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 |
|---|---|---|---|
| Oct 6, 1989 | K894334 | SECOND GENERATION KNEE SYSTEM Orthomet, Inc. | JWH |
| Sep 15, 1989 | K893762 | PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT Orthomet, Inc. | JWH |
| Aug 3, 1989 | K892800 | MG II POROUS TOTAL KNEE SYSTEM Zimmer, Inc. | JWH |
| Jul 28, 1989 | K893252 | WHITESIDE ORTHOLOC M.A. TOTAL KNEE SYSTEM Dow Corning Wright | JWH |
| Jul 19, 1989 | K892394 | P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS Johnson & Johnson Professionals, Inc. | JWH |
| Jul 19, 1989 | K892366 | POROUS GENESIS STEMMED TIBIAL COMPONENT Richards Medical Co., Inc. | JWH |
| Jul 19, 1989 | K890132 | POROUS GENESIS PATELLAR AND STEMLESS TIBIAL COMP. Richards Medical Co., Inc. | JWH |
| Apr 19, 1989 | K885036 | POROUS COATED GENESIS FEMORAL COMPONENT Richards Medical Co., Inc. | JWH |
| Mar 29, 1989 | K884796 | P.F.C.(TM) MODULAR KNEE SYSTEM Johnson & Johnson Professionals, Inc. | JWH |
| Feb 8, 1989 | K882322 | CONTINUUM KNEE SYSTEM (CKS) Buckman Co., Inc. | JWH |
| Feb 1, 1989 | K884338 | LACEY POSTERIOR STABILIZED KNEE SYSTEM Dow Corning Wright | JWH |
| Jan 18, 1989 | K884410 | OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM Osteonics Corp. | JWH |
| Jan 17, 1989 | K884398 | OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS Osteonics Corp. | JWH |
| Dec 1, 1988 | K883122 | AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT Depuy, Inc. | JWH |
| Nov 9, 1988 | K883215 | KIRSCHNER TC-IV/NON POR COAT/TOTAL CONDYLAR KNEE S Kirschner Medical Corp. | JWH |
| Oct 20, 1988 | K882234 | JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS Johnson & Johnson Professionals, Inc. | JWH |
| Oct 12, 1988 | K874923 | PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE Howmedica Corp. | JWH |
| Jul 19, 1988 | K881982 | PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP Howmedica Corp. | JWH |
| Mar 10, 1988 | K874635 | OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES Osteonics Corp. | JWH |
| Feb 17, 1988 | K875201 | PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG Orthomet, Inc. | JWH |
| Jan 27, 1988 | K873602 | INTERMEDICS' NATURAL-KNEE(R) REVISION SYSTEM Intermedics Orthopedics | JWH |
| Dec 18, 1987 | K874547 | KIRSCHNER PERFORM TOTAL KNEE SYSTEM POROUS COATED Kirschner Medical Corp. | JWH |
| Oct 28, 1987 | K872379 | INSALL/BURSTEIN* II MODULAR TOTAL KNEE Zimmer, Inc. | JWH |
| Oct 23, 1987 | K873197 | AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT Depuy, Inc. | JWH |
| Oct 14, 1987 | K872134 | PLUS TOTAL KNEE SYSTEM, POLY PATELLAR BUTTON Orthomet, Inc. | JWH |
| Sep 1, 1987 | K871349 | HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT Howmedica Corp. | JWH |
| Aug 14, 1987 | K872266 | CLARIFIED APPLICA. FOR LACEY CONDYLAR TOTAL KNEE Dow Corning Wright | JWH |
| Aug 3, 1987 | K871776 | WHITESIDE ORTHOLOC II REV POST STAB TOTAL KNEE SY Dow Corning Wright | JWH |
| Jul 31, 1987 | K871146 | GUSTILO/RAND TOTAL KNEE SYSTEM (GENESIS) Richards Medical Co., Inc. | JWH |
| Jul 21, 1987 | K871585 | MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM Depuy, Inc. | JWH |
| Jul 1, 1987 | K870273 | LACEY METAL BACKED PATELLA PROSTHESIS Dow Corning Wright | JWH |
| Jun 3, 1987 | K871772 | KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY Howmedica Corp. | JWH |
| Jun 2, 1987 | K871769 | OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION) Osteonics Corp. | JWH |
| May 26, 1987 | K870730 | NOILES TOTAL KNEE PROSTHESIS Joint Medical Products Corp. | JWH |
| Apr 17, 1987 | K870702 | ADG PATELLAR COMPONENT Buckman Co., Inc. | JWH |
| Mar 6, 1987 | K864632 | P.C.A. MODULAR KNEE SYSTEM Howmedica Corp. | JWH |
| Mar 4, 1987 | K864518 | LACEY PRESS-FIT CONDYLAR TOTAL KNEE Dow Corning Wright | JWH |
| Feb 6, 1987 | K864671 | ANATOMIC MODULAR KNEE (AMK) SYSTEM Depuy, Inc. | JWH |
| Feb 4, 1987 | K864627 | WHITESIDE ORTHOLOC II METAL BACKED PATELLA Dow Corning Wright | JWH |
| Dec 19, 1986 | K863668 | OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM Osteonics Corp. | JWH |
| Dec 12, 1986 | K863667 | MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS Depuy, Inc. | JWH |
| Dec 2, 1986 | K863805 | MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME Zimmer, Inc. | JWH |
| Jul 24, 1986 | K861266 | HOWMEDICA KINEMATIC PLUS KNEE SYSTEM Howmedica Corp. | JWH |
| Mar 14, 1986 | K860654 | M.C.R. KNEE PROSTHESIS (SERIES 3000) Osteonics Corp. | JWH |
| Mar 14, 1986 | K860594 | SYNATOMIC REVISION FEMORAL PROSTHESIS Depuy, Inc. | JWH |
| Mar 13, 1986 | K855166 | THACKRAY TOTAL CONDYLAR KNEES Thackray USA | JWH |
| Feb 21, 1986 | K853991 | HOFMANN KNEE Intermedics Orthopedics | JWH |
| Feb 18, 1986 | K854883 | OMKNEE SYSTEM Orthomet, Inc. | JWH |
| Dec 9, 1985 | K853661 | MILLAR/GALANTE PRECOATED TOTAL KNEE Zimmer, Inc. | JWH |
| Jul 16, 1985 | K852059 | THE P.C.A. DOME PATELLA COMPONENT Howmedica Corp. | JWH |
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