# K112322: Restorelle Polypropylene Y Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Coloplast A/S
- Decided: May 17, 2012 after 279 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K931386 (1993). 36 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101722: Alyte Y-Mesh Graft, C.R. Bard, Inc. (2011) Summary page 1.
- K092207: Restorelle Polypropylene Mesh, Mpathy Medical Devices, Inc. (2009) Summary page 1.

## Most influential descendants
- K123914: Restorelle Y Contour (2013), 2 descendants of its own
- K140116: Restorelle Y Contour Mesh (2014), 1 descendant of its own
- K123028: Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-Mesh (2013), 1 descendant of its own
- K173501: Meridian Vaginal Positioning System (VPS) (2018), 0 descendants of its own
- K150023: Vertessa Lite Y-Mesh (2015), 0 descendants of its own

## Indications for use
Restorelle Y is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Source page: https://510kreport.com/device/K112322
Methodology: https://510kreport.com/methodology