# K051530: Monarc + Subfascial Hammock, Model 72404193; Monarc C Subfascial Hammock, Model 72404195.

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Jul 8, 2005 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: 6 generations back to K011251 (2001). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023516: Monarc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K040538: Bioarc SP Sling Kit and Bioarc to Sling Kit, Models 72403851, 72403996, American Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K081613: Sparc System / Monarc, Monarc C, Monarc + Systems (2008), 5 descendants of its own
- 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

## 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
The Monarc and BioArc TO Subfascial Hammocks are intended for the placement of a suburethral 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/K051530
Methodology: https://510kreport.com/methodology