# K214070: OviTex PRS (Long Term Resorbable)

- Pathway: 510(k) (Traditional)
- Applicant: Tela Bio
- Decided: Mar 21, 2023 after 449 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.
1 later device descends from it; 1 cites it directly.
0 of 3 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.

## Most influential descendants
- K243595: OviTex PRS (Long-Term Resorbable) (2024), 0 descendants of its own

## Indications for use
OviTex PRS (Long-Term Resorbable) 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/K214070
Methodology: https://510kreport.com/methodology