JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class II
FDA product code JWH covers "Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer", a Class II medical device regulated under 21 CFR 888.3560. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JWH
- Device Class
- Class II
- Regulation Number
- 888.3560
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262057 | medacta international | GMK Extension | September 15, 2026 |
| K260063 | general hospital corporation, d/b/a massachusetts | GSPE Spacer | September 11, 2026 |
| K262293 | suzhou microport orthorecon co | EVOLUTION MPX Total Knee System | September 10, 2026 |
| K262341 | b-one ortho | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensio | September 8, 2026 |
| K262130 | depuy orthopaedics | ATTUNE Revision Knee System | September 4, 2026 |
| K253961 | just medical devices (tianjin) co | SK Knee System | September 1, 2026 |
| K261563 | maxx orthopedics | Freedom Total Knee System (E-Poly Tibial Liners) | August 7, 2026 |
| K262251 | globus medical | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert | July 31, 2026 |
| K261734 | total joint orthopedics | Klassic Infection Spacer System | July 23, 2026 |
| K261458 | depuy ireland uc | ATTUNE Total Knee System; ATTUNE Cementless Knee System | June 25, 2026 |
| K261032 | novosource | NovoKnee (SteriKnee) | April 27, 2026 |
| K253793 | materialise | Materialise TKA Guide System | January 6, 2026 |
| K252974 | encore medical l.p | EMPOWR Knee | December 19, 2025 |
| K253197 | depuy ireland uc | ATTUNE Total Knee System; ATTUNE Revision Sleeve LPS Femoral Adaptors | November 19, 2025 |
| K253314 | maxx orthopedics | Freedom Infinia Total Knee System | October 29, 2025 |
| K253144 | maxx orthopedics | Freedom® Total Knee System Titan PCK Components | October 22, 2025 |
| K252725 | united orthopedic corporation | Stem Extension Line (U2 Total Knee SystemPSA Type) | September 25, 2025 |
| K251554 | materialise | Materialise TKA Guide System | July 14, 2025 |
| K251776 | encore medical l.p | EMPOWR Revision Knee (EMPOWR Revision VVC+, e+ Tibial Insert) | July 8, 2025 |
| K251241 | encore medical l.p | EMPOWR Revision Knee (EMPOWR Revision Knee Symmetric TT Cones) | July 2, 2025 |