03-05
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158
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JWH
2010-03-04
EVOLUTION MP TOTAL KNEE SYSTEM
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JWH
2010-02-05
ACTIVE KNEE TOTAL KNEE REPLACEMENT SYSTEM
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JWH
2010-01-11
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T
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JWH
2009-12-23
CARDO MEDICAL ALIGN 360 MEDIALIZED PATELLA COMPONENT
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JWH
2009-11-19
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35)
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JWH
2009-10-09
BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
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JWH
2009-09-29
JOURNEY BCS KNEE SYSTEM
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JWH
2009-09-25
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT
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JWH
2009-08-20
ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE
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JWH
2009-07-10
GMK TOTAL KNEE SYSTEM
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JWH
2009-06-04
COLUMBUS REVISION KNEE SYSTEM
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JWH
2009-04-07
FREEDOM METAL BACKED TIBIAL COMPONENT
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JWH
2009-02-20
FANNING-PAPPAS MODULAR KNEE BEARING
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JWH
2009-02-06
FREEDOM TOTAL KNEE SYSTEM
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JWH
2008-12-16
UNITED U2 TOTAL KNEE SYSTEM
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JWH
2008-11-25
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
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JWH
2008-11-18
DEPUY SIGMA CR-F FEMORAL COMPONENT
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JWH
2008-10-24
VANGUARD CR STEM HOUSINGS
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JWH
2008-10-22
EVOLIS TOTAL KNEE SYSTEM
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JWH
2008-10-17
ACCIN TOTAL KNEE SYSTEM
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JWH
2008-09-26
UNITED U2 PATELLA
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JWH
2008-09-02
OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
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JWH
2008-07-03
SYMMETRIC TOTAL KNEE SYSTEM
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JWH
2008-06-17
E-POLY TIBIAL BEARINGS
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JWH
2008-06-06
PROVEN STEM EXTENDER
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JWH
2008-05-22
SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321
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JWH
2008-05-12
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS
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JWH
2008-03-20
VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
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JWH
2008-03-07
GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
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JWH
2008-02-14
MODIFICATION TO: APEX KNEE SYSTEM
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JWH
2008-01-24
DEPUY SIGMA PS FEMORAL COMPONENTS
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JWH
2007-12-20
DEPUY LPS DISTAL FEMORAL COMPONENT
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JWH
2007-12-06
LEGION STEM WITH HOLES
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JWH
2007-11-20
TC-PLUS PRIMARY KNEE SYSTEM
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JWH
2007-11-05
REGENEREX POROUS TITANIUM SLEEVE AUGMENTS
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JWH
2007-10-15
MODIFICATION TO TRIATHLON TS KNEE SYSTEM
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JWH
2007-09-19
CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
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JWH
2007-09-14
COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY
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JWH
2007-09-06
NEXGEN PROLONG ALL-POLY PATELLA
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JWH
2007-08-21
SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE)
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JWH
2007-08-15
MODIFICATION TO SCORPIO NRG KNEE SYSTEM
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JWH
2007-08-15
EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
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JWH
2007-06-01
COLUMBUS TOTAL KNEE SYSTEM AS
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JWH
2007-06-01
TRIATHLON TS KNEE SYSTEM
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JWH
2007-03-02
DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES
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JWH
2007-01-22
TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT
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JWH
2007-01-18
MICROPLASTY TIBIAL TRAYS
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JWH
2007-01-18
PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
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JWH
2007-01-08
ENCORE KNEE SYSTEM IFU
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JWH
2006-10-13
NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL
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JWH
2006-09-25
23 MM SINGLE-PEG PATELLA COMPONENT
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JWH
2006-08-31
CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM
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JWH
2006-08-03
TRIATHLON LOW PROFILE TIBIAL TRAY
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JWH
2006-08-01
OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES
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JWH
2006-07-06
BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
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JWH
2006-06-15
APEX KNEE SYSTEM
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JWH
2006-05-26
NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT
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JWH
2006-05-25
VANGUARD REMOVABLE MOLDED POLY TIBIA
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JWH
2006-05-17
COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE
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JWH
2006-05-03
LEGION COBALT CHROME REVISION KNEE SYSTEM
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JWH
2006-04-28
NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS
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JWH
2006-03-23
DEPUY PFC SIGMA KNEE PROSTHESIS
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JWH
2006-03-01
U2 TOTAL KNEE SYSTEM
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JWH
2006-02-06
COLUMBUS (CR) TOTAL KNEE SYSTEM
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JWH
2006-01-26
TRIATHLON TOTAL KNEE SYSTEM
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