510(k) · Cleared
Recalled · 2011Ams Elevate Anterior & Apical Prolapse Repair System with Intepro Lite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems, Inc. · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Cleared on Dec 23, 2008 as substantially equivalent to K051485 (American Medical Systems, Inc., 2005) after a 99-day review. Its family tree reaches back 11 generations to 1993. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 23, 2008
- Review
- 99 days
- Class
- Class III
- Product code
- OTP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K931386 (1993). 39 ancestors in all, the oldest K830889 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 7 generations between
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 1 generation backK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- This deviceK082677 Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK121612 Elevate Prolapse Repair Systems-Apical Needle Passer Sheath…American Medical Systems · 2012
Show all 11 generations
- Root · 11 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 9 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 8 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 7 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 6 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 5 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 4 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 3 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 2 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 1 generation backK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- This deviceK082677 Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteAmerican Medical Systems, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K121612Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationAmerican Medical Systems · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −10 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −9 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −8 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −7 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −6 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −5 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −4 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −3 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −2 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| −1 | K051485 | Ams Pelvic Floor Repair System | American Medical Systems, Inc. | 2005 | — |
| 0 (this device) | K082677 | Ams Elevate Anterior & Apical Prolapse Repair System with Intepro Lite | American Medical Systems, Inc. | 2008 | — |
| +1 | K121612 | Elevate Prolapse Repair Systems-Apical Needle Passer Sheath Modification | American Medical Systems | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 OTP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K051485 | Ams Pelvic Floor Repair SystemSummary page 1…ntePro® Lite™ Device Classification/ Class I1, 21 CFR Part 878.3300 Classification Name: Surgical Mesh, polymeric {OTP) Predicate Device: AMS Pelvic Floor Repair System (K051485) Indications for Use The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to… | 2005 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121612 | Elevate Prolapse Repair Systems-Apical Needle Passer Sheath Modification | 2012 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 9, 2011 | Not classified | Z-2755-2011 | Process control | This is an important notification regarding the Elevate Anterior and Apical Prolapse Repair Systems, Part Number 720093-01, manufactured between August 3, 2010 and January 17, 2011. We have recently received complaints stating that the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 10 months on median.
- 4 of the 39 ancestors have a recall of any class.
- Of its descendants, K121612 (American Medical Systems, 2012) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K051485.
How does its category compare?
All OTP devicesOTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · OTP
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OTP
71in 2011
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OTP
No recall names OTP since 2007.
Adverse event reports per year · OTP
26in 2025
MAUDE reports naming product code OTP, 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 | 4 | 90 | 0 | 1 |
| 2008 | 8 | 103 | 0 | 0 |
| 2009 | 6 | 21 | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 5 | 71 | 0 | 32 |
| 2012 | 2 | — | 0 | 494 |
| 2013 | 0 | — | 0 | 7,150 |
| 2014 | 0 | — | 0 | 778 |
| 2015 | 0 | — | 0 | 684 |
| 2016 | 0 | — | 0 | 415 |
| 2017 | 0 | — | 0 | 273 |
| 2018 | 0 | — | 0 | 392 |
| 2019 | 0 | — | 0 | 368 |
| 2020 | 0 | — | 0 | 175 |
| 2021 | 0 | — | 0 | 647 |
| 2022 | 0 | — | 0 | 114 |
| 2023 | 0 | — | 0 | 59 |
| 2024 | 0 | — | 0 | 35 |
| 2025 | 0 | — | 0 | 26 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AMS Elevate System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological, and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.
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/K082677 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082677: Ams Elevate Anterior & Apical Prolapse Repair System with Intepro Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082677
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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