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 |
|---|---|---|---|
| Mar 25, 2015 | K143443 | VEGA Knee System, Columbus Total Knee System Aesculap Implants Systems, LLC | JWH |
| Mar 24, 2015 | K142649 | Progressive Orthopedic Total Knee System The Progressive Orthopaedic Company, LLC | JWH |
| Mar 4, 2015 | K143725 | Consensus Knee System Modular Tibial Baseplate Consensus Orthopedics, Inc. | JWH |
| Feb 20, 2015 | K143635 | KINETIS Total Knee System Mako Surgical | JWH |
| Feb 17, 2015 | K150105 | Klassic Knee System-Sombrero Patella Total Joint Orthopedics, Inc. | JWH |
| Feb 12, 2015 | K143226 | Visionaire Disposable Instruments Smith & Nephew, Inc. | JWH |
| Feb 12, 2015 | K143192 | Vanguard 360 Revision Knee System Biomet, Inc. | JWH |
| Dec 23, 2014 | K142933 | Biomet Tibial trays Biomet, Inc. | JWH |
| Dec 22, 2014 | K142807 | ANTHEM PS Total Knee System Smith & Nephew, Inc. | JWH |
| Dec 22, 2014 | K142787 | Zimmer Persona Personalized Knee System Zimmer, Inc. | JWH |
| Dec 11, 2014 | K142404 | iTotal Posterior Stabilized (PS) Knee Replacement System Conformis, Inc. | JWH |
| Dec 5, 2014 | K142388 | Neo Total Knee System New Era Orthopedics, LLC | JWH |
| Dec 2, 2014 | K142069 | GMK EXTENSION Medacta International | JWH |
| Nov 21, 2014 | K143106 | VEGA Knee System Aesculap Implant Systems, LLC | JWH |
| Nov 19, 2014 | K143047 | Arthrex iBalance Patella Implant, Dome Arthrex, Inc. | JWH |
| Nov 17, 2014 | K140222 | SAIPH KNEE SYSTEM Matortho | JWH |
| Nov 14, 2014 | K142161 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Nov 14, 2014 | K141471 | JOURNEY II XR KNEE SYSTEM Smith & Nephew, Inc. | JWH |
| Nov 7, 2014 | K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments Microport Orthopedics, Inc. | JWH |
| Aug 21, 2014 | K141585 | SMITH & NEPHEW DISPOSABLE FIN PUNCH Smith & Nephew, Inc. | JWH |
| Jul 15, 2014 | K140826 | GMK SPHERE EXTENSION Medacta International | JWH |
| Jul 14, 2014 | K133919 | CONSENSUS VITALITE TIBIAL INSERT Consensus Orthopedics, Inc. | JWH |
| Jul 11, 2014 | K140830 | EXPRT REVISION KNEE Encore Medical L.P. | JWH |
| Jul 3, 2014 | K140902 | E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG Biomet, Inc. | JWH |
| Jun 30, 2014 | K140833 | ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| Jun 16, 2014 | K140073 | U2 FEMORAL COMPONENT, CR, CEMENTED United Orthopedic Corp., TW | JWH |
| May 29, 2014 | K140555 | JOURNEY II BCS CONSTRAINED INSERTS Smith & Nephew, Inc. | JWH |
| May 27, 2014 | K140423 | ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM Conformis, Inc. | JWH |
| May 22, 2014 | K140027 | ZIMMER PATIENT SPECIFIC INSTRUMENTS/ SYSTEM/PLANNER Materialise NV, BE | JWH |
| May 16, 2014 | K140942 | KLASSIC KNEE TIBIAL STEM EXTENSION Total Joint Orthopedics, Inc. | JWH |
| Mar 28, 2014 | K133560 | ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM Conformis, Inc. | JWH |
| Mar 25, 2014 | K140452 | VEGA KNEE SYSTEM Aesculap Implant Systems | JWH |
| Mar 13, 2014 | K132752 | ULTRACONGRUENT INSERT United Orthopedic Corporation, TW | JWH |
| Feb 27, 2014 | K133854 | ARTHREX IBALANCE TKA SYSTEM Arthrex, Inc. | JWH |
| Feb 25, 2014 | K133162 | ZIMMER PATIENT SPECIFIC INSTRUMENTS SYSTEM, ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLA Materialise NV, BE | JWH |
| Feb 21, 2014 | K131481 | FREEDOM PCK COMPONENTS Maxx Orthopedics, Inc. | JWH |
| Feb 18, 2014 | K133449 | KASM KNEE ARTICULATING SPACER MOLDS Ortho Development Corp. | JWH |
| Feb 4, 2014 | K133737 | ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION Zimmer, Inc. | JWH |
| Jan 15, 2014 | K131864 | U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT United Orthopedic Corporation, TW | JWH |
| Jan 9, 2014 | K133256 | ITOTAL CRUCIATE RETAINING, IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEMS, IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM Conformis, Inc. | JWH |
| Dec 20, 2013 | K133630 | GMK SHORT STEM Medacta International | JWH |
| Dec 17, 2013 | K133342 | ARTHREX IBALANCE TKA SYSTEM Arthrex, Inc. | JWH |
| Dec 11, 2013 | K130708 | SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS Smith & Nephew, Inc. | JWH |
| Oct 30, 2013 | K131116 | U2 TOTAL KNEE SYSTEM - PSA TYPE, OFFSET STEM ADAPTER United Orthopedic Corporation, TW | JWH |
| Oct 23, 2013 | K131679 | EVOLUTION MP ADAPTIVE PS TIBIAL INSERT Wrightmedicaltechnologyinc | JWH |
| Oct 11, 2013 | K132161 | OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS Exactech, Inc. | JWH |
| Oct 11, 2013 | K131337 | BALANCED KNEE SYSTEM HIGH FLEX VITAMIN E PS TIBIAL INSERT AND PATELLA Ortho Development Corp. | JWH |
| Oct 8, 2013 | K131472 | APEX KNEE MODULAR TIBIA SYSTEM Omni Life Science, Inc. | JWH |
| Oct 3, 2013 | K131368 | NEO KNEE SYSTEM Pipeline Orthopedics | JWH |
| Sep 23, 2013 | K132046 | PIPELINE KNEE SYSTEM Pipeline Orthopedics | JWH |
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