# K131229: Sparc System and Monarc, Monarc, and Monarc C Systems

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems
- Decided: Dec 5, 2013 after 219 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K011251 (2001). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081613: Sparc System / Monarc, Monarc C, Monarc + Systems, American Medical Systems, Inc. (2008) Summary page 2.

## Recalls of this device
- Oct 15, 2014 · Class II · Z-0805-2015: During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdV

## Indications for use
Sparc System: 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. Monarc, Monarc + and Monarc C Systems: 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.

Source page: https://510kreport.com/device/K131229
Methodology: https://510kreport.com/methodology