# K153633: Endoform Reconstructive Template

- Pathway: 510(k) (Special)
- Applicant: Aroa Biosurgery Limited (Formerly Mesynthes Limited)
- Decided: Mar 15, 2016 after 88 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 21 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 27 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
- K250598: Endoform Reconstructive Template - PLGA (2025), 0 descendants of its own

## Recalls of this device
- Apr 6, 2018 · Class II · Z-0420-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0429-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0434-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0435-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0415-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0417-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0418-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0421-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0428-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0430-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0431-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0432-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0433-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0416-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0419-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0422-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0423-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0424-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0425-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0426-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over
- Apr 6, 2018 · Class II · Z-0427-2019: Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over

## 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 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/K153633
Methodology: https://510kreport.com/methodology