# K051976: Proven Revision Modular Tibial Tray

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Oct 17, 2005 after 88 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: 5 (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
- Oct 5, 2007 · Not classified · Z-0479-2008: The screws may fracture
- Oct 5, 2007 · Not classified · Z-0481-2008: The screws may fracture
- Oct 5, 2007 · Not classified · Z-0482-2008: The screws may fracture
- Oct 5, 2007 · Not classified · Z-0483-2008: The screws may fracture
- Oct 5, 2007 · Not classified · Z-0480-2008: The screws may fracture

## Indications for use
The StelKast Proven Revision Modular Tibial Tray is intended for cemented use only in total knee replacement with the following indications: 1. osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems; and 2. revision of failed previous reconstructions where sufficient bone stock soft integrity are present.

Source page: https://510kreport.com/device/K051976
Methodology: https://510kreport.com/methodology