510(k) clearance
SK Knee System
- 510(k) number
- K253961
- Applicant
- Just Medical Devices (Tianjin) Co., Ltd.
- Decision date
- Sep 1, 2026
- Date received
- Dec 10, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- JWH
- Device type
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II
- Regulation
- 21 CFR 888.3560
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- Tianjin, CN