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 |
|---|---|---|---|
| K262057 | GMK Extension | Medacta International SA | 2026-09-15 |
| K260063 | GSPE Spacer | The General Hospital Corporation, d/b/a Massachusetts | 2026-09-11 |
| K262293 | EVOLUTION MPX™ Total Knee System | Suzhou Microport Orthorecon Co., Ltd. | 2026-09-10 |
| K262341 | b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions | B-One Ortho, Corp. | 2026-09-08 |
| K262130 | ATTUNE Revision Knee System | Depuy Orthopaedics, Inc. | 2026-09-04 |
| K253961 | SK Knee System | Just Medical Devices (Tianjin) Co., Ltd. | 2026-09-01 |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners) | Maxx Orthopedics, Inc. | 2026-08-07 |
| K262251 | ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) | Globus Medical, Inc. | 2026-07-31 |
| K261734 | Klassic Infection Spacer System | Total Joint Orthopedics, Inc. | 2026-07-23 |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee System | DePuy Ireland UC | 2026-06-25 |
| 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 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00192629082861 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629083004 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082991 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082984 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082977 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082960 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082953 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082946 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082939 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082922 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082915 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082908 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082892 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082885 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082878 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005419 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629082854 | EVOLUTION | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005570 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005563 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005556 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005549 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005518 | ADVANCE | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005501 | ADVANCE | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005495 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005488 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005464 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005457 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005440 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005433 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |
| 00192629005426 | ADVANCE® | Microport Orthopedics Inc. | 2026-09-18 |