# K002281: Stelkast Proven Knee System

- Pathway: 510(k) (Special)
- Applicant: Stelkast Company
- Decided: Aug 17, 2000 after 24 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Sep 24, 2004 · Not classified · Z-0496-05: Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch

## 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 integrity are present. 3. For cemented use only.

Source page: https://510kreport.com/device/K002281
Methodology: https://510kreport.com/methodology