# K063211: Proven Knee System High Flexion Tibial Insert

- Pathway: 510(k) (Traditional)
- Applicant: Stelkast Company
- Decided: Jan 18, 2007 after 87 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.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## 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

## 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 tissue integrity are present. 3. For cemented use only.

Source page: https://510kreport.com/device/K063211
Methodology: https://510kreport.com/methodology