# K041140: Acell Ubm Surgical Mesh ML and Mlplus

- Pathway: 510(k) (Abbreviated)
- Applicant: Acell, Inc.
- Decided: Jul 7, 2004 after 68 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: 7 generations back to K921895 (1992). 25 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 30 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 1.
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 1.

## Most influential descendants
- K141084: Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix (2015), 3 descendants of its own
- 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
The ACell UBM Surgical Mesh ML and MLPIus are intended for implantation to reinforce soft tissue where weakness exists in urological, gynecological, and gastroenterological anatomy including, but not limited to the following procedures: pubourethral support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, sacrocolposuspension, hernia and body wall repair, and esophageal repair. By providing pubourethral support, the ACell surgical mesh may be used for the treatment of urinary incontinence resulting from urethral hypermobility and intrinsic sphincter deficiency. The device is intended for one-time use.

Source page: https://510kreport.com/device/K041140
Methodology: https://510kreport.com/methodology