# K040621: Acell Ubm Surgical Mesh

- Pathway: 510(k) (Abbreviated)
- Applicant: Acell, Inc.
- Decided: Apr 14, 2004 after 36 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). 24 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K021637: Acell Ubm Lyophilized Wound Dressing, Acell, Inc. (2002) Summary page 1.
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.

## Most influential descendants
- K041140: Acell Ubm Surgical Mesh ML and Mlplus (2004), 4 descendants of its own
- 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 is intended for implantation to reinforce soft tissues. The device is intended for one-time use.

Source page: https://510kreport.com/device/K040621
Methodology: https://510kreport.com/methodology