# K141053: Ovine Tissue Matrix (Otm)

- Pathway: 510(k) (Traditional)
- Applicant: TELA Bio, Inc.
- Decided: Dec 11, 2014 after 231 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: 7 generations back to K921895 (1992). 25 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130547: Endoform Reconstructive Template, Mesynthe, Ltd. (2013) Summary page 5.

## Most influential descendants
- K153632: Endoform Reconstructive Template (2016), 1 descendant of its own
- K181935: Endoform Reconstructive Template - Non Absorbable (2018), 0 descendants of its own

## Indications for use
Ovine Tissue Matrix is intended for use as a surgical mesh to reinforce and/or repair soft tissuec where weakness exists. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

Source page: https://510kreport.com/device/K141053
Methodology: https://510kreport.com/methodology