# K080974: TLS Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Jul 1, 2008 after 88 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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 K915424 (1993). 10 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980155: Endobutton Continuous Loop, Smith & Nephew, Inc. (1998) Summary page 1.
- K060367: Tenolig, Fournitures Hospitalieres Industrie (2006) Summary page 1.
- K992945: Rci Fixation Screws (with Assorted Sizes), Smith & Nephew, Inc. (1999) Summary page 2.

## Most influential descendants
- K120740: Cols® Fixation System (2013), 0 descendants of its own
- K113591: Cols Peek (2011), 0 descendants of its own

## Indications for use
The TLS® Fixation System is designed for the fixation of tendons graft to the femur and tibia during orthopaedic procedures for Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) reconstructions.

Source page: https://510kreport.com/device/K080974
Methodology: https://510kreport.com/methodology