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 24, 1997 | K964951 | KINEMAX PLUS TIBIAL SPACERS Howmedica Corp. | JWH |
| Feb 13, 1997 | K963148 | NEXGEN COMPLETE KNEE SOLUTION Zimmer, Inc. | JWH |
| Jan 2, 1997 | K963255 | PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT Smith & Nephew, Inc., Orthopaedic Div. | JWH |
| Dec 27, 1996 | K964008 | FOUNDATION KNEE SYSTEM Encore Orthopedics, Inc. | JWH |
| Dec 9, 1996 | K963796 | KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS Howmedica Corp. | JWH |
| Dec 5, 1996 | K962557 | GENESIS II ZIRCONIUM FEMORAL COMPONENT/PROFIX ZIRCONIUM FEMORAL COMPONENT Smith & Nephew Richards, Inc. | JWH |
| Dec 4, 1996 | K963709 | CEMENT-ON FEMORAL STEM Biomet, Inc. | JWH |
| Nov 27, 1996 | K960856 | KONSTRUCT PATELLAR COMPONENT Biomet, Inc. | JWH |
| Nov 14, 1996 | K963242 | DURACON POSTERIOR FEMORAL SPACER Howmedica Corp. | JWH |
| Nov 6, 1996 | K963117 | P.F.C. CRUCIATE RETAING KNEE SYSTEM Johnson & Johnson Professionals, Inc. | JWH |
| Oct 1, 1996 | K963028 | TIBIAL INSERT Encore Orthopedics, Inc. | JWH |
| Aug 23, 1996 | K962196 | NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS Zimmer, Inc. | JWH |
| Aug 14, 1996 | K962152 | OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM Osteonics Corp. | JWH |
| Aug 7, 1996 | K960976 | KINEMATIC II REPLACEMENT TIBIAL INSERTS Howmedica Corp. | JWH |
| Aug 2, 1996 | K962137 | GENESIS II CONSTRAINED SYSTEM Smith & Nephew Richards, Inc. | JWH |
| Jul 10, 1996 | K961685 | P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) Johnson & Johnson Professionals, Inc. | JWH |
| Jul 9, 1996 | K961483 | DURACON ALL POLYETHYLENE PATELLA II Howmedica Corp. | JWH |
| Jul 5, 1996 | K961482 | DURACON INSET PATELLA WITH CENTRAL PEG Howmedica Corp. | JWH |
| Jun 18, 1996 | K961379 | DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) Depuy, Inc. | JWH |
| May 22, 1996 | K954818 | CONSENSUS POSTERIOR STABILIZED KNEE U.S. Medical Products, Inc. | JWH |
| May 2, 1996 | K934695 | NATURAL-KNEE TIBIAL BASEPLATE/ALL POLY PATELLA Intermedics Orthopedics | JWH |
| Apr 26, 1996 | K960279 | NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES Zimmer, Inc. | JWH |
| Apr 26, 1996 | K953443 | CONSENSUS PCL SUBSITUTING TIBIAL INSERT U.S. Medical Products, Inc. | JWH |
| Apr 23, 1996 | K960535 | APOLLO TOTAL KNEE SYSTEM SINGLE LUG PATELLA Intermedics Orthopedics | JWH |
| Apr 1, 1996 | K952943 | CONSENSUS ALL POLY TIBIA U.S. Medical Products, Inc. | JWH |
| Mar 15, 1996 | K951185 | NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE Zimmer, Inc. | JWH |
| Mar 13, 1996 | K955884 | COORDINATE REVISION KNEE SYSTEM Depuy, Inc. | JWH |
| Mar 13, 1996 | K943025 | FREEMAN/SAMUELSON TOTAL KNEE SYSTEM Biomet, Inc. | JWH |
| Feb 26, 1996 | K954208 | OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY Exactech, Inc. | JWH |
| Feb 21, 1996 | K955421 | OSTEONICS N2/VAC PACKAGING PROCESS Osteonics Corp. | JWH |
| Feb 5, 1996 | K953274 | GENESIS POROUS TIBIAL TRAYS & REVISION KNEE SYSTEM Smith & Nephew Richards, Inc. | JWH |
| Jan 31, 1996 | K954909 | PROFIX POSTERIOR-STABILIZED KNEE SYSTEM Smith & Nephew Richards, Inc. | JWH |
| Jan 30, 1996 | K953439 | ULTRACK TOTAL KNEE SYSTEM Wrightmedicaltechnologyinc | JWH |
| Jan 26, 1996 | K954684 | DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT Depuy, Inc. | JWH |
| Jan 18, 1996 | K952830 | DARWIN KNEE SYSTEM (TC3) Johnson & Johnson Professionals, Inc. | JWH |
| Nov 21, 1995 | K954138 | DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT Howmedica Corp. | JWH |
| Sep 18, 1995 | K940861 | PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE Howmedica Corp. | JWH |
| Sep 8, 1995 | K952271 | GENESIS CONSTRAINED SYSTEM (GCS) Smith & Nephew Richards, Inc. | JWH |
| Aug 22, 1995 | K951987 | GENESIS II TOTAL KNEE SYSTEM Smith & Nephew Richards, Inc. | JWH |
| Aug 14, 1995 | K944321 | S-ROM NOILES POSTERIOR STABILIZED TOTAL KNEE SYSTEM II Joint Medical Products Corp. | JWH |
| Aug 11, 1995 | K951956 | OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES Osteonics Corp. | JWH |
| Aug 9, 1995 | K936008 | DURACON BASEPLATES Howmedica Corp. | JWH |
| Aug 8, 1995 | K946088 | GENESIS POSTERIOR STABILIZED (P/S) KNEE SYSTEM Smith & Nephew Richards, Inc. | JWH |
| Jul 17, 1995 | K951027 | DEPUY AMK CO-CR FINNED TIBIAL TRAY Depuy, Inc. | JWH |
| Jul 11, 1995 | K951655 | DURACON RECESSED PATELLA Howmedica Corp. | JWH |
| Jul 11, 1995 | K946150 | CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK) Zimmer, Inc. | JWH |
| Jun 6, 1995 | K935523 | NATURAL-KNEE(R)/APOLLO(TM) KNEE Intermedics Orthopedics | JWH |
| May 31, 1995 | K945589 | CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE U.S. Medical Products, Inc. | JWH |
| May 22, 1995 | K936159 | NATURAL-KNEE II SYSTEM Intermedics Orthopedics | JWH |
| May 22, 1995 | K935080 | INSALL-BURSTEIN II Hospital For Special Surgery | JWH |
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