# K241126: OviTex PRS

- Pathway: 510(k) (Special)
- Applicant: TELA Bio, Inc.
- Decided: May 22, 2024 after 29 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: 1 generation back to K183398 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183398: Endoform Restella, Aroa Biosurgery, Ltd. (2019) Summary page 4.

## Indications for use
OviTex PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K241126
Methodology: https://510kreport.com/methodology