Product code JWH
- Device name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Medical specialty
- Orthopedic
- Device class
- 2
- Regulation number
- 888.3560
- Review panel
- OR
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261032 | NovoKnee (SteriKnee) | NovoSource | 2026-04-27 |
| K253793 | Materialise TKA Guide System | Materialise NV | 2026-01-06 |
| K252974 | EMPOWR Knee | Encore Medical L.P. | 2025-12-19 |
| K253197 | ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors | Depuy Ireland UC | 2025-11-19 |
| K253314 | Freedom Infinia™ Total Knee System | Maxx Orthopedics, Inc. | 2025-10-29 |
| K253144 | Freedom® Total Knee System – Titan PCK Components | Maxx Orthopedics, Inc. | 2025-10-22 |
| K252725 | Stem Extension Line (U2 Total Knee System—PSA Type) | United Orthopedic Corporation | 2025-09-25 |
| K251554 | Materialise TKA Guide System | Materialise NV | 2025-07-14 |
| K251776 | EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) | Encore Medical L.P. | 2025-07-08 |
| K251241 | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) | Encore Medical L.P. | 2025-07-02 |
| K251717 | Freedom® Total Knee System – Titanium Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-06-26 |
| K242410 | NextStep Arthropedix Total Knee System | Nextstep Arthropedix | 2025-05-08 |
| K250889 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2025-04-17 |
| K250677 | LEGION Total Knee System | Smith & Nephew, Inc. | 2025-04-02 |
| K243991 | Klassic Knee System - Revision Tibial Baseplate | Total Joint Othopedics, Inc. | 2025-03-24 |
| K250382 | Freedom Total Knee System (All-poly Tibial Plate) | Maxx Orthopedics, Inc. | 2025-03-13 |
| K243724 | Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) | Zimmer, Inc. | 2025-03-06 |
| K244039 | MedalOne Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | 2025-02-28 |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Microport Orthopedics, Inc. | 2025-02-18 |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert – Cruciate Retaining Insert; Scorpio NRG T... | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-02-06 |
| K241180 | Consensus Knee System with TiNbN | Shalby Advanced Technologies | 2025-01-14 |
| K243295 | Initia Knee System | Kyocera Medical Technologies, Inc. | 2025-01-13 |
| K243024 | Cellbrick Knee Spacer | United Orthopedic Corporation | 2024-12-20 |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Jo... | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024-12-04 |
| K243277 | Freedom® Medial Congruent Liner | Maxx Orthopedics, Inc. | 2024-11-19 |
| K242984 | BKS Revision System | Ortho Development Corp. | 2024-10-25 |
| K242377 | REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component | Osteoremedies, LLC | 2024-10-02 |
| K241570 | Unity Total Knee System | Corin U.S.A. Limited | 2024-09-23 |
| K242401 | EXULT Knee Replacement System | Corentec Co., Ltd. | 2024-09-12 |
| K240683 | Rx Knee System | Signature Orthopaedics Pty, Ltd. | 2024-09-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00885556029787 | LEGION | Smith & Nephew, Inc. | 2015-09-28 |
| 00885556029701 | LEGION | Smith & Nephew, Inc. | 2015-09-28 |
| 00885556029138 | LEGION | Smith & Nephew, Inc. | 2015-09-28 |
| 07613327041125 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041460 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041453 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041446 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041439 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041422 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041415 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041408 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041392 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041156 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041149 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041132 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041118 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041101 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041095 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327041071 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036596 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036589 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036572 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036565 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036558 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036541 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036534 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036527 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036510 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 07613327036503 | Triathlon | Howmedica Osteonics Corp. | 2015-09-24 |
| 03596010554284 | JOURNEY | Smith & Nephew, Inc. | 2015-08-29 |