# K132655: Retroarc Retropubic Sling System

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Nov 20, 2013 after 86 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: 8 generations back to K011251 (2001). 10 ancestors in all.
3 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)
- K081613: Sparc System / Monarc, Monarc C, Monarc + Systems, American Medical Systems, Inc. (2008) Summary page 1.

## Most influential descendants
- 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

## Indications for use
The RetroArcTM Retropubic Sling System is 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 (ISD).

Source page: https://510kreport.com/device/K132655
Methodology: https://510kreport.com/methodology