# K094013: HLS Kneetec System

- Pathway: 510(k) (Special)
- Applicant: Tornier
- Decided: May 5, 2011 after 492 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). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013906: HLS Noetos System, Tornier (2002) 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.
- K833921: Agc Total Knee Prosthesis, Biomet, Inc. (1984). Our reading of the summary gave K833021, FDA’s number for Peri-Guard Pericardial Patch-Hernia (Genetic). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “AGC Total Knee System”.
- K912245: Agc Revision Knee Prothesis, Biomet, Inc. (1991) Summary page 1.
- K984054: Agc V2 Revision Knee System, Biomet, Inc. (1999) Summary page 1.

## Most influential descendants
- K111970: Kneetec PFJ&HLS Kneetec Patellar Component (2012), 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 intended for the revision of knee prostheses. The HLS Kneetec is intended for cemented use only.

Source page: https://510kreport.com/device/K094013
Methodology: https://510kreport.com/methodology