# K103568: Restorelle Polypropylene Mesh; Restorelle Polypropylene Mesh

- Pathway: 510(k) (Special)
- Applicant: Coloplast A/S
- Decided: Dec 22, 2010 after 16 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931386 (1993). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092207: Restorelle Polypropylene Mesh, Mpathy Medical Devices, Inc. (2009) Summary page 1.
- 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.

## Recalls of this device
- Mar 2, 2012 · Not classified · Z-1481-2012: Coloplast is conducting a field correction based on the conclusion that two lots of Restorelle DirectFix Posterior mesh were mislabeled. The incorrect size was printed on the patient label. Specifical

## 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/K103568
Methodology: https://510kreport.com/methodology