# K111118: Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System with Intepro Lite

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems
- Decided: Jul 1, 2011 after 71 days
- Product code: OTP (Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed)
- Device class: 3
- Regulation: 21 CFR 884.5980
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K090713 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090713: Elevate Prolapse Repair System with PC Coated Intepro Lite- Apical and Posterior Prolapse Repair System, Anterior and AP, American Medical Systems, Inc. (2009) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K111118
Methodology: https://510kreport.com/methodology