# K021160: Dermmatrix Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Carbon Medical Technologies, Inc.
- Decided: Jun 12, 2002 after 62 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: 4 generations back to K921895 (1992). 13 ancestors in all.
38 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993459: Modification to Brennen Biosynthetic Surgical Mesh Matrix, Advanced Uroscience, Inc. (1999) Summary page 1.
- K992556: Permacol, Tissue Science Laboratories, Plc (2000) Summary page 1.
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 1.

## Most influential descendants
- K050445: Ams Collagen Dermal Matrix (2005), 30 descendants of its own
- K051485: Ams Pelvic Floor Repair System (2005), 17 descendants of its own
- K073219: WMT Collagen Dermal Matrix, 4 CM X 7 CM, Model 89XM-4X07, VMT Collagen Dermal Matrix, 6 CM X 8 CM, Model 89XM-6X08 (2008), 12 descendants of its own
- K120019: Collagen Ribbon (2012), 11 descendants of its own
- K080185: Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP Prolapse Repair System (2008), 11 descendants of its own

## Indications for use
Intended for use in the treatment of hernias where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support including urethral slings, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor, bladder support, tissue repair, and sacrocolposuspension.

Source page: https://510kreport.com/device/K021160
Methodology: https://510kreport.com/methodology