# K101722: Alyte Y-Mesh Graft

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 1, 2011 after 287 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: 9 generations back to K931386 (1993). 23 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090739: Bard Sacrocolpopexy Graft, C.R. Bard, Inc. (2009) Summary page 1.
- K060004: Caldera Mesh, Caldera Medical, Inc. (2006) Summary page 1.
- K010931: Ams Sacral Colpopexy Sling, Model 72403501, American Medical Systems, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K173501: Meridian Vaginal Positioning System (VPS) (2018), 0 descendants of its own

## Indications for use
The ALYTE TM Y-Mesh Graft is indicated for use as a bridging material for sacrocolposuspension /sacrocolpopexy (laparotomy or laparoscopic approach) where surgical treatment for vaginal vault prolapse is warranted.

Source page: https://510kreport.com/device/K101722
Methodology: https://510kreport.com/methodology