# K170016: Biodesign Fistula Plug

- Pathway: 510(k) (Traditional)
- Applicant: Cook Biotech Incorporated
- Decided: Jun 21, 2017 after 169 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: 5 generations back to K921895 (1992). 11 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050337: Sis Fistula Plug, Cook Biotech, Inc. (2005) Summary page 4.

## Most influential descendants
- K191696: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft (2019), 4 descendants of its own
- K202430: Kerecis Reconstruct (2021), 3 descendants of its own
- K251844: Kerecis SurgiBind (50241) (2025), 0 descendants of its own
- K251224: Restrata Soft Tissue Reinforcement (STR) (2025), 0 descendants of its own
- K243843: Tendon Protect (50242) (2025), 0 descendants of its own

## Indications for use
The Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas.

Source page: https://510kreport.com/device/K170016
Methodology: https://510kreport.com/methodology