# K041632: Minimesh Polypropylene Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Mpathy Medical Devices, Ltd.
- Decided: Nov 17, 2004 after 154 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K945377 (1994). 8 ancestors in all.
27 later devices descend from it; 6 cite it directly.
0 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh, ETHICON, Inc. (2000) Summary page 1.
- K905655: Nonabsorbable Polypropylene Surgical Mesh, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.
- K020110: Modification to Trelex Mesh Surgical Mesh, Boston Scientific (2002) Summary page 1.
- K013718: Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical Mesh for Pelvic Floor Repair, Gynecare, A Div. of Ethicon, Inc. (2002) Summary page 1.

## Most influential descendants
- K053361: Modification to: Minimesh Polypropylene Mesh (2006), 16 descendants of its own
- K092207: Restorelle Polypropylene Mesh (2009), 13 descendants of its own
- K090739: Bard Sacrocolpopexy Graft (2009), 9 descendants of its own
- K101722: Alyte Y-Mesh Graft (2011), 8 descendants of its own
- K112322: Restorelle Polypropylene Y Mesh (2012), 6 descendants of its own

## 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
MINIMESH® polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional 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/K041632
Methodology: https://510kreport.com/methodology