# K111881: Virtue Male Sling System and Alexis (R) Wound Retractor Kit

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: Aug 17, 2011 after 47 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: 13 generations back to K931386 (1993). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101297: Virtue Ventral Urethral Elevation Sling System Model 50020, Coloplast A/S (2010) Summary page 1.
- K041711: Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304, Applied Medical Resources Corp. (2004) Summary page 1.

## Indications for use
The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI). The Applied Alexis Wound Retractor is indicated for usc to: ¢ Access the abdominal cavity during surgery through an atraumatically retracted incision. ¢ Deliver maximum exposure of the abdominal cavity with minimum inctsion. » Protect against wound contamination during laparoscopic and open surgery. The smaller two sizes of Alexis are also intended to be used to: o Scal off the incision opening to permit insufflating the peritoneum. ¢ Convert the incision wound to"an additional trocar port site. » Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

Source page: https://510kreport.com/device/K111881
Methodology: https://510kreport.com/methodology