# K122883: Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee System

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Aug 5, 2013 after 319 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
Longest line of descent: 7 generations back to K810258 (1981). 46 ancestors in all.
4 later devices descend from it; 4 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 2.
- K063211: Proven Knee System High Flexion Tibial Insert, Stelkast Company (2007) Summary page 2.
- K094035: Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM, Stelkast Company (2011) Summary page 2.
- K113550: Vanguard Complete Knee System, Biomet Manufacturing Corp (2012)

## Most influential descendants
- 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
- Dec 1, 2014 · Class II · Z-0970-2015: Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition where a lead in radius on the anterior locking tab is not present on certain insert lots. The absence of th

## Indications for use
The Proven Gen-FlexTM Total Knee System is intended for: 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 tissue integrity are present. The device is intended for cemented use only.

Source page: https://510kreport.com/device/K122883
Methodology: https://510kreport.com/methodology