# K082677: Ams Elevate Anterior & Apical Prolapse Repair System with Intepro Lite

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems, Inc.
- Decided: Dec 23, 2008 after 99 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931386 (1993). 39 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051485: Ams Pelvic Floor Repair System, American Medical Systems, Inc. (2005) Summary page 1.

## Most influential descendants
- K121612: Elevate Prolapse Repair Systems-Apical Needle Passer Sheath Modification (2012), 0 descendants of its own

## Recalls of this device
- May 9, 2011 · Not classified · Z-2755-2011: 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 r

## Indications for use
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.

Source page: https://510kreport.com/device/K082677
Methodology: https://510kreport.com/methodology