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)
6recalls in 12 months (984 all time)
887recalls 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
Oct 9, 2009K090705BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT
Ortho Development Corp.
JWH
Sep 29, 2009K091014JOURNEY BCS KNEE SYSTEM
Smith & Nephew, Inc.
JWH
Sep 25, 2009K091280FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT
Maxx Orthopedics, Inc.
JWH
Aug 20, 2009K092201ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE
Wrightmedicaltechnologyinc
JWH
Jul 10, 2009K090988GMK TOTAL KNEE SYSTEM
Medacta International S.A.
JWH
Jun 4, 2009K083772COLUMBUS REVISION KNEE SYSTEM
Aesculap Implant System, Inc.
JWH
Apr 7, 2009K090411FREEDOM METAL BACKED TIBIAL COMPONENT
Maxx Orthopedics, Inc.
JWH
Feb 20, 2009K081400FANNING-PAPPAS MODULAR KNEE BEARING
Endotec, Inc.
JWH
Feb 6, 2009K082019FREEDOM TOTAL KNEE SYSTEM
Maxx Orthopedics, Inc.
JWH
Dec 16, 2008K082424UNITED U2 TOTAL KNEE SYSTEM
United Orthopedic Corp., TW
JWH
Nov 25, 2008K082358SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
Smith & Nephew, Inc.
JWH
Nov 18, 2008K082500DEPUY SIGMA CR-F FEMORAL COMPONENT
DePuy Orthopaedics, Inc.
JWH
Oct 24, 2008K082826VANGUARD CR STEM HOUSINGS
Biomet Manufacturing Corp
JWH
Oct 22, 2008K081023EVOLIS TOTAL KNEE SYSTEM
Medacta International S.A.
JWH
Oct 17, 2008K081127ACCIN TOTAL KNEE SYSTEM
Accelerated Innovation, LLC
JWH
Sep 26, 2008K082469UNITED U2 PATELLA
United Orthopedic Corp., TW
JWH
Sep 2, 2008K082022OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++
Exactech, Inc.
JWH
Jul 3, 2008K080199SYMMETRIC TOTAL KNEE SYSTEM
Signal Medical Corporation
JWH
Jun 17, 2008K080528E-POLY TIBIAL BEARINGS
Biomet Orthopedics, Inc.
JWH
Jun 6, 2008K081458PROVEN STEM EXTENDER
Stelkast Company
JWH
May 22, 2008K062274SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321
Tecres S.P.A.
JWH
May 12, 2008K080936CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS
Conformis, Inc.
JWH
Mar 20, 2008K080204VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS
Biomet, Inc.
JWH
Mar 7, 2008K073286GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM
Zimmer, Inc.
JWH
Feb 14, 2008K073602MODIFICATION TO: APEX KNEE SYSTEM
Omnlife Science
JWH
Jan 24, 2008K073529DEPUY SIGMA PS FEMORAL COMPONENTS
DePuy Orthopaedics, Inc.
JWH
Dec 20, 2007K063686DEPUY LPS DISTAL FEMORAL COMPONENT
DePuy Orthopaedics, Inc.
JWH
Dec 6, 2007K072531LEGION STEM WITH HOLES
Smith & Nephew, Inc.
JWH
Nov 20, 2007K072858TC-PLUS PRIMARY KNEE SYSTEM
Smith & Nephew, Inc.
JWH
Nov 5, 2007K072336REGENEREX POROUS TITANIUM SLEEVE AUGMENTS
Biomet Manufacturing Corp
JWH
Oct 15, 2007K072221MODIFICATION TO TRIATHLON TS KNEE SYSTEM
Howmedica Osteonics Corp.
JWH
Sep 19, 2007K071071CROSSLINKED POLYETHYLENE ARTICULAR INSERTS
Smith & Nephew, Inc.
JWH
Sep 14, 2007K071499COLUMBUS TOTAL KNEE SYSTEM MIOS CR/PS TIBIAL TRAY
Aesculap Implant Systems, Inc.
JWH
Sep 6, 2007K072281NEXGEN PROLONG ALL-POLY PATELLA
Zimmer, Inc.
JWH
Aug 21, 2007K070981SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (PLASMAPORE)
Aesculap Implant Systems, Inc.
JWH
Aug 15, 2007K071991MODIFICATION TO SCORPIO NRG KNEE SYSTEM
Howmedica Osteonics Corp.
JWH
Aug 15, 2007K071738EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER
Exactech, Inc.
JWH
Jun 1, 2007K071220COLUMBUS TOTAL KNEE SYSTEM AS
Aesculap Implant Systems, Inc.
JWH
Jun 1, 2007K070095TRIATHLON TS KNEE SYSTEM
Howmedica Osteonics Corp.
JWH
Mar 2, 2007K063633DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES
DePuy Orthopaedics, Inc.
JWH
Jan 22, 2007K063423TRIATHLON CS (CONDYLAR STABILIZING) LIPPED INSERT
Howmedica Osteonics
JWH
Jan 18, 2007K063732MICROPLASTY TIBIAL TRAYS
Biomet Manufacturing Corp
JWH
Jan 18, 2007K063211PROVEN KNEE SYSTEM HIGH FLEXION TIBIAL INSERT
Stelkast Company
JWH
Jan 8, 2007K063406ENCORE KNEE SYSTEM IFU
Encore Medical L.P.
JWH
Oct 13, 2006K062768NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL
Zimmer, Inc.
JWH
Sep 25, 2006K06134023 MM SINGLE-PEG PATELLA COMPONENT
Biomet Manufacturing, Inc.
JWH
Aug 31, 2006K052687CONFORMIS, INC. TOTAL KNEE REPAIR SYSTEM
Conformis, Inc.
JWH
Aug 3, 2006K062037TRIATHLON LOW PROFILE TIBIAL TRAY
Howmedica Osteonics Corp.
JWH
Aug 1, 2006K061882OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES
Zimmer, Inc.
JWH
Jul 6, 2006K060569BALANCED KNEE SYSTEM MODULAR REVISION KNEE SYSTEM
Ortho Development Corp.
JWH

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