510(k) · Cleared
ClearedVirtue Ventral Urethral Elevation Sling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast Manufacturing Us, LLC · OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
Cleared on Oct 17, 2008 as substantially equivalent to K053371 (American Medical Systems, Inc., 2006) after a 37-day review. Its family tree reaches back 10 generations to 1993. 5 later devices descend from it.
- Decided
- Oct 17, 2008
- Review
- 37 days
- Class
- Class II
- Product code
- OTM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K931386 (1993). 32 ancestors in all, the oldest K920213 (1992). 5 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 6 generations between
- 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 1 generation backK053371 Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 2006 · Recalled
- This deviceK082640 Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC · 2008
- Descendant · cites it directly · 4 of its ownK091152 Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S · 2009
- Descendant · cites it directly · 3 of its ownK101297 Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S · 2010
- Descendant · 2 generations on · 1 of its ownK113496 Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S · 2012
- Descendant · 3 generations on · 0 of its ownK231891 Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast · 2023
- Descendant · 2 generations on · 0 of its ownK111881 Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S · 2011
Show all 10 generations
- Root · 10 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 8 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 7 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 6 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 5 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 4 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 3 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 2 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 1 generation backK053371 Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 2006 · Recalled
- This deviceK082640 Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC · 2008
Most influential descendants
Showing 5 of 5 · See all- K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S · 2009 · cites it directly4descendants
- K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S · 2010 · cites it directly3descendants
- K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S · 2012 · 2 generations on1descendant
- K231891Virtue Male Sling System with Alexis Wound Retractor Convenience KitColoplast · 2023 · 3 generations on0descendants
- K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −9 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −8 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −7 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −6 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −5 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −4 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −3 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −2 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −1 | K053371 | Ams Male Transobturator Sling System | American Medical Systems, Inc. | 2006 | 3 |
| 0 (this device) | K082640 | Virtue Ventral Urethral Elevation Sling System | Coloplast Manufacturing Us, LLC | 2008 | — |
| +1 | K091152 | Virtue Ventral Urethral Elevation Sling System, Model 50020 | Coloplast A/S | 2009 | — |
| +1 | K101297 | Virtue Ventral Urethral Elevation Sling System Model 50020 | Coloplast A/S | 2010 | — |
| +2 | K113496 | Virture Male Sling System with Alexis Wound Retractor Convenience Kit | Coloplast A/S | 2012 | — |
| +3 | K231891 | Virtue Male Sling System with Alexis Wound Retractor Convenience Kit | Coloplast | 2023 | — |
| +2 | K111881 | Virtue Male Sling System and Alexis (R) Wound Retractor Kit | Coloplast A/S | 2011 | — |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2023 | 1 | 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
- #3 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 |
|---|---|---|---|
| * | K053371 | Ams Male Transobturator Sling SystemSummary page 1…quivalent in performance, indications, design and materials to American Medical Systems (AMS) AdVance Male Sling System cleared under premarket notification number K053371. Description Of The Device: The Coloplast VIRTUE Ventral Urethral Elevation Sling System consists of a polypropylene… | 2006 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 32 ancestors have a recall of any class.
- Of its descendants, K091152 (Coloplast A/S, 2009) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K053371.
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. 2008, 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 Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082640 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082640: Virtue Ventral Urethral Elevation Sling System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082640
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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