# K081613: Sparc System / Monarc, Monarc C, Monarc + Systems

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Sep 17, 2008 after 100 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: 7 generations back to K011251 (2001). 9 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041948: Sparc, Monarc, Bioarc SP and Bioarc to Sling Systems, American Medical Systems, Inc. (2004) Summary page 1.
- K051530: Monarc + Subfascial Hammock, Model 72404193; Monarc C Subfascial Hammock, Model 72404195., American Medical Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K132655: Retroarc Retropubic Sling System (2013), 3 descendants of its own
- K183134: ArcTV Transvaginal Sling System (2019), 2 descendants of its own
- K222293: ArcSP Suprapubic Sling System (2022), 0 descendants of its own
- K222468: ArcTO Transobturator Sling System (2022), 0 descendants of its own
- K131229: Sparc System and Monarc, Monarc, and Monarc C Systems (2013), 0 descendants of its own

## Indications for use
Intended for the placement of suburethral mesh for the treatment of female stress urinary incontinence (SUI) resulting from urethral hypermobility and /or intrinsic sphincter deficiency. Intended for the placement of 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/K081613
Methodology: https://510kreport.com/methodology