# K022211: HLS Uni Evolution Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: May 22, 2003 after 318 days
- Product code: HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K881779 (1988). 5 ancestors in all.
1 later device descends from it; 1 cites 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)
- K010685: Modification to Miller/Galante Precoat Unicompartmental Knee System (8 MM Articular Surface), Zimmer, Inc. (2001)
- K014171: Advance Unicondylar Knee System, Wrightmedicaltechnologyinc (2002)
- K954186: Sled Unicompartment Knee System, Link America, Inc. (1996) Summary page 1.

## Most influential descendants
- K120262: HLS Uni Evolution & U-Kneetec (2012), 0 descendants of its own

## Indications for use
The HLS Uni Evolution prosthesis is intended for the replacement of the medial or lateral compartment of the femoro-tibial knee joint, when only one side of the knee is affected. This device is indicated in case of primary or secondary femoro-tibial arthritis. The HLS Uni Evolution prosthesis is intended for cemented use only.

Source page: https://510kreport.com/device/K022211
Methodology: https://510kreport.com/methodology