510(k) · Cleared
ClearedAms Triangle Silicone-Coated Sling and Surgical Mesh
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems, Inc. · FTL Mesh, Surgical, Polymeric
Cleared on Nov 29, 2000 as substantially equivalent to K980482 (Influence, Inc., 1998) and 3 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1993. 113 later devices descend from it.
- Decided
- Nov 29, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- FTL
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K931386 (1993). 8 ancestors in all, the oldest K922916 (1992). 113 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 3 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 2 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 1 generation backK980482 Triangle SlingInfluence, Inc. · 1998
- This deviceK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- Descendant · cites it directly · 80 of its ownK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- Descendant · 2 generations on · 79 of its ownK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- Descendant · 3 generations on · 74 of its ownK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- Descendant · 3 generations on · 70 of its ownK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- Descendant · 3 generations on · 70 of its ownK040537 Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004
Showing 5 of 113 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 113 · See all- K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001 · cites it directly80descendants
- K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003 · 2 generations on79descendants
- K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004 · 3 generations on74descendants
- K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004 · 3 generations on70descendants
- K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004 · 3 generations on70descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −3 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −2 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −1 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| 0 (this device) | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| +1 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| +2 | 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 | — |
| +3 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| +3 | K040537 | Ams Apogee Vault Suspension System | American Medical Systems, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 13 | 0 |
| 2009 | 9 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 14 | 0 |
| 2013 | 9 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 6 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 FTL? 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 FTL device
- #1 K220091 Poly-Tape/Infinity-Lock Soft Tissue…score 16.8 · 14 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 |
|---|---|---|---|
| * | K980482 | Triangle SlingSummary page 1…FTL Classification: Class II Manufacturing Location: ‘ Predicate American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Devices: TriAngle™ Sling - K980482 Bard® Marlex Mesh - K922916 Ethicon™ Prolene™ Mesh - K962530 Mersilene™ Mesh _ Mentor SUSPEND™ Sling - K980483 Indications for… | 1998 |
| * | K922916 | Bard Marlex Mesh DartSummary page 1…Manufacturing Location: ‘ Predicate American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Devices: TriAngle™ Sling - K980482 Bard® Marlex Mesh - K922916 Ethicon™ Prolene™ Mesh - K962530 Mersilene™ Mesh _ Mentor SUSPEND™ Sling - K980483 Indications for Use: The AMS Triangle™ Silic… | 1992 |
| * | K962530 | Prolene Polypropylene Mesh Nonabsorbable Synthetic Surgical MeshSummary page 1…icate American Medical Systems, Inc. 10700 Bren Rd. West Minnetonka, MN 55343 Devices: TriAngle™ Sling - K980482 Bard® Marlex Mesh - K922916 Ethicon™ Prolene™ Mesh - K962530 Mersilene™ Mesh _ Mentor SUSPEND™ Sling - K980483 Indications for Use: The AMS Triangle™ Silicone-Coated Sling and Surgical Mes… | 1996 |
| * | K980483 | Mentor Suspend SlingSummary page 1…d. West Minnetonka, MN 55343 Devices: TriAngle™ Sling - K980482 Bard® Marlex Mesh - K922916 Ethicon™ Prolene™ Mesh - K962530 Mersilene™ Mesh _ Mentor SUSPEND™ Sling - K980483 Indications for Use: The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment… | 1998 |
| * | — | Mersilene™ Mesh Named without a submission number |
What descends from it? (113)
See all 1134 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 7 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K010931 (American Medical Systems, Inc., 2001) has gone furthest, with 80 descendants of its own.
How does its category compare?
All FTL devicesFTL Mesh, Surgical, Polymeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FTL
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FTL
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FTL
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FTL
3,487in 2025
MAUDE reports naming product code FTL, 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 | 20 | 92 | 2 | 1,737 |
| 2008 | 23 | 114 | 1 | 1,569 |
| 2009 | 15 | 97 | 1 | 1,906 |
| 2010 | 18 | 132 | 12 | 2,175 |
| 2011 | 15 | 90 | 8 | 3,608 |
| 2012 | 12 | 213 | 2 | 14,700 |
| 2013 | 8 | 90 | 1 | 26,519 |
| 2014 | 11 | 70 | 3 | 2,683 |
| 2015 | 12 | 121 | 0 | 2,526 |
| 2016 | 3 | 186 | 0 | 2,417 |
| 2017 | 6 | 132 | 1 | 3,947 |
| 2018 | 12 | 105 | 1 | 11,893 |
| 2019 | 4 | 99 | 0 | 21,724 |
| 2020 | 5 | 138 | 1 | 18,819 |
| 2021 | 2 | — | 0 | 16,284 |
| 2022 | 6 | 195 | 0 | 11,439 |
| 2023 | 4 | 29 | 0 | 8,025 |
| 2024 | 2 | — | 0 | 8,565 |
| 2025 | 6 | 30 | 0 | 3,487 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The AMS Triangle™ Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic fleer and sacral-colposuspension.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K002721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002721
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026