# K231891: Virtue Male Sling System with Alexis Wound Retractor Convenience Kit

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast
- Decided: Sep 25, 2023 after 90 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: 14 generations back to K931386 (1993). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113496: Virture Male Sling System with Alexis Wound Retractor Convenience Kit, Coloplast A/S (2012) Summary page 4.

## 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 use to: Access the abdominal cavity during surgery through an atraumatically retracted incision. Deliver maximum exposure of the abdominal cavity with minimum incision. Protect against wound contamination during laparoscopic and open surgery. The smaller two sizes of Alexis are also intended to be used to: Seal 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/K231891
Methodology: https://510kreport.com/methodology