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
2005-11-22
JWH
2005-10-17
PROVEN REVISION MODULAR TIBIAL TRAY
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JWH
2005-10-12
SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS
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JWH
2005-07-27
MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ
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JWH
2005-07-20
PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT
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JWH
2005-07-19
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
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JWH
2005-07-13
TRIATHLON KNEE SYSTEM
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JWH
2005-04-20
MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS
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JWH
2005-03-29
SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT
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JWH
2005-03-14
SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE
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JWH
2005-03-11
SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT
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JWH
2005-03-07
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
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JWH
2005-02-18
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
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JWH
2005-02-11
VANGUARD SSK KNEE SYSTEM
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JWH
2005-02-09
SCORPIO NRG KNEE SYSTEM
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JWH
2005-01-12
TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT
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JWH
2004-12-07
AEQUOS
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JWH
2004-11-23
SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT
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JWH
2004-10-13
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES
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JWH
2004-09-30
TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ
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JWH
2004-09-23
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
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JWH
2004-07-22
LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY
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JWH
2004-07-09
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
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JWH
2004-07-01
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)
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JWH
2004-07-01
REVISION KNEE SYSTEM
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JWH
2004-07-01
LPS
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JWH
2004-05-28
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
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JWH
2004-05-28
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
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JWH
2004-05-21
MAXIM ACCEL (VANGUARD) PS+ BEARINGS
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JWH
2004-05-05
TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE
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JWH
2004-04-22
VANGUARD PATELLA COMPONENTS
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JWH
2004-02-23
DEPUY SIGMA XLK TIBIAL INSERTS
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JWH
2004-02-13
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI
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JWH
2004-02-05
DEPUY SIGMA TIBIAL INSERTS
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JWH
2004-01-15
ADVANCE DOUBLE HIGH INSERT
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JWH
2004-01-15
SCORPIO KNEE SYSTEM - TIBIAL INSERTS
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JWH
2004-01-08
NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS
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JWH
2003-12-19
GEM INSET PATELLAR COMPONENT
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JWH
2003-12-10
SCORPIO LOW PROFILE TIBIAL TRAY
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JWH
2003-11-20
SCORPIO NRG KNEE SYSTEM
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JWH
2003-10-10
PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT
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JWH
2003-10-02
HLS NOETOS SYSTEM
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JWH
2003-09-26
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
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JWH
2003-09-23
OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS
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JWH
2003-09-04
HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS
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JWH
2003-09-02
TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM
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JWH
2003-08-21
GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT
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JWH
2003-08-21
COLUMBUS (PS)
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JWH
2003-08-08
VKS/TC-PLUS REVISION KNEE
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JWH
2003-07-15
ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM
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JWH
2003-07-14
TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
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JWH
2003-04-02
OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT
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JWH
2003-03-25
PROVEN MODULAR TIBIAL TRAY
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JWH
2003-02-25
UNICONDYLAR FEMORAL COMPONENT
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JWH
2003-02-03
DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT
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JWH
2003-01-17
MAXIM ACCEL KNEE SYSTEM
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JWH
2003-01-17
NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE
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JWH
2003-01-15
NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS
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JWH
2002-12-30
NARROW ASCENT INTERLOK FEMORAL COMPONENTS
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JWH
2002-12-13
COLUMBUS (CR) TOTAL KNEE SYSTEM
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JWH
2002-11-13
SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING
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JWH
2002-11-08
MODIFICATION TO VKS KNEE SYSTEM
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JWH
2002-11-08
COLUMBUS TOTAL KNEE SYSTEM (CR)
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JWH
2002-10-18
VKS KNEE SYSTEM
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JWH
2002-10-18
DURACON CS TIBIAL INSERT
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JWH
2002-10-17
NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
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JWH
2002-10-17
OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY
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JWH
2002-09-23
TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
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JWH
2002-08-19
TOTAL KNEE FEMORAL COMPONENT
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JWH
2002-08-15
ANTERIOR STABILIZED TIBIAL BEARINGS
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JWH
2002-08-12
UKNEE TOTAL KNEE SYSTEM
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JWH
2002-08-09
NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE
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JWH
2002-07-22
SEARCH EVOLUTION TOTAL KNEE SYSTEM
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JWH
2002-07-17
HLS NOETOS SYSTEM
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JWH
2002-07-12
3D KNEE
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JWH
2002-07-09
PROVEN MODULAR POSTERIOR STABILIZED FEMORAL
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JWH
2002-06-06
SCORPIO INSET PATELLAR COMPONENT
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JWH
2002-06-05
ASCENT ALL-POLY PS TIBIAL BEARINGS
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JWH
2002-05-06
ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED
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JWH
2002-03-15
VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS
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JWH
2002-02-26
MEDIAL ROTATION KNEE SYSTEM
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JWH
2002-02-12
NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0
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JWH
2002-01-30
BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1
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JWH
2001-12-27
PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
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JWH
2001-11-16
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT
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JWH
2001-10-10
DURACON PS LIPPED TIBIAL INSERT
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JWH
2001-09-26
THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0
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JWH
2001-08-15
MAXIM RPG PS FEMORAL COMPONENT
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JWH
2001-07-31
OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES
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JWH
2001-07-26
THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX)
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JWH
2001-07-19
NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)
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JWH
2001-07-16
OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
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JWH
2001-06-28
SCORPIO CR SUPERFLEX TIBIAL INSERT
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JWH
2001-06-27
ORTHOGENESIS LPS SYSTEM
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JWH
2001-06-19
PFC SIGMA LUGGED TIBIAL TRAY
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JWH
2001-05-24
TC-PLUS POROUS TIBIAL COMPONENTS
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JWH
2001-05-24
TC-PLUS POROUS FEMORAL COMPONENTS
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JWH
2001-05-18
ASCENT KNEE SYSTEM
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JWH
2001-05-17
GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
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JWH
2001-03-19
NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
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