# K053371: Ams Male Transobturator Sling System

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Feb 3, 2006 after 60 days
- Product code: OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931386 (1993). 31 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982155: Short Straight-in Bone Screw Fixation System, Influence, Inc. (1998) Summary page 1.
- K023516: Monarc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K011251: Sparc Sling System, American Medical Systems, Inc. (2001)
- K040537: Ams Apogee Vault Suspension System, American Medical Systems, Inc. (2004) Summary page 1.
- K040623: Ams Perigee System, American Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K082640: Virtue Ventral Urethral Elevation Sling System (2008), 5 descendants of its own
- K091152: Virtue Ventral Urethral Elevation Sling System, Model 50020 (2009), 4 descendants of its own
- K101297: Virtue Ventral Urethral Elevation Sling System Model 50020 (2010), 3 descendants of its own
- K182169: AdVance XP Male Sling (2018), 2 descendants of its own
- K211847: AdVance XP Male Sling System (2021), 1 descendant of its own

## Recalls of this device
- Oct 15, 2014 · Class II · Z-0806-2015: 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
- Oct 19, 2012 · Class II · Z-0259-2013: American Medical Systems (AMS) is issuing a voluntary recall on a number of lots of the AdVance Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorb
- Sep 7, 2010 · Not classified · Z-0808-2011: American Medical Systems (AMS) is recalling all lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013. Internal testing has indicated the potential for degrad

## Indications for use
The AMS Male Transobturator Sling System is indicated for a sub-urethral sling implant to treat male stress urinary incontinence.

Source page: https://510kreport.com/device/K053371
Methodology: https://510kreport.com/methodology