# K130547: Endoform Reconstructive Template

- Pathway: 510(k) (Traditional)
- Applicant: Mesynthe, Ltd.
- Decided: May 31, 2013 after 88 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: 6 generations back to K921895 (1992). 24 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.
- K062697: Sis Hernia Repair Device, Surgisis Gold Hernia Repair Graft, Cook Biotech, Inc. (2006) Summary page 1.
- K070560: LRTM Surgical Mesh, Lifecell Corp. (2007) Summary page 1.

## Most influential descendants
- K141053: Ovine Tissue Matrix (Otm) (2014), 2 descendants of its own
- K153632: Endoform Reconstructive Template (2016), 1 descendant of its own
- K153633: Endoform Reconstructive Template (2016), 1 descendant of its own
- K250598: Endoform Reconstructive Template - PLGA (2025), 0 descendants of its own
- K181935: Endoform Reconstructive Template - Non Absorbable (2018), 0 descendants of its own

## Indications for use
Endoform Reconstructive Template is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include, but are not limited to the following procedures; hernioplasty and repair of body wall defects. The device allows reinforcement or bridging of a deficit to obtain the desired surgical outcome. Endoform Reconstructive Template is intended for single use only.

Source page: https://510kreport.com/device/K130547
Methodology: https://510kreport.com/methodology