# K031901: Proven Revision Femoral and Proven Revision Tibial Insert

- Pathway: 510(k) (Special)
- Applicant: Stelkast Company
- Decided: Oct 10, 2003 after 112 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: 1 generation back to K980276 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980276: Stelkast Proven Cemented, Semi-Constrained Total Knee System, Stelkast Company (1998) Summary page 3.

## Indications for use
1. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. 2. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. 3. For cemented use only.

Source page: https://510kreport.com/device/K031901
Methodology: https://510kreport.com/methodology