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 22, 1985 | K851231 | RMC POSTERIOR STABILIZED KNEE SYSTEM Richards Medical Co., Inc. | JWH |
| Jan 10, 1985 | K843907 | POROUS COATED TITANIUM KNEE PROSTHES- Johnson & Johnson Professionals, Inc. | JWH |
| Sep 26, 1984 | K843242 | TRICON M TIBIAL COMPONENT Richards Medical Co., Inc. | JWH |
| Sep 26, 1984 | K843241 | TRICON-P TIBIAL COMPONENT Richards Medical Co., Inc. | JWH |
| Apr 11, 1984 | K834432 | ANTHRO-MODULAR TOTAL KNEE Zimmer, Inc. | JWH |
| Feb 13, 1984 | K833363 | CLOUTIER II FIBER METAL TOTAL KNEE Zimmer, Inc. | JWH |
| Feb 9, 1984 | K840100 | PATELLA PROSTHESIS Techmedica, Inc. | JWH |
| Jan 31, 1984 | K833921 | AGC TOTAL KNEE PROSTHESIS Biomet, Inc. | JWH |
| Dec 22, 1983 | K833411 | KNEE PROSTHESIS-PATELLA COMPONENT Johnson & Johnson Professionals, Inc. | JWH |
| Jul 19, 1983 | K830927 | KNEE PROSTHESIS-TIBIAL COMPONENT Johnson & Johnson Professionals, Inc. | JWH |
| Apr 26, 1983 | K830121 | INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE Zimmer, Inc. | JWH |
| Feb 10, 1982 | K813598 | 101 TOTAL CONDYLAR KNEE SYSTEM Intermedics Orthopedics | JWH |
| Apr 8, 1981 | K810328 | BIO CONDYLAR TM KNEE Depuy, Inc. | JWH |
| Mar 11, 1981 | K810326 | POROCOAT TM TOWNLEY ANATOMIC KNEE Depuy, Inc. | JWH |
| Dec 17, 1980 | K802922 | POROUS COATED ANATOMICAL-TOTAL KNEE Howmedica Corp. | JWH |
| May 6, 1980 | K792089 | THE HOWMEDICA KINEMATIC KNEE SYSTEM Howmedica Corp. | JWH |
| May 8, 1979 | K790219 | PROTHESIS, RETAINED GEOMETRIC KNEE Zimmer, Inc. | JWH |
| Aug 14, 1978 | K781294 | PROSTHESIS, KNEE, TOTAL Biomet, Inc. | JWH |
| Dec 8, 1977 | K772225 | PATELLAR PROSTHESIS Cutter Laboratories, Inc. | JWH |
| Aug 26, 1977 | K771598 | PATELLA PROSTHESIS/TRAIL COMPONENT Depuy, Inc. | JWH |
| Jul 20, 1976 | K760200 | PROSTHESIS, PATELLAR ARTICULAR SURFACE Depuy, Inc. | JWH |
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