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 16, 1994 | K932858 | ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT Dow Corning Wright | JWH |
| Jan 25, 1994 | K931054 | TRICK MODULAR KNEE TIBIAL TRAY-POROUS Johnson & Johnson Orthopaedics, Inc. | JWH |
| Jan 25, 1994 | K924340 | P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT Johnson & Johnson Orthopaedics, Inc. | JWH |
| Jan 21, 1994 | K925072 | AMK LANDMARK REVISION KNEE SYSTEM Depuy, Inc. | JWH |
| Jan 7, 1994 | K925837 | AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY Depuy, Inc. | JWH |
| Nov 30, 1993 | K930228 | ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE Dow Corning Wright | JWH |
| Nov 16, 1993 | K930831 | MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS Zimmer, Inc. | JWH |
| Oct 27, 1993 | K924698 | AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY Orthomet, Inc. | JWH |
| Oct 22, 1993 | K930595 | AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY Orthomet, Inc. | JWH |
| Sep 23, 1993 | K922859 | ANATOMICAL TYPE KNEE SYSTEM Osteo Technology, Inc. | JWH |
| Sep 21, 1993 | K930554 | THE NATURAL-KNEE REVISION Intermedics Orthopedics | JWH |
| Sep 21, 1993 | K922841 | BIOPRO MODULAR TIBIAL TRAY Biopro, Inc. | JWH |
| Aug 30, 1993 | K933304 | ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED Depuy, Inc. | JWH |
| Aug 24, 1993 | K925900 | LACEY REVISION FEMORAL COMPONENT Dow Corning Wright | JWH |
| Aug 6, 1993 | K930189 | ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP Dow Corning Wright | JWH |
| Aug 3, 1993 | K930188 | ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT Dow Corning Wright | JWH |
| Aug 2, 1993 | K930190 | ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP Dow Corning Wright | JWH |
| Jul 23, 1993 | K921182 | ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT Biomet, Inc. | JWH |
| Jul 13, 1993 | K922869 | TOTAL CONDYLAT TYPE KNEE SYSTEM Osteo Technology, Inc. | JWH |
| Jun 4, 1993 | K925242 | APOLLO(TM) KNEE SYSTEM Intermedics Orthopedics | JWH |
| May 18, 1993 | K926257 | ORTHOLOC ADVANTIM THICK TIBIAL BASE COMPONENT Dow Corning Wright | JWH |
| May 5, 1993 | K915525 | WHITESIDE ORTHOLOC(R) MODULAR REVISION FEMOR COMP Dow Corning Wright | JWH |
| Mar 31, 1993 | K923443 | NATURAL-KNEE ALL-POLY TIBIA Intermedics Orthopedics | JWH |
| Mar 22, 1993 | K925901 | KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER Howmedica Corp. | JWH |
| Mar 16, 1993 | K923573 | DURACON METAL BACKED PATELLA Howmedica Corp. | JWH |
| Mar 9, 1993 | K924940 | FEMORAL & TIBIAL AUGMENT BLOCK Joint Medical Products Corp. | JWH |
| Mar 4, 1993 | K915798 | PSK POSTERIOR STABILIZED TOATAL KNEE Implantology Corp. | JWH |
| Feb 12, 1993 | K925372 | OSTEONICS(R) 700 SERIES TOTAL KNEE MOD FEMOR COMP Osteonics Corp. | JWH |
| Feb 12, 1993 | K915584 | CRK CONDYLAR RESURFACING TOTAL KNEE Implantology Corp. | JWH |
| Feb 9, 1993 | K923277 | FOUNDATION KNEE SYSTEM Encore Orthopedics, Inc. | JWH |
| Nov 9, 1992 | K923807 | P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS Johnson & Johnson International | JWH |
| Oct 20, 1992 | K923451 | AMK MODULAR POROUS COATED TITANIUM TIBIAL TRAY Depuy, Inc. | JWH |
| Sep 10, 1992 | K922734 | AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM Orthomet, Inc. | JWH |
| Sep 8, 1992 | K922048 | DURACON ALL PLASTIC TIBIAL COMPONENT Howmedica Corp. | JWH |
| Sep 8, 1992 | K921640 | KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT Howmedica Corp. | JWH |
| Sep 3, 1992 | K922620 | AMK FIXED STEM CEMENTED TIBIAL TRAY Depuy, Inc. | JWH |
| Sep 1, 1992 | K920080 | CONTINUUM KNEE SYSTEM Techmedica, Inc. | JWH |
| Aug 18, 1992 | K915512 | DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS Pfizer Hospital Products Group, Inc. | JWH |
| Aug 13, 1992 | K922285 | AGC AND MAXIM KNEE COMPONENTS WITH NTS Biomet, Inc. | JWH |
| Aug 11, 1992 | K922104 | 7000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA Osteonics Corp. | JWH |
| Aug 10, 1992 | K910992 | AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE Depuy, Inc. | JWH |
| Aug 7, 1992 | K920396 | KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM Kirschner Medical Corp. | JWH |
| Aug 3, 1992 | K920698 | FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS Orthomet, Inc. | JWH |
| Aug 3, 1992 | K920426 | PSK FEMORAL AND TIBIAL INSERT COMPONENT Orthomet, Inc. | JWH |
| May 15, 1992 | K920524 | OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION Osteonics Corp. | JWH |
| May 15, 1992 | K914565 | OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM Osteonics Corp. | JWH |
| Mar 18, 1992 | K920034 | DURACON MODULAR FEMORAL COMPONENT AND FEMORAL SPAC Pfizer Hospital Products Group, Inc. | JWH |
| Feb 18, 1992 | K914072 | CONTINUUM KNEE SYSTEM (CKS) Techmedica, Inc. | JWH |
| Feb 14, 1992 | K915192 | 7000 SERIES MODULAR TIBIAL COMPONENTS Osteonics Corp. | JWH |
| Feb 14, 1992 | K915186 | 7000 SERIES TOTAL KNEE PATELLAR COMPONENTS Osteonics Corp. | JWH |
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