# K030460: Modification to Brennen Biosynthetic Surgical Mesh Matrix

- Pathway: 510(k) (Special)
- Applicant: Brennen Medical, Inc.
- Decided: Mar 7, 2003 after 23 days
- Product code: PAG (Mesh, Surgical, Non-Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator)
- 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: 2 generations back to K982403 (1998). 2 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982403: Brennen Biosynthetic Surgical Mesh Matrix, Brennen Medical, Inc. (1998) Summary page 1.
- K993459: Modification to Brennen Biosynthetic Surgical Mesh Matrix, Advanced Uroscience, Inc. (1999) Summary page 1.

## Most influential descendants
- K081272: Porcine Surgical Mesh; Dermal Matrix (2008), 6 descendants of its own
- K133223: Xenmatrix AB Surgical Graft (2014), 2 descendants of its own
- K151177: XenMatrix AB Surgical Graft (2015), 1 descendant of its own
- K111436: Porcine Surgical Mesh, Porcine Dermal Matrix (2011), 1 descendant of its own
- K162193: XenMatrix AB Surgical Graft (2016), 0 descendants of its own

## Indications for use
For use in the treatment of hernias where the connective tissue has ruptured or as a sling material to support the repositioning and support of the bladder neck for female urinary incontinence resulting from urethral hypermobility or sphincter deficiency.

Source page: https://510kreport.com/device/K030460
Methodology: https://510kreport.com/methodology