# K123028: Vertessa Lite 10 X20CM, Vertessa Lite 11 X 30CM, Vertessa Lite Y-Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Apr 25, 2013 after 209 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: 12 generations back to K931386 (1993). 37 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 39 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.
- K112322: Restorelle Polypropylene Y Mesh, Coloplast A/S (2012) Summary page 1.

## Most influential descendants
- K150023: Vertessa Lite Y-Mesh (2015), 0 descendants of its own

## Indications for use
VertessaIM Lite Y-Mesh may be used as a bridging material for sacrocolposuspension/sacrocolpopexy (laparotomy; laparoscopic, or robotically-assisted approach) where surgical treatment for vaginal vault prolapse is warranted.

Source page: https://510kreport.com/device/K123028
Methodology: https://510kreport.com/methodology