# K062320: Surgisis Peyronie's Repair Graft, Model SPR-100

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech, Inc.
- Decided: Oct 2, 2006 after 54 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: 10 generations back to K931386 (1993). 38 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K050445: Ams Collagen Dermal Matrix, American Medical Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K160869: Biodesign Tissue Graft, Biodesign Dural Graft,  Biodesign Peyronie's Repair Graft (2016), 0 descendants of its own

## Indications for use
The SURGISIS® 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. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K062320
Methodology: https://510kreport.com/methodology