# K161221: Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug

- Pathway: 510(k) (Special)
- Applicant: Cook Biotech Incorporated
- Decided: May 26, 2016 after 27 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). 20 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 27 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 6.
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 6.
- K050337: Sis Fistula Plug, Cook Biotech, Inc. (2005) Summary page 6.

## 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
For implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gasteroenterological anatomy including but not limited to the following procedures: transvaginal repair of stress urinary incontinence, such as pubourethral support and bladder support, and transabdominal repair of apical vaginal prolapse, colon and rectal prolapse, and sacrocolposuspension. By providing pubourethral support, the sling may be used for the treatment of urinary incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency. For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic or reconstructive surgery. For implantation to reinforce soft tissue where a rolled configuration is required, for repair of anal, rectal and enterocutaneous fistulas.

Source page: https://510kreport.com/device/K161221
Methodology: https://510kreport.com/methodology