# K202430: Kerecis Reconstruct

- Pathway: 510(k) (Traditional)
- Applicant: Kerecis Limited
- Decided: May 2, 2021 after 250 days
- Product code: OXH (Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery)
- 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: 7 generations back to K921895 (1992). 29 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191696: Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft, Cook Biotech Incorporated (2019) Summary page 4.

## Most influential descendants
- 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 subject device is indicated for: For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

Source page: https://510kreport.com/device/K202430
Methodology: https://510kreport.com/methodology