JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Class II
FDA Device Classification
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 |
|---|
| 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 |
| K243817 | howmedica osteonics corp., dba stryker orthopaedics | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Po | February 6, 2025 |
| K241180 | shalby advanced technologies | Consensus Knee System with TiNbN | January 14, 2025 |