# K050445: Ams Collagen Dermal Matrix

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Jun 17, 2005 after 115 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931386 (1993). 37 ancestors in all.
30 later devices descend from it; 3 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021160: Dermmatrix Surgical Mesh, Carbon Medical Technologies, Inc. (2002) Summary page 1.
- K992159: Surgisis Sling, Cook Biotech, Inc. (1999) Summary page 1.
- K040538: Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996, American Medical Systems, Inc. (2004) Summary page 1.
- K041948: Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems, American Medical Systems, Inc. (2004) Summary page 1.
- K040623: Ams Perigee System, American Medical Systems, Inc. (2004) Summary page 1.
- K040537: Ams Apogee Vault Suspension System, American Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- 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
- K131143: Trellis Collagen Ribbon (2013), 10 descendants of its own

## Recalls of this device
- Dec 5, 2008 · Not classified · Z-0932-2009: The product size shown on the carton labeling does not match the size on the product inside.

## Indications for use
The AMS collagen dermal matrix is intended for use in the treatment of hemias 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 fimited 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, sacral colposuspension and reinforcement in the repair of Peyronie's disease. By providing pubourethral support, the AMS collagen dermal matrix may be used for the treatment of urinary incontinence resulting from urethral hypemmobility or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K050445
Methodology: https://510kreport.com/methodology