510(k) K253961
K253961 is an FDA 510(k) premarket notification submitted by Just Medical Devices (Tianjin) Co., Ltd. for the device "SK Knee System". The FDA issued a decision of Substantially Equivalent on September 1, 2026. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 2026
- Date Received
- December 10, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3560
- Review Panel
- OR
- Submission Type