FDA cleared the SK Knee System from Just Medical Devices (Tianjin) Co., Ltd. on Sep 1, 2026 under K253961, a traditional 510(k). The device falls under product code JWH, Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, regulated at 21 CFR 888.3560 as a Class 2 device. The review panel was Orthopedic.
FDA logged the submission as received on Dec 10, 2025. The decision came 265 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Just Medical Devices (Tianjin) Co., Ltd. in the last 12 months of the tracker.