# K160181: Colorado Therapeutics Xenograft Implant

- Pathway: 510(k) (Traditional)
- Applicant: Colorado Therapeutics, LLC
- Decided: Oct 20, 2016 after 267 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: 8 generations back to K881854 (1988). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120605: Permacol Surgical Implant, Covidien, LLC (2012) Summary page 4.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 4.

## Most influential descendants
- K172937: Colorado Therapeutics Xenograft Implant (2017), 0 descendants of its own

## 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/K160181
Methodology: https://510kreport.com/methodology