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)
6recalls in 12 months (984 all time)
887recalls 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 |
|---|---|---|---|
| Sep 16, 2013 | K131398 | NOVOKNEE TOTAL KNEE SYSTEM Novosource, Inc. | JWH |
| Sep 13, 2013 | K131409 | CAS PSI KNEE SYSTEM Orthosoft, Inc., CA | JWH |
| Aug 22, 2013 | K131310 | GMK FULL PE TIBIAL COMPONENTS Medacta International | JWH |
| Aug 5, 2013 | K122883 | EXP TIBIAL INSERTS AND PATELLAR COMPONENTS FOR THE PROVEN GEN-FLEX TOTAL KNEE SYSTEM Stelkast Company | JWH |
| Jul 26, 2013 | K123721 | GMK REVISION EXTENSION Medacta International | JWH |
| Jul 18, 2013 | K131467 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| May 24, 2013 | K131019 | ITOTAL CRUCIATE RETAINING (C) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| May 24, 2013 | K123692 | PIPELINE KNEE SYSTEM Pipeline Orthopedics | JWH |
| May 3, 2013 | K130084 | MILESTONE REVISION KNEE SYSTEM (MRKS) - FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, STEMS, FEMORAL & TIBIAL AUGM Tgm Medical, Inc. | JWH |
| May 3, 2013 | K123159 | SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS Smith & Nephew, Inc. | JWH |
| May 3, 2013 | K122500 | NEO PS KNEE SYSTEM Pipeline Orthopedics | JWH |
| Apr 15, 2013 | K130673 | LOSPA TOTAL KNEE REPLACEMENT SYSTEM Corentec Co., Ltd., KR | JWH |
| Apr 11, 2013 | K123339 | TK1 TOTAL KNEE SYSTEM Novosource, Inc. | JWH |
| Apr 11, 2013 | K122239 | FOUNDATION KNEE SYSTEM WITH TINBN COATING FOUNDATION PS KNEE SYSTEM WITH TINBN COATING 3DKNEE SYSTEM WITH TINBN COATING Encore Medical L.P. | JWH |
| Mar 22, 2013 | K123457 | BALANCED KNEE SYSTEM HIGH FLEX PS Ortho Development Corp. | JWH |
| Mar 20, 2013 | K123687 | OPTETRAK LOGIC POROUS FEMORAL COMPONENT Exactech, Inc. | JWH |
| Feb 22, 2013 | K130143 | PERSONA NATURAL TIBIA BASEPLATES Zimmer, Inc. | JWH |
| Feb 14, 2013 | K123166 | TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P Howmedica Osteonics Corp. | JWH |
| Feb 5, 2013 | K122183 | AUGMENT AND SCREW, PSA TYPE United Orthopedic Corp., TW | JWH |
| Jan 14, 2013 | K122870 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Jan 10, 2013 | K123342 | OPTETRAK LOGIC CRC TIBIAL INSERT Exactech, Inc. | JWH |
| Dec 20, 2012 | K122991 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Dec 20, 2012 | K122975 | GKS PRIME FLEX CR TOTAL KNEE SYSTEM Permedica | JWH |
| Dec 17, 2012 | K120955 | COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM Aesculap Implant Systems, LLC | JWH |
| Dec 5, 2012 | K121640 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM Materialise NV, BE | JWH |
| Nov 9, 2012 | K122765 | PERSONA NATURAL TIBIA BASEPLATES Zimmer, Inc. | JWH |
| Oct 26, 2012 | K122985 | COLUMBUS REVISION KNEE SYSTEM Aesculap Implant System, Inc. | JWH |
| Sep 28, 2012 | K122232 | GMK NARROW Medacta International | JWH |
| Sep 27, 2012 | K122033 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Sep 10, 2012 | K113060 | UNITY TOATAL KNEE SYSTEM Corin USA | JWH |
| Aug 13, 2012 | K121443 | JOURNEY II CR KNEE SYSTEM Smith & Nephew, Inc. | JWH |
| Jul 27, 2012 | K121879 | VEGA KNEE SYSTEM Aesculap Implant Systems | JWH |
| Jul 20, 2012 | K121835 | DOMED TRI-PEG PATELLA, HIGHLY CROSS LINKED DOMED TRI-PEG PATELLA WITH VE Encore Medical L.P. | JWH |
| Jul 20, 2012 | K121416 | GMK SPHERE Medacta International | JWH |
| Jun 29, 2012 | K111785 | FREEDOM(R) STEMMED TIBIAL COMPONENTS Maxx Orthopedics, Inc. | JWH |
| Jun 8, 2012 | K120790 | GMK - LINE EXTENSION Medacta International | JWH |
| May 31, 2012 | K121307 | OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ Exactech, Inc. | JWH |
| May 18, 2012 | K120698 | GENESIS II PS NON-MODULAR FEMORAL COMPONENT Smith & Nephew, Inc. | JWH |
| May 16, 2012 | K121149 | VANGUARD SSK 360 REVISION KNEE SYSTEM Biomet Manufacturing Corp | JWH |
| May 4, 2012 | K120507 | UNITED U2 FEMORAL COMPONENT, PS, #7 United Orthopedic Corporation, TW | JWH |
| May 3, 2012 | K121037 | LOSPA TIBIAL BASE PLATE Corentec Co., Ltd., KR | JWH |
| Apr 20, 2012 | K120313 | NEO CR KNEE SYSTEM Pipeline Orthopedics | JWH |
| Apr 19, 2012 | K120316 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Apr 2, 2012 | K113829 | ZIMMER PATIENT SPECIFIC INSTRUMENT SYSTEM ZIMMER PATIENT SPECIFIC INSTRUMENTS ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNE Materialise NV, BE | JWH |
| Mar 27, 2012 | K113369 | ZIMMER PERSONA KNEE SYSTEM Zimmer, Inc. | JWH |
| Mar 20, 2012 | K113122 | PIPELINE CR PRIMARY KNEE SYSTEM Pipeline Orthopedics | JWH |
| Feb 29, 2012 | K113550 | VANGUARD COMPLETE KNEE SYSTEM Biomet Manufacturing Corp | JWH |
| Feb 29, 2012 | K112891 | APEX REVISION KNEE SYSTEMS Omni Life Science, Inc. | JWH |
| Feb 27, 2012 | K113482 | JOURNEY II DEEP DISHED ARTICULAR INSERTS Smith & Nephew, Inc. | JWH |
| Feb 16, 2012 | K110404 | EAUM TOTAL KNEE SYSTEM Corentec Co., Ltd. | JWH |
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