# K253961: SK Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Just Medical Devices (Tianjin) Co., Ltd.
- Decided: Sep 1, 2026 after 265 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K810258 (1981). 98 ancestors in all.
No later device cites it as a predicate yet.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012)
- K183583: Vanguard Complete Knee System, Zimmer, Inc. (2019)
- K101433: Depuy Attune Knee System, DePuy Orthopaedics, Inc. (2010) Summary page 5.

## Indications for use
The SK Knee System is indicated for cemented use only as a total knee replacement in patients with a painful or disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, or a failed previous total knee joint procedure.

Source page: https://510kreport.com/device/K253961
Methodology: https://510kreport.com/methodology