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 |
|---|---|---|---|
| May 31, 2017 | K170573 | Empowr CR Knee Tibial Insert Encore Medical L.P. | JWH |
| May 22, 2017 | K170282 | Smith & Nephew VISIONAIRE Adaptive Guides Smith & Nephew, Inc. | JWH |
| May 11, 2017 | K170648 | ANTHEM CR Total Knee System Smith & Nephew, Inc. | JWH |
| Apr 28, 2017 | K171045 | Exactech® Truliant Line Extensions Exactech, Inc. | JWH |
| Apr 26, 2017 | K163332 | Apex Revision Knee System Omnilife Science | JWH |
| Mar 16, 2017 | K161705 | U2 Total Knee System E-XPE products United Orthopedic Corporation, TW | JWH |
| Mar 6, 2017 | K162035 | GMK Sphere Medacta International S.A., CH | JWH |
| Mar 1, 2017 | K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Rev Microport Orthopedics, Inc. | JWH |
| Feb 23, 2017 | K170240 | Truliant Femoral Components Exactech, Inc. | JWH |
| Feb 1, 2017 | K161360 | U2 Total Knee System, PSA Tibial Insert United Orthopedic Corporation, TW | JWH |
| Jan 19, 2017 | K161414 | Anatomic Total Knee System Amplitude, FR | JWH |
| Jan 13, 2017 | K162775 | Legion Cone System Smith & Nephew, Inc. | JWH |
| Dec 19, 2016 | K160771 | Destiknee Total Knee System Meril Healthcare Private Limited, IN | JWH |
| Dec 19, 2016 | K160515 | PS2 Knee System Consensus Orthopedics, Inc. | JWH |
| Dec 1, 2016 | K160157 | LOSPA Modular Knee System Corentec Co., Ltd., KR | JWH |
| Nov 7, 2016 | K162273 | Materialise TKA Guide System Materialise NV, BE | JWH |
| Oct 28, 2016 | K162422 | Klassic Knee System Total Joint Orthopedics, Inc. | JWH |
| Sep 23, 2016 | K161945 | EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm) Encore Medical L.P. | JWH |
| Sep 7, 2016 | K162222 | GENflex2 Total Knee System Stelkast, Inc. | JWH |
| Sep 6, 2016 | K160159 | Active-X Total Knee System Signature Orthopaedics Pty, Ltd., AU | JWH |
| Jul 15, 2016 | K161668 | ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS) Conformis, Inc. | JWH |
| Jun 14, 2016 | K161366 | ConfoMIS iTotal Cruciate Retaining (CR) Knee Replacement System (iTotal CR KRS) Conformis, Inc. | JWH |
| Jun 10, 2016 | K160700 | ATTUNE Revision Knee System Depuy(Ireland), IE | JWH |
| May 19, 2016 | K160342 | EMPOWR PS Knee System Encore Medical L.P. | JWH |
| Apr 12, 2016 | K152430 | All Poly Tibial Component United Orthopedic Corporation, TW | JWH |
| Mar 25, 2016 | K153721 | iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc. | JWH |
| Mar 25, 2016 | K153595 | Optetrak Logic Metaphyseal Cones Exactech, Inc. | JWH |
| Mar 18, 2016 | K160484 | Optetrak Advanced Patella Exactech, Inc. | JWH |
| Mar 7, 2016 | K160025 | iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System Conformis, Inc. | JWH |
| Jan 7, 2016 | K153217 | ConforMIS iTotal Posterior Stabilized Knee Replacement System Conformis, Inc. | JWH |
| Dec 21, 2015 | K153437 | Apex Revision Knee System Omnilife Science | JWH |
| Dec 17, 2015 | K153310 | Klassic Knee System Total Joint Orthopedics, Inc. | JWH |
| Nov 25, 2015 | K152494 | Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments Zimmer, Inc. | JWH |
| Nov 13, 2015 | K153075 | Klassic Knee System Total Joint Orthopedics, Inc. | JWH |
| Nov 12, 2015 | K152382 | Arthrex iBalance TKA System Arthrex, Inc. | JWH |
| Oct 29, 2015 | K152008 | Physica PS Knee System Lima Corporate S.P.A., IT | JWH |
| Oct 27, 2015 | K152169 | Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts Ortho Development Corporation | JWH |
| Oct 27, 2015 | K150241 | Genesis II XLPE Resurfacing Patellar Components Smith & Nephew, Inc. | JWH |
| Oct 21, 2015 | K152726 | JOURNEY II XR Knee System Smith & Nephew, Inc. | JWH |
| Oct 21, 2015 | K152704 | iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System Conformis, Inc. | JWH |
| Oct 6, 2015 | K151266 | Physica CR Knee System Lima Corporate S.P.A., IT | JWH |
| Sep 25, 2015 | K150829 | U2 Total Knee System- Additional Sizes United Orthopedic Corporation, TW | JWH |
| Sep 3, 2015 | K152170 | Exactech Optetrak Logic Enhanced Assembly Exactech, Inc. | JWH |
| Aug 10, 2015 | K150928 | Materialise TKA Guide System, Materialise TKA Planner, Materialise TKA Guides Materialise NV, BE | JWH |
| Jun 23, 2015 | K150783 | Progressive Orthopaedic Total Knee System The Progressive Orthopaedic Company, LLC | JWH |
| Jun 12, 2015 | K150496 | Total Knee Arthroplasty System Responsive Orthopedics, LLC | JWH |
| May 29, 2015 | K150890 | Exactech Optetrak Logic CC Exactech, Inc. | JWH |
| May 29, 2015 | K150544 | Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System Aesculap Implant Systems, LLC | JWH |
| May 15, 2015 | K143242 | Rebel 3DKNEE System Encore Medical L.P. | JWH |
| Apr 2, 2015 | K141934 | PHYSICA KR KNEE SYSTEM Lima Corporate S.P.A., IT | JWH |
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