# K023516: Monarc Sling System

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Nov 19, 2002 after 29 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: 4 generations back to K011251 (2001). 4 ancestors in all.
102 later devices descend from it; 10 cite it directly.
0 of 107 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011251: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K013355: Sparc Sling System, American Medical Systems, Inc. (2001) Summary page 1.
- K020663: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K021263: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K040623: Ams Perigee System (2004), 70 descendants of its own
- K040537: Ams Apogee Vault Suspension System (2004), 70 descendants of its own
- K040538: Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996 (2004), 39 descendants of its own
- 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

## Recalls of this device
- Jul 28, 2003 · Not classified · Z-1019-04: Insertion needles from the former version of the product were packaged with the new sling with dilator that is different than the old version and not compatible with the old needles.

## Indications for use
The MONARC™ Sling System 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/K023516
Methodology: https://510kreport.com/methodology