510(k) · Cleared
Recalled · Class II · 2014Ams Male Transobturator Sling System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems, Inc. · OTM Mesh, Surgical, For Stress Urinary Incontinence, Male
Cleared on Feb 3, 2006 as substantially equivalent to K982155 (Influence, Inc., 1998) and 4 other predicates after a 60-day review. Its family tree reaches back 9 generations to 1993. 10 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 3, 2006
- Review
- 60 days
- Class
- Class II
- Product code
- OTM
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 9 generations to K931386 (1993). 31 ancestors in all, the oldest K920213 (1992). 10 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 5 generations between
- 3 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 2 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 1 generation backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- This deviceK053371 Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK082640 Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC · 2008
- Descendant · 2 generations on · 4 of its ownK091152 Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S · 2009
- Descendant · 2 generations on · 3 of its ownK101297 Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S · 2010
- Descendant · cites it directly · 2 of its ownK182169 AdVance XP Male SlingBoston Scientific Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK211847 AdVance XP Male Sling SystemBoston Scientific Corporation · 2021
Show all 9 generations
- Root · 9 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 8 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 7 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 6 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 5 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 4 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 3 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 2 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 1 generation backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- This deviceK053371 Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 2006
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K082640Virtue Ventral Urethral Elevation Sling SystemColoplast Manufacturing Us, LLC · 2008 · cites it directly5descendants
- K091152Virtue Ventral Urethral Elevation Sling System, Model 50020Coloplast A/S · 2009 · 2 generations on4descendants
- K101297Virtue Ventral Urethral Elevation Sling System Model 50020Coloplast A/S · 2010 · 2 generations on3descendants
- K182169AdVance XP Male SlingBoston Scientific Corporation · 2018 · cites it directly2descendants
- K211847AdVance XP Male Sling SystemBoston Scientific Corporation · 2021 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −8 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −7 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −6 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −5 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −4 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −3 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −2 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −1 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| 0 (this device) | K053371 | Ams Male Transobturator Sling System | American Medical Systems, Inc. | 2006 | — |
| +1 | K082640 | Virtue Ventral Urethral Elevation Sling System | Coloplast Manufacturing Us, LLC | 2008 | — |
| +2 | 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 | K182169 | AdVance XP Male Sling | Boston Scientific Corporation | 2018 | — |
| +2 | K211847 | AdVance XP Male Sling System | Boston Scientific Corporation | 2021 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (5)
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 |
|---|---|---|---|
| * | K982155 | Short Straight-in Bone Screw Fixation SystemSummary page 1…Surgical Mesh, polymeric Predicate Devices: Short Shaft Straight-In Bone Fixation System (trade name "InVance) (K982155) Monarc Subfascial Hammock (K023 516). Sparc Sling System (… | 1998 |
| * | K023516 | Monarc Sling SystemSummary page 1…aft Straight-In Bone Fixation System (trade name "InVance) (K982155) Monarc Subfascial Hammock (K023 516). Sparc Sling System (KOI1 125 1) Apogee (K040537),… | 2002 |
| * | K011251 | Sparc Sling System | 2001 |
| * | K040537 | Ams Apogee Vault Suspension SystemSummary page 1…Monarc Subfascial Hammock (K023 516). Sparc Sling System (KOI1 125 1) Apogee (K040537), Perigee (K040623) and other devices D)ev ice Description The AMS Male TransobtUrator Sling… | 2004 |
| * | K040623 | Ams Perigee SystemSummary page 1…516). Sparc Sling System (KOI1 125 1) Apogee (K040537), Perigee (K040623) and other devices D)ev ice Description The AMS Male TransobtUrator Sling System consists of a sling and a surgical instrument (… | 2004 |
What descends from it? (10)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 15, 2014 | Class II | Z-0806-2015 | Nonconforming Material/Component | During routine periodic packaging testing, AMS identified that in simulated extreme shipping and handling situations the sterile barrier packaging of the Needle Passer components supplied with the AdVance" Male Sling System; Model #… |
| Oct 19, 2012 | Class II | Z-0259-2013 | Device Design | American Medical Systems (AMS) is issuing a voluntary recall on a number of lots of the AdVance Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not… |
| Sep 7, 2010 | Not classified | Z-0808-2011 | Package design/selection | American Medical Systems (AMS) is recalling all lots of the AdVance male Sling System with an expiration date between July 2012 and August 2013. Internal testing has indicated the potential for degradation of the bioabsorbable tensioning… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 5 of the 31 ancestors have a recall of any class.
- Of its descendants, K082640 (Coloplast Manufacturing Us, LLC, 2008) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K982155.
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.
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 AMS Male Transobturator Sling System is indicated for a sub-urethral sling implant to treat male stress urinary incontinence.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053371: Ams Male Transobturator 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/K053371
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