# K980276: Stelkast Proven Cemented, Semi-Constrained Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Apr 24, 1998 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 5 cite it directly.
0 of 7 devices 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.

## Most influential descendants
- K122883: Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System (2013), 4 descendants of its own
- K162222: GENflex2 Total Knee System (2016), 3 descendants of its own
- K173875: GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert (2018), 2 descendants of its own
- K240669: ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System (2024), 1 descendant of its own
- K262251: ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert) (2026), 0 descendants of its own

## Recalls of this device
- Sep 3, 2008 · Not classified · Z-0308-2009: Five (5) Three Peg Patella SC1591-29 were packaged in containers labeled for SC1591-38 sharing the same lot number.

## 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/K980276
Methodology: https://510kreport.com/methodology