# K081458: Proven Stem Extender

- Pathway: 510(k) (Special)
- Applicant: Stelkast Company
- Decided: Jun 6, 2008 after 14 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
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.

## Indications for use
The StelKast Proven Stem Extenders are intended for use with compatible components of the Proven Knee System for the following indications: 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; and 3 Cemented use only.

Source page: https://510kreport.com/device/K081458
Methodology: https://510kreport.com/methodology