# K101920: Ventrio ST Hernia Patch

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 23, 2011 after 257 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: 5 generations back to K971745 (1997). 17 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100229: Ventrio Hernia Patch, C.R. Bard, Inc. (2010) Summary page 1.
- K081777: Ventrio Hernia Patch, C.R. Bard, Inc. (2008) Summary page 1.
- K040868: Sepramesh IP Bioresorbable Barrier - Permanent Mesh, Genzyme Corp. (2004) Summary page 1.
- K053066: Sepramesh IP Bioresorbable Coating/Permanent Mesh, Genzyme Corporation (2005) Summary page 1.
- K063739: Sepramesh, Model 5959-1214, Genzyme Corporation (2007) Summary page 1.

## Most influential descendants
- K190185: Phasix ST Mesh with Open Positioning System (2019), 1 descendant of its own
- K243241: Phasix ST Umbilical Hernia Patch (2025), 0 descendants of its own
- K141560: Ethicon Physiomesh Open Flexible Composite Mesh Device (2014), 0 descendants of its own

## Indications for use
The Ventrio ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias.

Source page: https://510kreport.com/device/K101920
Methodology: https://510kreport.com/methodology