# K162554: Gentrix Surgical Matrix

- Pathway: 510(k) (Special)
- Applicant: Acell, Inc.
- Decided: Oct 21, 2016 after 38 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: 9 generations back to K921895 (1992). 36 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 39 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141084: Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix, Acell, Inc. (2015) Summary page 4.

## Most influential descendants
- K182259: Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal (2019), 0 descendants of its own
- K170763: Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend (2017), 0 descendants of its own

## Indications for use
Gentrix™ Surgical Matrix 2-layer and 3-layer are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, 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. Gentrix™ Surgical Matrix 6-layer and 8-Layer 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/K162554
Methodology: https://510kreport.com/methodology