SK Knee System— 510(k) K253961

Name: FDA 510(k) clearance K253961
Creator: U.S. Food and Drug Administration
Published: 2026-09-01

Substantially Equivalent

Just Medical Devices (Tianjin) Co., Ltd.

FDA 510(k) clearance K253961 for SK Knee System, Substantially Equivalent on 2026-09-01. Applicant: Just Medical Devices (Tianjin) Co., Ltd.. Device class: 2.

Summary

SK Knee System comes from Just Medical Devices (Tianjin) Co., Ltd. under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer). The record gives no component list or sizes.

Class II, 21 CFR 888.3560. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k), decided Substantially Equivalent.

The company filed from Tianjin, China. The decision came 265 calendar days after receipt (December 10, 2025 to September 1, 2026).

Clearance details

Applicant: Just Medical Devices (Tianjin) Co., Ltd.
Product code: Product code JWH
Device class: Class 2
Regulation: 21 CFR 888.3560
Advisory panel: Orthopedic
Date received: 2025-12-10
Decision date: 2026-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tianjin, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWH

view all

K263065 — MicroPort Total Knee System2026-10-29
K262057 — GMK Extension2026-09-15
K260063 — GSPE Spacer2026-09-11
K262293 — EVOLUTION MPX Total Knee System2026-09-10
K262341 — b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem Extensions2026-09-08

Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.