# K250598: Endoform Reconstructive Template - PLGA

- Pathway: 510(k) (Traditional)
- Applicant: Aroa Biosurgery, Ltd.
- Decided: Jun 3, 2025 after 95 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: 8 generations back to K921895 (1992). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153633: Endoform Reconstructive Template, Aroa Biosurgery Limited (Formerly Mesynthes Limited) (2016) Summary page 5.

## Indications for use
Endoform™ Reconstructive Template – PLGA 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 material to obtain the desired surgical outcome.

Source page: https://510kreport.com/device/K250598
Methodology: https://510kreport.com/methodology