# K090739: Bard Sacrocolpopexy Graft

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Nov 10, 2009 after 235 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: 8 generations back to K931386 (1993). 21 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053361: Modification to: Minimesh Polypropylene Mesh, Mpathy Medical Devices, Ltd. (2006) Summary page 1.
- K033636: Ams Large Pore Polypropylene Mesh, American Medical Systems, Inc. (2003) Summary page 1.
- K040521: Modification to Ams Large Pore Polypropylene Mesh, American Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K101722: Alyte Y-Mesh Graft (2011), 8 descendants of its own
- K112322: Restorelle Polypropylene Y Mesh (2012), 6 descendants of its own
- 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

## Indications for use
The Alyte™ Y-Mesh Graft is 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/K090739
Methodology: https://510kreport.com/methodology