# K170763: Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend

- Pathway: 510(k) (Traditional)
- Applicant: Acell, Inc.
- Decided: Jun 8, 2017 after 87 days
- Product code: FTM (Mesh, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K921895 (1992). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162554: Gentrix Surgical Matrix, Acell, Inc. (2016) Summary page 4.

## Recalls of this device
- Feb 14, 2019 · Class II · Z-1033-2019: The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.
- Feb 14, 2019 · Class II · Z-1032-2019: The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.

## Indications for use
Gentrix Surgical Matrix Thick and Gentrix Surgical Matrix Extend are intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

Source page: https://510kreport.com/device/K170763
Methodology: https://510kreport.com/methodology