# K120740: Cols® Fixation System

- Pathway: 510(k) (Special)
- Applicant: Fournitures Hospitalieres Industrie
- Decided: Mar 5, 2013 after 358 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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: 4 generations back to K915424 (1993). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080974: TLS Fixation System, Fournitures Hospitalieres Industrie (2008) Summary page 1.

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

Source page: https://510kreport.com/device/K120740
Methodology: https://510kreport.com/methodology