# K111121: Vitamesh (TM) Blue Lightweight Macroporous PP Surgical Mesh

- Pathway: 510(k) (Special)
- Applicant: Proxy Biomedical, Ltd.
- Decided: May 13, 2011 after 22 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
Longest line of descent: 1 generation back to K060520 (2006). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060520: Vitamesh Macroporous PP Surgical Mesh, Proxy Biomedical, Ltd. (2006) Summary page 1.

## Indications for use
VitaMeshTm Blue Lightweight Macroporous PP Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.

Source page: https://510kreport.com/device/K111121
Methodology: https://510kreport.com/methodology