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 |
|---|---|---|---|
| Mar 10, 1999 | K981996 | TITANIUM FEMORAL COMPONENT Biomet, Inc. | JWH |
| Mar 5, 1999 | K984623 | MAXIM REMOVABLE MOLDED POLY TIBIA Biomet, Inc. | JWH |
| Feb 3, 1999 | K990030 | ADVANCED REVISION PRODUCT LINE EXTENSION Wrightmedicaltechnologyinc | JWH |
| Feb 1, 1999 | K984291 | CONTINUUM KNEE SYSTEM COBALT CHROMIUM ALLOY TIBIAL COMPONENT Implex Corp. | JWH |
| Jan 28, 1999 | K984158 | P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY Depuy, Inc. | JWH |
| Dec 18, 1998 | K983733 | SULZER ORTHOPEDICS APOLLO REVISION/CONSTRAINED KNEE TIBIAL BASEPLATE STEM PLUGS Sulzer Orthopedics, Inc. | JWH |
| Dec 16, 1998 | K980925 | DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION Howmedica Corp. | JWH |
| Dec 16, 1998 | K980637 | IMPLEX CONTINUUM KNEE UNITY TIBIAL COMPONENT Implex Corp. | JWH |
| Dec 11, 1998 | K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION Howmedica Corp. | JWH |
| Dec 4, 1998 | K983153 | NATURAL-KNEE II POSTERIOR STABILIZED (P.S.) CONDYLAR KNEE TIBIAL INSERTS Sulzer Orthopedics, Inc. | JWH |
| Nov 25, 1998 | K983004 | CONSENSUS FEMORAL COMPONENT, POROUS, COCR/TI Hayes Medical, Inc. | JWH |
| Nov 6, 1998 | K980999 | ST LEGER CEMENTED SEMI-CONSTRAINED TOTAL KNEE IMPLANT Instrument Makar, Inc. | JWH |
| Oct 21, 1998 | K982903 | SULZER ORTHOPEDICS FLUTED STEMS Sulzer Orthopedics, Inc. | JWH |
| Oct 5, 1998 | K982585 | DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM DePuy Orthopaedics, Inc. | JWH |
| Sep 22, 1998 | K982869 | ASCENT SYSTEM Biomet, Inc. | JWH |
| Jul 31, 1998 | K982302 | IMPLEX CONTINUUM KNEE - HEDROCEL TIBIAL SPACERS Implex Corp. | JWH |
| Jun 18, 1998 | K974843 | DURACON(R) SMALL STABILIZER TIBIAL INSERT Howmedica Corp. | JWH |
| Jun 8, 1998 | K981560 | IMPLEX CONTINUUM KNEE SYSTEM: POROUS TIBIAL COMPONENT MODEL NUMBER 05-230 SYSTEM Implex Corp. | JWH |
| May 22, 1998 | K980781 | IMPLEX CONTINUUM KNEE- HEDROCEL REVISION FEMORAL SPACERS Implex Corp. | JWH |
| May 22, 1998 | K980713 | FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM Howmedica Corp. | JWH |
| Apr 29, 1998 | K980545 | THE NUFFIELD TOTAL KNEE SYSTEM Corin USA | JWH |
| Apr 24, 1998 | K980276 | STELKAST PROVEN CEMENTED, SEMI-CONSTRAINED TOTAL KNEE SYSTEM Stelkast Company | JWH |
| Feb 27, 1998 | K974556 | OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM Osteonics Corp. | JWH |
| Jan 30, 1998 | K974328 | ADVANCE TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc | JWH |
| Jan 21, 1998 | K972643 | DEPUY AMK 3 PEG PATELLA Depuy, Inc. | JWH |
| Jan 16, 1998 | K972967 | OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT;OSTEONICS SCORPIO TOTAL KNEE RECESSED PATELLAR COMPONENT Osteonics Corp. | JWH |
| Dec 19, 1997 | K973595 | THE POSTERIOR STABILISED NUFFIELD TOTAL KNEE SYSTEM Corin USA | JWH |
| Dec 18, 1997 | K973672 | FOUNDATION PLASMA SPRAYED METAL-BACKED PATELLA Encore Orthopedics, Inc. | JWH |
| Dec 12, 1997 | K973524 | ADVANCE MODULAR TIBIAL COMPONENT Wrightmedicaltechnologyinc | JWH |
| Dec 8, 1997 | K973412 | NATURAL-KNEE II CONSTRAINED KNEE SYSTEM Sulzer Orthopedics, Inc. | JWH |
| Dec 8, 1997 | K973406 | OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT Osteonics Corp. | JWH |
| Nov 24, 1997 | K972270 | NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT Zimmer, Inc. | JWH |
| Nov 20, 1997 | K973164 | HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS Howmedica Corp. | JWH |
| Nov 18, 1997 | K973121 | INTERAX TOTAL KNEE SYSTEM Howmedica Corp. | JWH |
| Oct 29, 1997 | K972864 | DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS Howmedica Corp. | JWH |
| Oct 29, 1997 | K972863 | DURATION STABILIZED UHMWPE KNEE COMPONENTS Howmedica Corp. | JWH |
| Oct 21, 1997 | K972770 | ADVANCE ULTRA-CONGRUENT TIBIAL INSERT Wrightmedicaltechnologyinc | JWH |
| Oct 21, 1997 | K972752 | DURACON CONVERSION METAL BACKED PATELLA Howmedica Corp. | JWH |
| Oct 1, 1997 | K972501 | APOLLO REVISION/CONSTRAINED KNEE SYSTEM Sulzer Orthopedics, Inc. | JWH |
| Sep 29, 1997 | K972626 | ADVANCE KNEE SYSTEM Wrightmedicaltechnologyinc | JWH |
| Jul 31, 1997 | K971770 | APOLLO KNEE FEMORAL SPACERS Sulzer Orthopedics, Inc. | JWH |
| Jul 24, 1997 | K971789 | IMPLEX CONTINUUM POROUS PATELLAR Implex Corp. | JWH |
| Jul 17, 1997 | K971189 | P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) Johnson & Johnson Professionals, Inc. | JWH |
| Jul 16, 1997 | K971652 | P.F.C. SIGMA INSET PATELLA Johnson & Johnson Professionals, Inc. | JWH |
| Jul 8, 1997 | K971550 | KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS Howmedica Corp. | JWH |
| Jun 11, 1997 | K965173 | DURATION STABILIZED UHMWPE KNEE COMPONENTS Howmedica Corp. | JWH |
| May 22, 1997 | K970758 | DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE Howmedica Corp. | JWH |
| Apr 30, 1997 | K970498 | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS Intermedics Orthopedics | JWH |
| Apr 2, 1997 | K970031 | FOUNDATION KNEE SYSTEM TIBIAL COMPONENT Encore Orthopedics, Inc. | JWH |
| Mar 17, 1997 | K961021 | KIRSCHNER KNEE MODIFIED Biomet, Inc. | JWH |
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