# K153632: Endoform Reconstructive Template

- Pathway: 510(k) (Traditional)
- Applicant: Aroa Biosurgery Limited (Formerly Mesynthes Limited)
- Decided: Jun 16, 2016 after 181 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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). 26 ancestors in all.
1 later device descends 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)
- K141053: Ovine Tissue Matrix (Otm), TELA Bio, Inc. (2014) Summary page 4.

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

## Indications for use
Endoform® Reconstructive Template -Non Absorbable is intended for use as a surgical mesh to reinforce and/ or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing or bridging material to obtain the desired surgical outcome.

Source page: https://510kreport.com/device/K153632
Methodology: https://510kreport.com/methodology