510(k) · Cleared
ClearedElevate Prolapse Repair Systems-Apical Needle Passer Sheath Modification
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Medical Systems · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Cleared on Jul 20, 2012 as substantially equivalent to K082677 (American Medical Systems, Inc., 2008) and 1 other predicate after a 49-day review. Its family tree reaches back 13 generations to 1993.
- Decided
- Jul 20, 2012
- Review
- 49 days
- Class
- Class III
- Product code
- OTP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K931386 (1993). 42 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 13 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 9 generations between
- 3 generations backK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- 2 generations backK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
- 1 generation backK082730 Ams Elevate Apical and Posterior Prolapse Repair System with Intepro…American Medical Systems, Inc. · 2008
- This deviceK121612 Elevate Prolapse Repair Systems-Apical Needle Passer Sheath…American Medical Systems · 2012
Show all 13 generations
- Root · 13 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 12 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 11 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 10 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 9 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 8 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 7 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 6 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 5 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 4 generations backK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled
- 3 generations backK051485 Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
- 2 generations backK080185 Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate…American Medical Systems, Inc. · 2008
- 1 generation backK082730 Ams Elevate Apical and Posterior Prolapse Repair System with Intepro…American Medical Systems, Inc. · 2008
- This deviceK121612 Elevate Prolapse Repair Systems-Apical Needle Passer Sheath…American Medical Systems · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −12 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −11 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −10 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −9 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −8 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −7 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −6 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −5 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −4 | K050445 | Ams Collagen Dermal Matrix | American Medical Systems, Inc. | 2005 | 1 |
| −3 | K051485 | Ams Pelvic Floor Repair System | American Medical Systems, Inc. | 2005 | — |
| −2 | K080185 | Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen… | American Medical Systems, Inc. | 2008 | — |
| −1 | K082730 | Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams… | American Medical Systems, Inc. | 2008 | — |
| 0 (this device) | 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 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K082677 | Ams Elevate Anterior & Apical Prolapse Repair System with Intepro LiteSummary page 2…) - Device Name - Submission Number AMS Elevate Anterior and Apical Prolapse Repair System with K082677 IntePro Lite AMS Elevate Apical and Posterior Prolapse Repair System with IntePro Lite AMS El… | 2008 |
| * | K082730 | Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate…Summary page 2…AMS Elevate Apical and Posterior Prolapse Repair System with IntePro Lite AMS Elevate Apical and Posterior Prolapse Repair System with K082730 InteXen LP Device Description Each Elevate System consists of a permanently-im… | 2008 |
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 19 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 5 of the 42 ancestors have a recall of any class.
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. 2012, 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?
Elevate Anterior and Apical Prolapse Repair System The Elevate Anterior &Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse. Elevate Apical and Posterior Prolapse Repair System The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse.…
Read the full statement (102 words)
Elevate Anterior and Apical Prolapse Repair System
The Elevate Anterior &Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior wall prolapse and vaginal apical prolapse.
Elevate Apical and Posterior Prolapse Repair System
The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior wall prolapse and vaginal apical prolapse.
Elevate Apical and Posterior Prolapse Repair System with InteXen4D LP
The Elevate Apical & Posterior Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct posterior vaginal wall prolapse and vaginal apical prolapse.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121612 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121612: Elevate Prolapse Repair Systems-Apical Needle Passer Sheath Modification.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121612
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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