# K101928: Ventralex 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K971745 (1997). 19 ancestors in all.
1 later device descends from it; 1 cites 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.
- K021736: Bard Ventralex Hernia Patch, Models 0010302, 0010301, C.R. Bard, Inc. (2002) Summary page 1.
- K024008: Small Bard Ventralex Patch, C.R. Bard, Inc. (2003) Summary page 1.

## Most influential descendants
- K243241: Phasix ST Umbilical Hernia Patch (2025), 0 descendants of its own

## Recalls of this device
- Oct 4, 2011 · Not classified · Z-0144-2012: Mislabeled: Bard Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard Ventralex" ST Large Circle.

## Indications for use
The Ventralex 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 and deficiencies caused by trocars.

Source page: https://510kreport.com/device/K101928
Methodology: https://510kreport.com/methodology