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 |
|---|---|---|---|
| May 15, 1995 | K950010 | DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED Johnson & Johnson Professionals, Inc. | JWH |
| Mar 22, 1995 | K932070 | DURACON STABILIZER FEMORAL COMPONENT AND INSERT Howmedica Corp. | JWH |
| Mar 17, 1995 | K945087 | ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE Wrightmedicaltechnologyinc | JWH |
| Mar 10, 1995 | K933494 | EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM Exactech, Inc. | JWH |
| Feb 9, 1995 | K932690 | EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY Exactech, Inc. | JWH |
| Feb 8, 1995 | K941306 | FOUNDATION KNEE AUGMENTATION BLOCKS Encore Orthopedics, Inc. | JWH |
| Feb 8, 1995 | K934381 | APOLLO KNEE TIBIAL BASEPLATE/KNEE TIBIAL INSERT Intermedics Orthopedics | JWH |
| Feb 6, 1995 | K935789 | POSTERIOR STABILIZED APOLLO KNEE SYSTEM Intermedics Orthopedics | JWH |
| Feb 1, 1995 | K941769 | KNEE PROTHESIS Joint Medical Products Corp. | JWH |
| Jan 30, 1995 | K940813 | OSTEONICS(R) SERIES 7000 TOTAL KNEE Osteonics Corp. | JWH |
| Jan 30, 1995 | K933785 | NEXT GENERATION KNEE SYSTEM Zimmer, Inc. | JWH |
| Jan 27, 1995 | K943299 | DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY Depuy, Inc. | JWH |
| Jan 27, 1995 | K933229 | APOLLO KNEE FEMORAL COMPONENT Intermedics Orthopedics | JWH |
| Jan 18, 1995 | K936274 | KIRSCHNER PERFORMANCE POSTERIOR STABILIZED TOTAL KNEE SYSTEM Kirschner Medical Corp. | JWH |
| Jan 17, 1995 | K941755 | ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT Wrightmedicaltechnologyinc | JWH |
| Jan 17, 1995 | K933610 | EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS Exactech, Inc. | JWH |
| Jan 9, 1995 | K933958 | RICHARDS TOTAL KNEE SYSTEM Smith & Nephew Richards, Inc. | JWH |
| Dec 21, 1994 | K943462 | DARWIN KNEE SYSTEM Johnson & Johnson Professionals, Inc. | JWH |
| Dec 19, 1994 | K944285 | OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS Osteonics Corp. | JWH |
| Dec 15, 1994 | K944845 | ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT Wrightmedicaltechnologyinc | JWH |
| Dec 9, 1994 | K935773 | EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT Exactech, Inc. | JWH |
| Dec 8, 1994 | K941128 | OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS Osteonics Corp. | JWH |
| Dec 6, 1994 | K931466 | PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI Johnson & Johnson Orthopaedics, Inc. | JWH |
| Nov 10, 1994 | K940713 | PCA MODULAR PRIMARY/REVISION PATELLA Howmedica Corp. | JWH |
| Nov 8, 1994 | K933539 | FOUNDATION POSTERIOR STABILIZED KNEE Encore Orthopedics, Inc. | JWH |
| Oct 20, 1994 | K935726 | EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT Exactech, Inc. | JWH |
| Oct 20, 1994 | K932776 | CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS Exactech, Inc. | JWH |
| Oct 18, 1994 | K926334 | AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER Orthomet, Inc. | JWH |
| Oct 14, 1994 | K932677 | AXIOM TOTAL KNEE SYSTEM Orthomet, Inc. | JWH |
| Oct 7, 1994 | K931960 | NUFFIELD TOTAL KNEE Turnkey Intergration USA, Inc. | JWH |
| Oct 5, 1994 | K940235 | ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT Wrightmedicaltechnologyinc | JWH |
| Oct 3, 1994 | K936037 | S-ROM NOILES CRUCIATE RETAINING KNEE Joint Medical Products Corp. | JWH |
| Sep 27, 1994 | K932837 | CONSENSUS KNEE SYSTEM - PRIMARY KNEE U.S. Medical Products, Inc. | JWH |
| Sep 7, 1994 | K936079 | ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT Exactech, Inc. | JWH |
| Sep 7, 1994 | K934166 | NUFFIELD TOTAL KNEE UHMWPE TIBIA (ONE PIECE) MODIFICATION Corin Orthopedic Products | JWH |
| Sep 7, 1994 | K932210 | ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT Dow Corning Wright | JWH |
| Sep 1, 1994 | K934620 | ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE Wrightmedicaltechnologyinc | JWH |
| Sep 1, 1994 | K933290 | ORTHOLOC ADVANTIM Wrightmedicaltechnologyinc | JWH |
| Aug 25, 1994 | K933289 | THICK TIBIAL INSERT Wrightmedicaltechnologyinc | JWH |
| Aug 5, 1994 | K933843 | LINE EXTENSION FOR KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS COATED Kirschner Medical Corp. | JWH |
| Jul 22, 1994 | K932425 | FOUNDATION MODULAR TIBIAL BASEPLATE Encore Orthopedics, Inc. | JWH |
| Jul 22, 1994 | K932246 | FOUNDATION METAL-BACKED PATELLA Encore Orthopedics, Inc. | JWH |
| Jul 18, 1994 | K931651 | NATURAL-KNEE CONGRUENT TIBIAL INSERT WITH SCREW Intermedics Orthopedics | JWH |
| Jul 13, 1994 | K934589 | KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM POROUS COATED Kirschner Medical Corp. | JWH |
| Jun 30, 1994 | K932911 | ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT Dow Corning Wright | JWH |
| Jun 6, 1994 | K933867 | UNIVERSAL INSET PATELLA Johnson & Johnson Orthopaedics, Inc. | JWH |
| Jun 3, 1994 | K935262 | P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA Johnson & Johnson Orthopaedics, Inc. | JWH |
| Jun 3, 1994 | K934354 | LACEY ALL POLYETHYLENE TIBIAL COMPONENT Dow Corning Wright | JWH |
| Feb 22, 1994 | K926228 | DURACON CRUCIFORM TIBIAL BASEPLATE Howmedica Corp. | JWH |
| Feb 22, 1994 | K924482 | HOWMEDICAL TOTAL KNEE STEM EXTENDER Howmedica Corp. | JWH |
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