# K111695: Hybrid Graft

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Apr 2, 2012 after 291 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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: 3 generations back to K921895 (1992). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974540: Sis Hernia Repair Device, Sentron Medical, Inc. (1998) Summary page 1.
- K062697: Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft, Cook Biotech, Inc. (2006) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 3.
- K061533: Proceed Ventral Patch, ETHICON, Inc. (2006) Summary page 1.
- K033337: Ultrapro Mesh, ETHICON, Inc. (2004) Summary page 1.

## Indications for use
The Hybrid Graft is intended to be implanted to reinforce soft tissues where weakness exists. Indications for use include the repair of a hernia or body wall defect requiring the addition of a reinforcing or bridging material to obtain the desired surgical result, This graft is supplied sterile and is intended for one-time use,

Source page: https://510kreport.com/device/K111695
Methodology: https://510kreport.com/methodology