# K141084: Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Acell, Inc.
- Decided: Jun 17, 2015 after 415 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: 8 generations back to K921895 (1992). 35 ancestors in all.
3 later devices descend from it; 1 cites 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)
- K040621: Acell Ubm Surgical Mesh, Acell, Inc. (2004) Summary page 4.
- K041140: Acell Ubm Surgical Mesh ML and Mlplus, Acell, Inc. (2004) Summary page 4.
- K034039: Sis Plastic Surgery Matrix, Cook Biotech, Inc. (2004) Summary page 4.

## Most influential descendants
- K162554: Gentrix Surgical Matrix (2016), 2 descendants of its own
- 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
MatriStem Surgical Matrix RS (2-layer) and PSM (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. MatriStem Surgical Matrix PSMX (6-layer) is 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. MatriStem Pelvic Floor Matrix (6-layer) is intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological or gynecological surgery. Reinforcement of soft tissue within urological and gynecological surgery includes, but is not limited to, the following procedures: pubourethral support, urethral repair, transabdominal reconstruction of pelvic floor and vaginal prolapse repair, bladder support, and sacrocolposuspension. By providing pubourethral support, MatriStem Pelvic Floor Matrix may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K141084
Methodology: https://510kreport.com/methodology