# K113229: Ventrio Light Hernia Patch with TRM Antimicrobial Coating

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Jul 20, 2012 after 261 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: 11 generations back to K921895 (1992). 80 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 84 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081777: Ventrio Hernia Patch, C.R. Bard, Inc. (2008) Summary page 1.
- K100229: Ventrio Hernia Patch, C.R. Bard, Inc. (2010) Summary page 1.
- K053656: Tyrx Antimicrobial Mesh, Tyrx Pharma, Inc. (2006) Summary page 1.
- K093524: Pivit a/B ST and Pivit a/B ST-R, Tyrx, Inc. (2010) Summary page 1.

## Most influential descendants
- K133223: Xenmatrix AB Surgical Graft (2014), 2 descendants of its own
- K151177: XenMatrix AB Surgical Graft (2015), 1 descendant of its own
- K162193: XenMatrix AB Surgical Graft (2016), 0 descendants of its own

## Indications for use
The VentrioTM Light Hernia Patch is indicated for use in the reconstruction of soft tissue in procedures involving soft tissue repair where weakness exists, such as for the repair of hernias. TRM Antimicrobial Coating has been shown to reduce or inhibit microbial colonization on the device.

Source page: https://510kreport.com/device/K113229
Methodology: https://510kreport.com/methodology