# K171817: Biodesign Diaphragmatic Hernia Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorporated
- Decided: Mar 13, 2018 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: 9 generations back to K881854 (1988). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133011: Diaphragmatic Hernia Graft, Cook Biotech, Inc. (2014) Summary page 4.

## Indications for use
The Biodesign® Diaphragmatic Hernia Graft is intended for implantation to reinforce soft tissues where weakness exists including the repair of diaphragmatic/hiatal hernias. The graft is supplied sterile and is intended for one time use only.

Source page: https://510kreport.com/device/K171817
Methodology: https://510kreport.com/methodology