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 |
|---|---|---|---|
| Jun 15, 2006 | K060192 | APEX KNEE SYSTEM Omni Life Science, Inc. | JWH |
| May 26, 2006 | K060722 | NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT Zimmer, Inc. | JWH |
| May 25, 2006 | K060525 | VANGUARD REMOVABLE MOLDED POLY TIBIA Biomet Manufacturing Corp | JWH |
| May 17, 2006 | K053579 | COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE Aesculap, Inc. | JWH |
| May 3, 2006 | K060742 | LEGION COBALT CHROME REVISION KNEE SYSTEM Smith & Nephew, Inc. | JWH |
| Apr 28, 2006 | K060370 | NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS Zimmer, Inc. | JWH |
| Mar 23, 2006 | K060515 | DEPUY PFC SIGMA KNEE PROSTHESIS DePuy Orthopaedics, Inc. | JWH |
| Mar 1, 2006 | K051640 | U2 TOTAL KNEE SYSTEM United Orthopedic Corp., TW | JWH |
| Feb 6, 2006 | K053390 | COLUMBUS (CR) TOTAL KNEE SYSTEM Aesculap, Inc. | JWH |
| Jan 26, 2006 | K053514 | TRIATHLON TOTAL KNEE SYSTEM Stryker Orthopaedics | JWH |
| Nov 22, 2005 | K052879 | NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS Zimmer, Inc. | JWH |
| Oct 17, 2005 | K051976 | PROVEN REVISION MODULAR TIBIAL TRAY Stelkast Company | JWH |
| Oct 12, 2005 | K051977 | SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS Howmedica Osteonics Corp. | JWH |
| Jul 27, 2005 | K051756 | MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ Zimmer Trabecular | JWH |
| Jul 20, 2005 | K051229 | PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT Smith & Nephew, Inc. | JWH |
| Jul 19, 2005 | K050210 | DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES Biomet, Inc. | JWH |
| Jul 13, 2005 | K051146 | TRIATHLON KNEE SYSTEM Howmedica Osteonics Corp. | JWH |
| Apr 20, 2005 | K050723 | MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS Zimmer, Inc. | JWH |
| Mar 29, 2005 | K050539 | SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT Howmedica Osteonics Corp. | JWH |
| Mar 14, 2005 | K042515 | SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE Smith & Nephew, Inc. | JWH |
| Mar 11, 2005 | K041825 | SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT Smith & Nephew, Inc. | JWH |
| Mar 7, 2005 | K043101 | NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS Zimmer, Inc. | JWH |
| Feb 18, 2005 | K043440 | SMITH & NEPHEW, INC. REVISION KNEE SYSTEM Smith & Nephew, Inc. | JWH |
| Feb 11, 2005 | K042757 | VANGUARD SSK KNEE SYSTEM Biomet, Inc. | JWH |
| Feb 9, 2005 | K042343 | SCORPIO NRG KNEE SYSTEM Howmedica Osteonics Corp. | JWH |
| Jan 12, 2005 | K042993 | TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT Howmedica Osteonics Corp. | JWH |
| Dec 7, 2004 | K033260 | AEQUOS Aap Implantate AG, DE | JWH |
| Nov 23, 2004 | K042883 | SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT Howmedica Osteonics Corp. | JWH |
| Oct 13, 2004 | K042271 | NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES Zimmer, Inc. | JWH |
| Sep 30, 2004 | K040630 | TRABECULAR METAL FEMORAL CONE AUGMENTS, MODEL 03-125-ZZZZ Implex Corp. | JWH |
| Sep 23, 2004 | K041591 | SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS Howmedica Osteonics Corp. | JWH |
| Jul 22, 2004 | K041085 | LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY Depuy, Inc. | JWH |
| Jul 9, 2004 | K040281 | LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) DePuy Orthopaedics, Inc. | JWH |
| Jul 1, 2004 | K041466 | TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC) Biomet Manufacturing Corp | JWH |
| Jul 1, 2004 | K041106 | REVISION KNEE SYSTEM Smith & Nephew, Inc. | JWH |
| Jul 1, 2004 | K033959 | LPS Depuy, Inc. | JWH |
| May 28, 2004 | K040964 | SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS Howmedica Osteonics Corp. | JWH |
| May 28, 2004 | K032522 | TECRES SPACER-K TEMPORARY KNEE PROSTHESIS Exactech, Inc. | JWH |
| May 21, 2004 | K041046 | MAXIM ACCEL (VANGUARD) PS+ BEARINGS Biomet, Inc. | JWH |
| May 5, 2004 | K040267 | TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE Howmedica Osteonics Corp. | JWH |
| Apr 22, 2004 | K040770 | VANGUARD PATELLA COMPONENTS Biomet Manufacturing, Inc. | JWH |
| Feb 23, 2004 | K040166 | DEPUY SIGMA XLK TIBIAL INSERTS DePuy Orthopaedics, Inc. | JWH |
| Feb 13, 2004 | K033883 | OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI Exactech, Inc. | JWH |
| Feb 5, 2004 | K033272 | DEPUY SIGMA TIBIAL INSERTS DePuy Orthopaedics, Inc. | JWH |
| Jan 15, 2004 | K033890 | ADVANCE DOUBLE HIGH INSERT Wrightmedicaltechnologyinc | JWH |
| Jan 15, 2004 | K033342 | SCORPIO KNEE SYSTEM - TIBIAL INSERTS Howmedica Osteonics Corp. | JWH |
| Jan 8, 2004 | K031962 | NEXGEN TRABECULAR METAL TIBIAL CONE AUGMENTS Implex Corp. | JWH |
| Dec 19, 2003 | K032950 | GEM INSET PATELLAR COMPONENT Kinamed, Inc. | JWH |
| Dec 10, 2003 | K032829 | SCORPIO LOW PROFILE TIBIAL TRAY Howmedica Osteonics Corp. | JWH |
| Nov 20, 2003 | K030978 | SCORPIO NRG KNEE SYSTEM Howmedica Osteonics Corp. | JWH |
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