# K251224: Restrata Soft Tissue Reinforcement (STR)

- Pathway: 510(k) (Traditional)
- Applicant: Acera Surgical, Inc.
- Decided: Jun 20, 2025 after 60 days
- Product code: OXF (Mesh, Surgical, Absorbable, 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: 8 generations back to K921895 (1992). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202430: Kerecis Reconstruct, Kerecis Limited (2021) Summary page 5.

## Indications for use
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/K251224
Methodology: https://510kreport.com/methodology