# K120262: HLS Uni Evolution & U-Kneetec

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Jul 25, 2012 after 180 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: 3 generations back to K881779 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022211: HLS Uni Evolution Prosthesis, Tornier (2003) Summary page 3.
- K880155: Miller/Galante Precoat Unicompartmental Knee, Zimmer, Inc. (1988) Summary page 2.
- K942263: Miller/Galante Precoat Unicompartmental Knee System, Zimmer, Inc. (1995) Summary page 2.

## Indications for use
The HLS Uni Evolution and U-KneeTec unicompartmental knee prostheses are indicated for the replacement of the medial or lateral compartment of the femorotibial knee joint when only one compartment is affected, in order to reduce pain and restore knee function in comparison with preoperative status. These devices are indicated in the treatment of primary or secondary femorotibial osteoarthritis. The HLS Uni Evolution and U-KneeTec knee prostheses are intended for cemented use only.

Source page: https://510kreport.com/device/K120262
Methodology: https://510kreport.com/methodology