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 |
|---|---|---|---|
| Jul 13, 2021 | K211938 | Physica LMC Knee System Limacorporate, IT | JWH |
| May 18, 2021 | K210829 | Persona Revision Knee System Femoral Metaphyseal Cones Zimmer, Inc. | JWH |
| May 13, 2021 | K211004 | GMK Spherika Femurs and Fixed Tibial Trays Plus Medacta International S.A., CH | JWH |
| May 13, 2021 | K202924 | LinkSymphoKnee System Waldemar Link GmbH & Co. KG, DE | JWH |
| May 12, 2021 | K210809 | iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS) Conformis, Inc. | JWH |
| May 6, 2021 | K210191 | Identity Imprint Knee Replacement System Conformis, Inc. | JWH |
| May 5, 2021 | K200765 | Genius / Genuin Total Knee System Biorad Medisys Pvt, Ltd., IN | JWH |
| Apr 21, 2021 | K210961 | U2 Total Knee System, XPE Tibial Insert, PS PLUS United Orthopedic Corporation, TW | JWH |
| Apr 21, 2021 | K210483 | MOBIO Total Knee System B-One Ortho, Corp. | JWH |
| Apr 2, 2021 | K201611 | Apex Knee System Omnilife Science | JWH |
| Mar 18, 2021 | K210551 | Persona Revision Knee System Zimmer, Inc. | JWH |
| Feb 17, 2021 | K210252 | iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replace Conformis, Inc. | JWH |
| Dec 28, 2020 | K202248 | Attune Revision Sleeve LPS Femoral Adaptors Depuy Ireland UC, IE | JWH |
| Dec 22, 2020 | K203447 | iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Re Conformis, Inc. | JWH |
| Dec 11, 2020 | K202684 | GMK Total Knee System - TiNbN Coating Medacta International S.A., CH | JWH |
| Nov 18, 2020 | K200912 | Freedom(R) - TiNbN Coated Knee Maxx Orthopedics, Inc. | JWH |
| Oct 23, 2020 | K202429 | Mobio Total Knee System B-One Ortho, Corp. | JWH |
| Oct 9, 2020 | K202740 | Klassic Knee System Tibial Inserts, PS-Max Total Joint Orthopedics, Inc. | JWH |
| Sep 18, 2020 | K202022 | GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UH Medacta International S.A., CH | JWH |
| Jul 30, 2020 | K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - Right Corentec Co., Ltd., KR | JWH |
| Jul 10, 2020 | K201343 | Triathlon Total KneeSystem Howmedica Osteonics Corp., Dba Stryker Orthopaedics | JWH |
| Jun 16, 2020 | K201023 | iTotal® Identity Posterior Stabilized Knee Replacement System Conformis, Inc. | JWH |
| Jun 16, 2020 | K193540 | TRUMATCH Personalized Solutions DePuy Orthopaedics, Inc. | JWH |
| Jun 4, 2020 | K200227 | Journey II XR Knee Instrument Smith & Nephew, Inc. | JWH |
| May 7, 2020 | K200653 | AMF Revision TT Cones Lima Corporate S.P.A., IT | JWH |
| May 7, 2020 | K200395 | LOSPA II Knee System (EXULT Knee Replacement System) Corentec Co., Ltd., KR | JWH |
| Apr 24, 2020 | K200826 | Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks Smith & Nephew, Inc. | JWH |
| Mar 24, 2020 | K200209 | Persona Personalized Knee System Zimmer, Inc. | JWH |
| Mar 13, 2020 | K200407 | LEGION Inserts with JRNY Lock Smith & Nephew, Inc. | JWH |
| Mar 13, 2020 | K200075 | 3DMetal Diaphyseal Femoral Cones Medacta International S.A., CH | JWH |
| Mar 13, 2020 | K193105 | iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iT Conformis, Inc. | JWH |
| Jan 31, 2020 | K193284 | Physica LMC Knee System Lima Corporate S.P.A., IT | JWH |
| Jan 30, 2020 | K193057 | ATTUNE All-Polyethylene Tibia Depuy Ireland UC, IE | JWH |
| Jan 24, 2020 | K193223 | Persona Personalized Knee System Zimmer, Inc. | JWH |
| Dec 11, 2019 | K192507 | LOSPA II Knee System Corentec Co., Ltd., KR | JWH |
| Nov 27, 2019 | K190577 | World Knee Total Knee Systems Signature Orthopaedics Pty, Ltd., AU | JWH |
| Nov 26, 2019 | K190911 | Physica KR Liner and SMR Reverse Humeral Liner Limacorporate, IT | JWH |
| Nov 8, 2019 | K182301 | PFC SIGMA Knee System DePuy Orthopaedics, Inc. | JWH |
| Oct 22, 2019 | K192084 | Madison Total Knee System Implanet, S.A., FR | JWH |
| Sep 25, 2019 | K191765 | OMNI TiN Coated Apex Knee System Omni Life Science, Inc. | JWH |
| Sep 5, 2019 | K192148 | Freedom Primary PCK Maxx Orthopedics, Inc. | JWH |
| Sep 5, 2019 | K191625 | Persona Revision Knee System Zimmer, Inc. | JWH |
| Aug 22, 2019 | K190402 | Triathlon Total Knee System-Additional Components Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | JWH |
| Aug 8, 2019 | K190562 | iTotal Identity Cruciate Retaining Knee Replacement System Conformis, Inc. | JWH |
| Aug 1, 2019 | K191192 | SurgTech GENOLL Total Knee System Surgtech, Inc. | JWH |
| Jul 25, 2019 | K183017 | Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer Osteoremedies, LLC | JWH |
| Jul 18, 2019 | K191755 | SPAR-K Instruments (for use with Gemini SL Total Knee System) Waldemar Link GmbH & Co. KG, DE | JWH |
| Jun 20, 2019 | K190122 | Renovis A200 PS Knee System as part of the Renovis A200 Knee System Renovis Surgical Technologies | JWH |
| Jun 4, 2019 | K190068 | Vanguard XP Knee System Zimmer, Inc. | JWH |
| Jun 4, 2019 | K183533 | Unity Total Knee System Corin U.S.A. Limited | JWH |
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