# K093123: Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab

- Pathway: 510(k) (Traditional)
- Applicant: Biomerix Corporation
- Decided: May 13, 2010 after 223 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: 10 generations back to K921895 (1992). 87 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082941: Biomerix Composite Surgical Mesh, Model SMNR-0510 and SMNR-1215, Biomerix Corporation (2009) Summary page 1.
- K060713: Proceed Surgical Mesh, ETHICON, Inc. (2006) Summary page 1.
- K072974: Surgimesh XB, Aspide Medical (2008) Summary page 1.
- K062558: Mesosfol Surgical Film, Biomet Manufacturing Corp (2007) Summary page 1.
- K050332: Surgi-Wrap Mast Bioresorbable Sheet, Mast Biosurgery USA, Inc. (2005) Summary page 1.
- K042811: Vivosorb Sheet, Model FS01, Polyganics B.V., (2004) Summary page 1.

## Most influential descendants
- K112567: Biomerix Assure (2011), 0 descendants of its own

## Indications for use
The Biomerix Ventral Hernia Repair Mesh is intended for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. the resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.

Source page: https://510kreport.com/device/K093123
Methodology: https://510kreport.com/methodology