510(k) · Cleared

Cleared

Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System with Intepro Lite

K111118510(k) SpecialCleared Jul 1, 201171-day reviewClass III21 CFR 884.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

American Medical Systems · OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed

Cleared on Jul 1, 2011 as substantially equivalent to K090713 (American Medical Systems, Inc., 2009) after a 71-day review. Its family tree reaches back 1 generation to 2009.

Decided: Jul 1, 2011
Review: 71 days
Class: Class III
Product code: OTP
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K090713 (2009). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK090713 Elevate Prolapse Repair System with PC Coated Intepro Lite- Apical…American Medical Systems, Inc. · 2009
This deviceK111118 Ams Elevate PC Apical and Posterior ( and Anterior and Apical)…American Medical Systems · 2011

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K090713	Elevate Prolapse Repair System with PC Coated Intepro Lite- Apical and…	American Medical Systems, Inc.	2009	—
0 (this device)	K111118	Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair…	American Medical Systems	2011	—

FIG. 1 — Lineage of K111118, 2009–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K090713	Elevate Prolapse Repair System with PC Coated Intepro Lite- Apical and Posterior… Summary page 2 …prolapse transvaginally placed (OP") . Page 15 of 54 KA ' Pagc 2[?_ Predicate Device: AMS Elevate Prolapse Repair Systems with PC Coated IntePro Lite (K090713) Indications for Use: The indication for use for the AMS Elevate PC Prolapse Repair System has been revised from a general indi…	American Medical Systems, Inc.	2009	—

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?

Its one ancestor has no recall.

How does its category compare?

All OTP devices

OTP Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OTP

2in 2012

2007high 8 (2008) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTP

71in 2011

2007high 103 (2008) · low 21 (2009)2026

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

2007high 7,150 (2013) · low 0 (2008)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	MAUDE reports
2007	4	90	1
2008	8	103	0
2009	6	21	3
2010	0	—	3
2011	5	71	32
2012	2	—	494
2013	0	—	7,150
2014	0	—	778
2015	0	—	684
2016	0	—	415
2017	0	—	273
2018	0	—	392
2019	0	—	368
2020	0	—	175
2021	0	—	647
2022	0	—	114
2023	0	—	59
2024	0	—	35
2025	0	—	26
2026	0	—	—

What is it indicated for?

The Elevate PC Anterior & Apical Repair System is a surgical mesh kit intended for transvaginal surgical treatment to correct anterior vaginal wall prolapse and vaginal apical prolapse. The kit includes instrumentation for transvaginal placement.

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/K111118 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111118: Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System with Intepro Lite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111118

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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