# K032079: HLS Noetos System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Oct 2, 2003 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
Longest line of descent: 3 generations back to K884796 (1989). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984158: P.F.C. Modular Plus Offset Tibial Tray, Depuy, Inc. (1999) Summary page 2.
- K963148: Nexgen Complete Knee Solution, Zimmer, Inc. (1997) Summary page 2.
- K013906: HLS Noetos System, Tornier (2002)

## Indications for use
This device is indicated for use as a total knee replacement for the relief of pain and significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis. This device is also indicated for the revision of knee prosthesis. The HLS NOETOS Revision prosthesis is intended for cemented use only.

Source page: https://510kreport.com/device/K032079
Methodology: https://510kreport.com/methodology