# K120327: Vertessa

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: May 10, 2012 after 98 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). 27 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101462: Ascend Blue AC Mesh; Ascend Blue PC Mesh, Caldera Medical, Inc. (2010) Summary page 1.
- K053424: Popmesh, Caldera Medical, Inc. (2006) Summary page 1.

## Most influential descendants
- K123337: Vertessa Lite 10 X 20CM, Vertessa Lite 11 X 30CM (2013), 1 descendant of its own
- K122440: Restorelle L (2012), 1 descendant of its own
- K150016: Vertessa Lite (2015), 0 descendants of its own
- K132061: Restorelle M, Restorelle XL (2013), 0 descendants of its own
- K122968: Novasilk Mesh Qty 1 Model 93-6014, Novasilk Mesh Qty 3 Model 93-6015 (2012), 0 descendants of its own

## Indications for use
Vertessa TM may be used for the repair of uterine or vaginal vault prolapse that requires support material. It may be used in open or lapamoscopic abdominal procedures.

Source page: https://510kreport.com/device/K120327
Methodology: https://510kreport.com/methodology