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 |
|---|---|---|---|
| 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 |
| K251717 | maxx orthopedics | Freedom® Total Knee System Titanium Tibial Base Plate | June 26, 2025 |
| K242410 | nextstep arthropedix | NextStep Arthropedix Total Knee System | May 8, 2025 |
| K250889 | corentec co | EXULT Knee Replacement System | April 17, 2025 |
| K250677 | smith and nephew | LEGION Total Knee System | April 2, 2025 |
| K243991 | total joint othopedics | Klassic Knee System - Revision Tibial Baseplate | March 24, 2025 |
| K250382 | maxx orthopedics | Freedom Total Knee System (All-poly Tibial Plate) | March 13, 2025 |
| K243724 | zimmer | Persona® Revision Knee System (Persona Revision SoluTion Femoral Components) | March 6, 2025 |
| K244039 | suzhou microport orthorecon co | MedalOne Total Knee System | February 28, 2025 |
| K243574 | microport orthopedics | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Techniqu | February 18, 2025 |