# K172937: Colorado Therapeutics Xenograft Implant

- Pathway: 510(k) (Special)
- Applicant: Colorado Therapeutics, LLC
- Decided: Oct 25, 2017 after 29 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K881854 (1988). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160181: Colorado Therapeutics Xenograft Implant, Colorado Therapeutics, LLC (2016) Summary page 4.

## Indications for use
Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is supplied sterile. It is intended for one-time use.

Source page: https://510kreport.com/device/K172937
Methodology: https://510kreport.com/methodology