# K162222: GENflex2 Total Knee System

- Pathway: 510(k) (Special)
- Applicant: Stelkast, Inc.
- Decided: Sep 7, 2016 after 30 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: 8 generations back to K810258 (1981). 47 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 51 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 5.
- K063211: Proven Knee System High Flexion Tibial Insert, Stelkast Company (2007) Summary page 5.
- K122883: Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System, Stelkast Company (2013) Summary page 5.

## Most influential descendants
- 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

## Indications for use
The GENFlex2 Total Knee System is intended for: Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. The device is intended for cemented use only.

Source page: https://510kreport.com/device/K162222
Methodology: https://510kreport.com/methodology