# K060004: Caldera Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Caldera Medical, Inc.
- Decided: Feb 22, 2006 after 50 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- 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
No predicates in its family tree.
9 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## 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 Caldera Polypropylene Mesh is a mesh sling implant that is intended fbr the treatment of urinary incontinence resulting from urethral hypermobility or ISD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair. reconstruction of the pelvic floor and sacral-colposuspension.

Source page: https://510kreport.com/device/K060004
Methodology: https://510kreport.com/methodology