# K101297: Virtue Ventral Urethral Elevation Sling System Model 50020

- Pathway: 510(k) (Special)
- Applicant: Coloplast A/S
- Decided: Jun 3, 2010 after 24 days
- Product code: OTM (Mesh, Surgical, For Stress Urinary Incontinence, Male)
- 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: 12 generations back to K931386 (1993). 34 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082640: Virtue Ventral Urethral Elevation Sling System, Coloplast Manufacturing Us, LLC (2008) Summary page 1.
- K091152: Virtue Ventral Urethral Elevation Sling System, Model 50020, Coloplast A/S (2009) Summary page 1.

## Most influential descendants
- K113496: Virture Male Sling System with Alexis Wound Retractor Convenience Kit (2012), 1 descendant of its own
- K231891: Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (2023), 0 descendants of its own
- K111881: Virtue Male Sling System and Alexis (R) Wound Retractor Kit (2011), 0 descendants of its own

## Indications for use
The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

Source page: https://510kreport.com/device/K101297
Methodology: https://510kreport.com/methodology