# K113205: Artisyn Y-Shaped Mesh

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jun 11, 2012 after 224 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). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 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.
- K082216: TBD Ethicon Mesh, ETHICON, Inc. (2008) Summary page 1.
- K092207: Restorelle Polypropylene Mesh, Mpathy Medical Devices, Inc. (2009) Summary page 1.

## Indications for use
ARTISYN™ Y-Shaped Mesh is indicated for use as a bridging material for sacrocolposuspension/sacrocolpopexy (laparatomy or laparéscopic approach) where surgical treatment for vaginal vault prolapse is warranted.

Source page: https://510kreport.com/device/K113205
Methodology: https://510kreport.com/methodology