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)
Top companies in JWH
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer, Inc. | 51 | 304 |
| DePuy Orthopaedics, Inc. | 16 | 102 |
| Smith & Nephew, Inc. | 49 | 60 |
| Exactech, Inc. | 32 | 64 |
| Howmedica Osteonics | 32 | 61 |
| Zimmer Biomet, Inc. | 0 | 85 |
| Biomet, Inc. | 40 | 44 |
| Stryker Howmedica Osteonics | 0 | 64 |
| Conformis, Inc. | 40 | 19 |
| Encore Medical L.P. | 15 | 44 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 11, 1992 | K915132 | MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM Biomet, Inc. | JWH |
| Jan 27, 1992 | K914169 | WHITESIDE ORTHOLOC MOD.TIBIAL AUGMENTATION COMP Dow Corning Wright | JWH |
| Dec 27, 1991 | K913492 | KIRSCHNER(R) HYBRIDFIT TOTAL KNEE SYSTEM Kirschner Medical Corp. | JWH |
| Dec 16, 1991 | K914230 | AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY Orthomet, Inc. | JWH |
| Oct 25, 1991 | K911972 | FREEMAN-SAMUELSON MODULAR TOTAL KNEE REPLACEMENT Intermedics Orthopedics | JWH |
| Oct 18, 1991 | K912894 | AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT Orthomet, Inc. | JWH |
| Oct 11, 1991 | K913188 | KINEMAX PLUS TIBIAL INSERT Howmedica Corp. | JWH |
| Sep 16, 1991 | K912663 | NATURAL-KNEE ULTRA CONGRUENT TIBIAL INSERT Intermedics Orthopedics | JWH |
| Sep 10, 1991 | K910940 | ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY Depuy, Inc. | JWH |
| Aug 20, 1991 | K912266 | MODIFICATION AXIOM TOTAL KNEE SYST, PATELLAR COMP Orothmet, Inc. | JWH |
| Aug 19, 1991 | K912245 | AGC REVISION KNEE PROTHESIS Biomet, Inc. | JWH |
| Aug 13, 1991 | K912147 | OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP Osteonics Corp. | JWH |
| Jul 17, 1991 | K904448 | TOWNLEY TOTAL KNEE (TTK) Biopro, Inc. | JWH |
| Jul 1, 1991 | K911572 | MG II POROUS COBAL T-CHROME FEMORAL COMPONENT Zimmer, Inc. | JWH |
| Jun 24, 1991 | K905613 | MTS KNEE SYSTEM T & R Mfg., Inc. | JWH |
| Jun 21, 1991 | K910235 | PCA MTK II TOTAL KNEE SYSTEM Howmedica Corp. | JWH |
| Jun 19, 1991 | K910990 | OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS Osteonics Corp. | JWH |
| Jun 12, 1991 | K905810 | NOILES(TM) TOTAL KNEE PROSTHESIS, MODIFICATION Joint Medical Products Corp. | JWH |
| Jun 5, 1991 | K910989 | OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP Osteonics Corp. | JWH |
| May 23, 1991 | K911198 | TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY Orthomet, Inc. | JWH |
| May 23, 1991 | K911197 | PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM Orthomet, Inc. | JWH |
| May 23, 1991 | K910563 | P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL Johnson & Johnson Orthopaedics, Inc. | JWH |
| May 6, 1991 | K910500 | HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM Howmedica Corp. | JWH |
| Apr 1, 1991 | K904208 | KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM Howmedica Corp. | JWH |
| Feb 13, 1991 | K905076 | WHITESIDE ORTHOLOC MODULAR TIBIAL CONSTRAIN.INSERT Dow Corning Wright | JWH |
| Oct 22, 1990 | K904205 | AMK MODULAR TIBIAL WEDGE SYSTEM Depuy, Inc. | JWH |
| Oct 17, 1990 | K904300 | INSET PATELLAR COMPONENT Johnson & Johnson Orthopaedics, Inc. | JWH |
| Oct 17, 1990 | K904170 | PCA (R) TIBIAL BONE WEDGES Howmedica Corp. | JWH |
| Sep 19, 1990 | K901085 | DORR KNEE SYSTEM Intermedics Orthopedics | JWH |
| Aug 22, 1990 | K902335 | NATURAL-KNEE SYSTEM SYSTEM W/COCR/CSTI(TM) Intermedics Orthopedics | JWH |
| Aug 9, 1990 | K902246 | AMK UNIVERSAL FEMORAL COMPONENT Depuy, Inc. | JWH |
| Jul 23, 1990 | K901406 | ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED Depuy, Inc. | JWH |
| Jul 6, 1990 | K895145 | SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR Orthomet, Inc. | JWH |
| Jul 3, 1990 | K901936 | PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP Orthomet, Inc. | JWH |
| Jun 26, 1990 | K901992 | WHITESIDE ORTHOLOC MODULAR POST. STAB. KNEE SYSTEM Dow Corning Wright | JWH |
| Jun 20, 1990 | K901457 | CONTINUUM KNEE SYSTEM (CKS) Techmedica, Inc. | JWH |
| May 22, 1990 | K901338 | KIRSCHNER MODULAR TCIV TOTAL KNEE SYSTEM Kirschner Medical Corp. | JWH |
| May 4, 1990 | K892503 | NUFFIELD TOTAL KNEE Orthopedic Systems, Inc. | JWH |
| Mar 2, 1990 | K896081 | WHITESIDE ORTHOLOC MODULAR METAL-BACKED PATELLA Dow Corning Wright | JWH |
| Feb 22, 1990 | K896397 | S-ROM(TM)/NOILES(TM) MARK 5 KNEE Joint Medical Products Corp. | JWH |
| Feb 15, 1990 | K896542 | ADDITION TO THE CONTINUUM KNEE SYSTEM (CKS(TM)) Techmedica, Inc. | JWH |
| Feb 8, 1990 | K895639 | MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR Zimmer, Inc. | JWH |
| Feb 2, 1990 | K894403 | PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT Howmedica Corp. | JWH |
| Jan 31, 1990 | K894937 | SHAW KNEE MODULAR TIBIAL TRAY-POROUS Johnson & Johnson Professionals, Inc. | JWH |
| Jan 9, 1990 | K895962 | KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS Kirschner Medical Corp. | JWH |
| Jan 5, 1990 | K896045 | WHITESIDE ORTHOLOC MODULAR-C TOTAL KNEE SYSTEM Dow Corning Wright | JWH |
| Jan 4, 1990 | K896452 | KINEMAX TIBIAL STEM EXTENSION Howmedica Corp. | JWH |
| Nov 20, 1989 | K893040 | ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG Orthomet, Inc. | JWH |
| Oct 20, 1989 | K894658 | KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS Howmedica Corp. | JWH |
| Oct 17, 1989 | K894504 | WHITESIDE ORTHOLOC M.A. TIBIAL BASE Dow Corning Wright | JWH |
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