# K033636: Ams Large Pore Polypropylene Mesh

- Pathway: 510(k) (Traditional)
- Applicant: American Medical Systems, Inc.
- Decided: Dec 31, 2003 after 42 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: 6 generations back to K931386 (1993). 12 ancestors in all.
79 later devices descend from it; 5 cite it directly.
0 of 92 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013718: Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair, Gynecare, A Div. of Ethicon, Inc. (2002) Summary page 1.
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh, ETHICON, Inc. (2000) Summary page 1.
- K010931: Ams Sacral Colpopexy Sling, Model 72403501, American Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- K040521: Modification to Ams Large Pore Polypropylene Mesh (2004), 74 descendants of its own
- K040623: Ams Perigee System (2004), 70 descendants of its own
- K040537: Ams Apogee Vault Suspension System (2004), 70 descendants of its own
- K050445: Ams Collagen Dermal Matrix (2005), 30 descendants of its own
- K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems (2008), 20 descendants of its own

## Indications for use
The AMS Large Pore Polypropylene Mesh is indicated for tissue reinforcement and long-lasting stabilization of fascial structures of the pelvic floor in vaginal wall prolapse where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.

Source page: https://510kreport.com/device/K033636
Methodology: https://510kreport.com/methodology