# K162461: Endoform Plastics and Reconstructive Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Aroa Biosurgery (Formerly Mesynthes Limited)
- Decided: Dec 20, 2016 after 109 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). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 4.
- K161221: Biodesign Sling, Biodesign Plastic Surgery Matrix, Biodesign Anal Fistula Plug, Cook Biotech Incorporated (2016) Summary page 4.

## Indications for use
Endoform® Plastics and Reconstructive Matrix is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

Source page: https://510kreport.com/device/K162461
Methodology: https://510kreport.com/methodology