510(k) · Decided
DecidedVirtue Male Sling System with Alexis Wound Retractor Convenience Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast · OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
Cleared on Sep 25, 2023 as substantially equivalent to K113496 (Coloplast A/S, 2012) after a 90-day review. Its family tree reaches back 14 generations to 1993.
- Decided
- Sep 25, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- OTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K931386 (1993). 37 ancestors in all, the oldest K920213 (1992). No later device cites it as a predicate yet.
- Root · 14 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations between
- 3 generations backK091152 Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S · 2009
- 2 generations backK101297 Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S · 2010
- 1 generation backK113496 Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S · 2012
- This deviceK231891 Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast · 2023
Show all 14 generations
- Root · 14 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 13 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 12 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 11 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 10 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 9 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 8 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 7 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 6 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 5 generations backK053371 Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 2006 · Recalled
- 4 generations backK082640 Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC · 2008
- 3 generations backK091152 Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S · 2009
- 2 generations backK101297 Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S · 2010
- 1 generation backK113496 Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S · 2012
- This deviceK231891 Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −13 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −12 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −11 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −10 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −9 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −8 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −7 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −6 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −5 | K053371 | Ams Male Transobturator Sling System | American Medical Systems, Inc. | 2006 | 3 |
| −4 | K082640 | Virtue Ventral Urethral Elevation Sling System | Coloplast Manufacturing Us, LLC | 2008 | — |
| −3 | K091152 | Virtue Ventral Urethral Elevation Sling System, Model 50020 | Coloplast A/S | 2009 | — |
| −2 | K101297 | Virtue Ventral Urethral Elevation Sling System Model 50020 | Coloplast A/S | 2010 | — |
| −1 | K113496 | Virture Male Sling System with Alexis Wound Retractor Convenience Kit | Coloplast A/S | 2012 | — |
| 0 (this device) | K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | Coloplast | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 4 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OTM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OTM device
- #1 K242960 AdVance™ XP Male Sling System (720163-03)score 11.7 · 12 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113496 | Virture Male Sling System with Alexis Wound Retractor Convenience KitSummary page 4…uct Classification: Class II (Virtue) Class I (Alexis) III. PREDICATE DEVICE 510(k) Number: K113496 Trade Name: Virtue Male Sling System with Alexis Wound Retractor The predicate has not been subject to… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 37 ancestors have a recall of any class.
How does its category compare?
All OTM devicesOTM Mesh, Surgical, For Stress Urinary Incontinence, Male: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OTM
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OTM
Too few OTM 510(k)s in any year since 2007 to give a median.
Recalls per year · OTM
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OTM
47in 2025
MAUDE reports naming product code OTM, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 33 |
| 2014 | 0 | — | 1 | 72 |
| 2015 | 0 | — | 0 | 42 |
| 2016 | 0 | — | 0 | 26 |
| 2017 | 0 | — | 0 | 16 |
| 2018 | 1 | — | 0 | 111 |
| 2019 | 0 | — | 0 | 406 |
| 2020 | 0 | — | 0 | 261 |
| 2021 | 1 | — | 0 | 213 |
| 2022 | 0 | — | 0 | 199 |
| 2023 | 1 | — | 0 | 28 |
| 2024 | 1 | — | 0 | 43 |
| 2025 | 0 | — | 0 | 47 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (113 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231891 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231891: Virtue Male Sling System with Alexis Wound Retractor Convenience Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231891
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026