# K051485: Ams Pelvic Floor Repair System

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Aug 3, 2005 after 58 days
- Product code: OTO (Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K931386 (1993). 38 ancestors in all.
17 later devices descend from it; 5 cite it directly.
0 of 56 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040537: Ams Apogee Vault Suspension System, American Medical Systems, Inc. (2004) Summary page 1.
- K040623: Ams Perigee System, American Medical Systems, Inc. (2004) Summary page 1.
- K050445: Ams Collagen Dermal Matrix, American Medical Systems, Inc. (2005). Cleared while this submission was under review Summary page 1.
- K021263: Modification to Sparc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K023516: Monarc Sling System, American Medical Systems, Inc. (2002) Summary page 1.
- K002721: Ams Triangle Silicone-Coated Sling and Surgical Mesh, American Medical Systems, Inc. (2000) Summary page 1.
- K040521: Modification to Ams Large Pore Polypropylene Mesh, American Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K080185: Ams Elevate with Intepro Lite Prolapse Repair System, Ams Elevate with Intexen LP Prolapse Repair System (2008), 11 descendants of its own
- K090288: Orthadapt PR (2009), 7 descendants of its own
- K112786: Proseries Bioimplants-Proankle/Procuff (2011), 5 descendants of its own
- K220091: Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device (2022), 4 descendants of its own
- K251063: TekBrace Solo Soft Tissue Reinforcement Device (2025), 2 descendants of its own

## Indications for use
The AMS Pelvic Floor Repair 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 for the treatment of incontinence, 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/K051485
Methodology: https://510kreport.com/methodology