# K121612: Elevate Prolapse Repair Systems-Apical Needle Passer Sheath Modification

- Pathway: 510(k) (Special)
- Applicant: American Medical Systems
- Decided: Jul 20, 2012 after 49 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: 13 generations back to K931386 (1993). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082677: Ams Elevate Anterior & Apical Prolapse Repair System with Intepro Lite, American Medical Systems, Inc. (2008) Summary page 2.
- K082730: Ams Elevate Apical and Posterior Prolapse Repair System with Intepro Lite, Ams Elevate Apical and Posterior Prolapse, American Medical Systems, Inc. (2008) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K121612
Methodology: https://510kreport.com/methodology