ClearanceBrief
Panels › Orthopedic › Product code JWH · Class 2

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Regulation 888.3560

14510(k)s in 12 months (921 all time)
7recalls in 12 months (985 all time)
888recalls that name a 510(k)
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Top companies in JWH

Company510(k)sRecalls
Zimmer, Inc.51304
DePuy Orthopaedics, Inc.16102
Smith & Nephew, Inc.4960
Exactech, Inc.3264
Howmedica Osteonics3261
Zimmer Biomet, Inc.085
Biomet, Inc.4044
Stryker Howmedica Osteonics064
Conformis, Inc.4019
Encore Medical L.P.1544
Decided510(k)Device and applicantCode
Jul 19, 2001K011904NEXGEN PRIMARY POROUS PATELLA, MODEL 04-211-IIII-5878-65-ZZ-(STANDARD),04-212-IIII-5878-61-ZZ-(MICRO)
Implex Corp.
JWH
Jul 16, 2001K011976OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION)
Exactech, Inc.
JWH
Jun 28, 2001K011643SCORPIO CR SUPERFLEX TIBIAL INSERT
Howmedica Osteonics Corp.
JWH
Jun 27, 2001K003182ORTHOGENESIS LPS SYSTEM
Depuy, Inc.
JWH
Jun 19, 2001K003026PFC SIGMA LUGGED TIBIAL TRAY
DePuy Orthopaedics, Inc.
JWH
May 24, 2001K011288TC-PLUS POROUS TIBIAL COMPONENTS
Plus Orthopedics
JWH
May 24, 2001K011258TC-PLUS POROUS FEMORAL COMPONENTS
Plus Orthopedics
JWH
May 18, 2001K011219ASCENT KNEE SYSTEM
Biomet, Inc.
JWH
May 17, 2001K010101GEM POSTERIOR STABILIZED TOTAL KNEE SYSTEM
Kinamed, Inc.
JWH
Mar 19, 2001K003910NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS
Zimmer, Inc.
JWH
Mar 13, 2001K010434OPTETRAK B-SERIES TOTAL KNEE SYSTEM
Exactech, Inc.
JWH
Feb 15, 2001K001147ENHANCED POLYETHYLENE KNEE PROSTHESES
Howmedica Osteonics Corp.
JWH
Jan 25, 2001K004013IMPLEX CONTINUUM KNEE SYSTEM-PATELLAR COMPONENTS, MODEL 04-XX-YYYYY
Implex Corp.
JWH
Jan 12, 2001K010027MAXIM KNEE SYSTEM
Biomet, Inc.
JWH
Nov 30, 2000K002740TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS
Smith & Nephew, Inc.
JWH
Nov 6, 2000K003296BIOMET SCK KNEE SYSTEM
Biomet, Inc.
JWH
Oct 25, 2000K002335NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
Sulzer Orthopedics, Inc.
JWH
Oct 13, 2000K000666TC-PLUS SOLUTION KNEE
Plus Orthopedics
JWH
Oct 4, 2000K002772ASCENT XXL CLOSED BOX FEMORAL COMPONENT
Biomet, Inc.
JWH
Sep 19, 2000K002735ASCENT XXL OPEN BOX FEMORAL COMPONENT
Biomet, Inc.
JWH
Sep 19, 2000K002678ASCENT KNEE SYSTEM
Biomet, Inc.
JWH
Aug 17, 2000K002281STELKAST PROVEN KNEE SYSTEM
Stelkast Company
JWH
Aug 7, 2000K001456CONSENSUS KNEE SYSTEM
Hayes Medical, Inc.
JWH
Jul 19, 2000K994214GEM KNEE SYSTEM
Kinamed, Inc.
JWH
Jun 22, 2000K000978ANATOMIC TOTAL KNEE PROSTHESIS
Biomet, Inc.
JWH
May 23, 2000K001307CONTINUUM KNEE SYSTEM-PS FEMORAL COMPONENTS- POROUS, MODEL XX-YYY-ZZZZZ
Implex Corp.
JWH
May 11, 2000K000590LATERAL PIVOT INSERT
Encore Orthopedics, Inc.
JWH
Apr 27, 2000K001010ASCENT KNEE REVISION FEMORAL STEM
Biomet, Inc.
JWH
Apr 4, 2000K000113PROVEN KNEE SYSTEM
Stelkast Company
JWH
Mar 24, 2000K994370ORTHO DEVELOPMENT BALANCED KNEE SYSTEM
Ortho Development Corp.
JWH
Mar 10, 2000K000091DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT
Howmedica Osteonics Corp.
JWH
Mar 6, 2000K994128SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM
Howmedica Osteonics Corp.
JWH
Feb 25, 2000K000232ROTAGLIDE + MODULAR KNEE SYSTEM WITH FIXED MENISCUS
Corin USA
JWH
Feb 18, 2000K994076IMPLEX HEDROCEL PS TIBIAL COMPONENT, MODEL HEDROCEL POSTERIOR STABILIZED TIBIAL COMPONENT 05-XXX-YYYYY
Implex Corp.
JWH
Dec 20, 1999K993371SADDLE SHAPED PATELLA
Wrightmedicaltechnologyinc
JWH
Dec 8, 1999K991882NEXFLEX TOTAL KNEE SYSTEM
Nexmed, Inc.
JWH
Dec 2, 1999K993692DURACON INSET PATELLA, 25MM
Howmedica Osteonics Corp.
JWH
Nov 10, 1999K991052FS 1000 KNEE SYSTEM
Renaissance Instruments, LLC
JWH
Oct 14, 1999K993159MAXIM KNEE SYSTEM
Biomet, Inc.
JWH
Oct 5, 1999K993111ASCENT KNEE SYSTEM
Biomet Manufacturing, Inc.
JWH
Aug 17, 1999K991753MAXIM REMOVABLE MOLDED POLY TIBIA
Biomet, Inc.
JWH
Jul 30, 1999K991581NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS); LPS-FLEX FIXED BEARING FEMORAL AND ARTICULAR SURFACE CO
Zimmer, Inc.
JWH
Jul 30, 1999K984054AGC V2 REVISION KNEE SYSTEM
Biomet, Inc.
JWH
Jul 28, 1999K992167PERFORMANCE KNEE SYSTEM
Biomet, Inc.
JWH
Jun 11, 1999K991143MAGNA-ROM 21 KNEE SYSTEEM
Sulzer Orthopedics, Inc.
JWH
Jun 9, 1999K991106P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY
DePuy Orthopaedics, Inc.
JWH
May 21, 1999K991428ASCENT KNEE SYSTEM
Biomet, Inc.
JWH
May 17, 1999K991461OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT
Howmedica Osteonics Corp.
JWH
May 5, 1999K972774GAS PLASMA STERILIZATION
Zimmer, Inc.
JWH
Mar 15, 1999K983835IMPLEX CONTINUUM PATELLA-REVISION HEDROCEL PATELLA
Implex Corp.
JWH

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