# K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: May 15, 2008 after 346 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: 9 generations back to K931386 (1993). 24 ancestors in all.
20 later devices descend from it; 5 cite it directly.
0 of 45 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.
- K033337: Ultrapro Mesh, ETHICON, Inc. (2004) Summary page 1.
- 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.

## Most influential descendants
- K092207: Restorelle Polypropylene Mesh (2009), 13 descendants of its own
- K112322: Restorelle Polypropylene Y Mesh (2012), 6 descendants of its own
- K081048: Pinnacle Pelvic Floor Repair Kit II (2008), 6 descendants of its own
- K091131: Pelvic Floor Repair System (2009), 5 descendants of its own
- K103426: Lite Pelvic Floor Repair Kits (2011), 4 descendants of its own

## Indications for use
The GYNECARE PROLIFT* Total, Anterior, and Posterior Pelvic Floor Repair Systems are 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. The GYNECARE PROLIFT+M* Total, Anterior, and Posterior Pelvic Floor Repair Systems, through the placement of GYNECARE GYNEMESH M* Partially Absorbable Mesh, are 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/K071512
Methodology: https://510kreport.com/methodology