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 10, 2003 | K031901 | PROVEN REVISION FEMORAL AND PROVEN REVISION TIBIAL INSERT Stelkast Company | JWH |
| Oct 2, 2003 | K032079 | HLS NOETOS SYSTEM Tornier, FR | JWH |
| Sep 26, 2003 | K032151 | DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS Depuy, Inc. | JWH |
| Sep 23, 2003 | K032606 | OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS Exactech, Inc. | JWH |
| Sep 4, 2003 | K032479 | HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS Howmedica Osteonics Corp. | JWH |
| Sep 2, 2003 | K031729 | TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM Howmedica Osteonics Corp. | JWH |
| Aug 21, 2003 | K032295 | GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT Smith & Nephew, Inc. | JWH |
| Aug 21, 2003 | K030367 | COLUMBUS (PS) Aesculap, Inc. | JWH |
| Aug 8, 2003 | K032215 | VKS/TC-PLUS REVISION KNEE Plus Orthopedics | JWH |
| Jul 15, 2003 | K031201 | ORTHO DEVELOPMENT BALANCED KNEE MODULAR TIBIAL SYSTEM Ortho Development Corp. | JWH |
| Jul 14, 2003 | K031183 | TIBIAL SPACER FOR THE NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE Centerpulse Orthopedics, Inc. | JWH |
| Apr 2, 2003 | K030686 | OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT Exactech, Inc. | JWH |
| Mar 25, 2003 | K030577 | PROVEN MODULAR TIBIAL TRAY Stelkast Company | JWH |
| Feb 25, 2003 | K030301 | UNICONDYLAR FEMORAL COMPONENT Smith & Nephew, Inc. | JWH |
| Feb 3, 2003 | K023724 | DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT Howmedica Osteonics Corp. | JWH |
| Jan 17, 2003 | K023546 | MAXIM ACCEL KNEE SYSTEM Biomet, Inc. | JWH |
| Jan 17, 2003 | K023528 | NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE Centerplus Orthopedics, Inc. | JWH |
| Jan 15, 2003 | K024161 | NEXGEN COMPLETE KNEE SOLUTION - TRABECULAR METAL AUGMENTS Implex Corp. | JWH |
| Dec 30, 2002 | K024037 | NARROW ASCENT INTERLOK FEMORAL COMPONENTS Biomet, Inc. | JWH |
| Dec 13, 2002 | K023788 | COLUMBUS (CR) TOTAL KNEE SYSTEM Aesculap, Inc. | JWH |
| Nov 13, 2002 | K020703 | SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING Howmedica Osteonics Corp. | JWH |
| Nov 8, 2002 | K023416 | MODIFICATION TO VKS KNEE SYSTEM Plus Orthopedics | JWH |
| Nov 8, 2002 | K022672 | COLUMBUS TOTAL KNEE SYSTEM (CR) Aesculap, Inc. | JWH |
| Oct 18, 2002 | K022204 | VKS KNEE SYSTEM Plus Orthopedics | JWH |
| Oct 18, 2002 | K021451 | DURACON CS TIBIAL INSERT Howmedica Osteonics Corp. | JWH |
| Oct 17, 2002 | K023211 | NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS Zimmer, Inc. | JWH |
| Oct 17, 2002 | K023186 | OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY Exactech, Inc. | JWH |
| Sep 23, 2002 | K021740 | TOTAL KNEE CEMENTED, SEMI-CONSTRAINED Dj Orthopedics, LLC | JWH |
| Aug 19, 2002 | K022010 | TOTAL KNEE FEMORAL COMPONENT Smith & Nephew, Inc. | JWH |
| Aug 15, 2002 | K022586 | ANTERIOR STABILIZED TIBIAL BEARINGS Biomet Orthopedics, Inc. | JWH |
| Aug 12, 2002 | K021657 | UKNEE TOTAL KNEE SYSTEM United Orthopedic Corp., TW | JWH |
| Aug 9, 2002 | K021578 | NATURAL-KNEE II SYSTEM COCR TIBIAL BASEPLATE Sulzer Orthopedics, Inc. | JWH |
| Jul 22, 2002 | K021313 | SEARCH EVOLUTION TOTAL KNEE SYSTEM Aesculap, Inc. | JWH |
| Jul 17, 2002 | K013906 | HLS NOETOS SYSTEM Tornier, FR | JWH |
| Jul 12, 2002 | K020114 | 3D KNEE Encore Orthopedics, Inc. | JWH |
| Jul 9, 2002 | K021908 | PROVEN MODULAR POSTERIOR STABILIZED FEMORAL Stelkast Company | JWH |
| Jun 6, 2002 | K020830 | SCORPIO INSET PATELLAR COMPONENT Howmedica Osteonics Corp. | JWH |
| Jun 5, 2002 | K021559 | ASCENT ALL-POLY PS TIBIAL BEARINGS Biomet, Inc. | JWH |
| May 6, 2002 | K020383 | ORTHO DEVELOPMENT BALANCED KNEE TIBIAL TRAY PEGGED Ortho Development Corp. | JWH |
| Mar 15, 2002 | K012778 | VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS Smith & Nephew, Inc. | JWH |
| Feb 26, 2002 | K020214 | MEDIAL ROTATION KNEE SYSTEM Engineering Consulting Services, Inc. | JWH |
| Feb 12, 2002 | K020295 | NEXGEN LPS TRABECULAR METAL MONOBLOCK TIBIA; ZIMMER CAT # 00-5886-XXYY, IMPLEX PART # 05-121-XXYY-0 Implex Corp. | JWH |
| Jan 30, 2002 | K012702 | BUECHEL-PAPPAS (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 Endotec, Inc. | JWH |
| Dec 27, 2001 | K013991 | PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS Zimmer, Inc. | JWH |
| Nov 16, 2001 | K012776 | DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT Howmedica Osteonics Corp. | JWH |
| Oct 10, 2001 | K012172 | DURACON PS LIPPED TIBIAL INSERT Howmedica Osteonics | JWH |
| Sep 26, 2001 | K012866 | THE NEXGEN TMT TIBIA, MODELS 00-5886-XXYY, 05-120-XXYY-0 Implex Corp. | JWH |
| Aug 15, 2001 | K012348 | MAXIM RPG PS FEMORAL COMPONENT Biomet, Inc. | JWH |
| Jul 31, 2001 | K012251 | OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES Exactech, Inc. | JWH |
| Jul 26, 2001 | K012095 | THE LPS - CONTINUUM TM HYBRID TIBIA, MODELS 32-5886-2Y-XX (ZIMMER) AND 05-119-XXYY1-0 (IMPLEX) Implex Corp. | JWH |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.