# K160869: Biodesign Tissue Graft, Biodesign Dural Graft,  Biodesign Peyronie's Repair Graft

- Pathway: 510(k) (Special)
- Applicant: Cook Biotech Incorporated
- Decided: Apr 29, 2016 after 30 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931386 (1993). 48 ancestors in all.
No later device cites it as a predicate yet.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 6.
- K031850: Durasis Dural Substitute, Cook Biotech, Inc. (2003) Summary page 6.
- K062320: Surgisis Peyronie's Repair Graft, Model SPR-100, Cook Biotech, Inc. (2006) Summary page 6.

## Recalls of this device
- Nov 22, 2024 · Class II · Z-0834-2025: Incorrect version of IFU was used rather than updated version; and incorrect expiration date was used on two of the products.

## Indications for use
Biodesign Tissue Graft is intended to be used for implantation to reinforce soft tissue Biodesign Dural Graft is intended for use as a dura substitute for the repair of dura mater. Biodesign Peyronie's Repair Graft is intended for implantation to reinforce soft tissue where weakness exists in the urological anatomy, including but not limited to the repair of tunica albuginea defects, and reinforcement in the repair of Peyronie’s disease.

Source page: https://510kreport.com/device/K160869
Methodology: https://510kreport.com/methodology