# K092207: Restorelle Polypropylene Mesh

- Pathway: 510(k) (Special)
- Applicant: Mpathy Medical Devices, Inc.
- Decided: Aug 4, 2009 after 13 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: 10 generations back to K931386 (1993). 32 ancestors in all.
13 later devices descend from it; 4 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041632: Minimesh Polypropylene Mesh, Mpathy Medical Devices, Ltd. (2004) Summary page 1.
- K053361: Modification to: Minimesh Polypropylene Mesh, Mpathy Medical Devices, Ltd. (2006) Summary page 1.
- K010931: Ams Sacral Colpopexy Sling, Model 72403501, American Medical Systems, Inc. (2001) Summary page 1.
- K071512: Gynecare Prolift +M* Pelvic Floor Repair Systems, ETHICON, Inc. (2008) Summary page 1.

## Most influential descendants
- K112322: Restorelle Polypropylene Y Mesh (2012), 6 descendants of its own
- K103426: Lite Pelvic Floor Repair Kits (2011), 4 descendants of its own
- K123914: Restorelle Y Contour (2013), 2 descendants of its own
- K122459: Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support System (2012), 2 descendants of its own
- K172060: Capio SLIM Suture Capturing Device (2017), 1 descendant of its own

## Indications for use
RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.

Source page: https://510kreport.com/device/K092207
Methodology: https://510kreport.com/methodology