# K013906: HLS Noetos System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Jul 17, 2002 after 233 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: 2 generations back to K884796 (1989). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000232: Rotaglide + Modular Knee System with Fixed Meniscus, Corin USA (2000) Summary page 1.
- K872379: Insall/Burstein* II Modular Total Knee, Zimmer, Inc. (1987) Summary page 1.
- K984158: P.F.C. Modular Plus Offset Tibial Tray, Depuy, Inc. (1999) Summary page 1.
- K991581: Nexgen Complete Knee Solution Legacy Posterior Stabilized (LPS); LPS-Flex Fixed Bearing Femoral and Articular Surface CO, Zimmer, Inc. (1999) Summary page 1.

## Most influential descendants
- K094013: HLS Kneetec System (2011), 1 descendant of its own
- K111970: Kneetec PFJ&HLS Kneetec Patellar Component (2012), 0 descendants of its own
- K032079: HLS Noetos System (2003), 0 descendants of its own

## 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 cemented system with fixed tibial bearing is intended for cemented use only.

Source page: https://510kreport.com/device/K013906
Methodology: https://510kreport.com/methodology