# K040538: Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Mar 17, 2004 after 15 days
- Product code: OTN (Mesh, Surgical, 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: 5 generations back to K011251 (2001). 6 ancestors in all.
39 later devices descend from it; 3 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030123: Bioarc SP Sling Kit, American Medical Systems, Inc. (2003) Summary page 1.
- K023516: Monarc Sling System, American Medical Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K041948: Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems (2004), 37 descendants of its own
- 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

## Indications for use
The BioAre SP Sling Kit is intended for the placement of a pubourethral sling for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and / or intrinsic sphincter deficiency.

Source page: https://510kreport.com/device/K040538
Methodology: https://510kreport.com/methodology