# K081777: Ventrio Hernia Patch

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Sep 29, 2008 after 98 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K003323 (2001). 7 ancestors in all.
14 later devices descend from it; 7 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061314: Bard Extra Large Composix Kugel  Hernia Patch, Davol Inc., Sub. C. R. Bard, Inc. (2006) Summary page 1.
- K061533: Proceed Ventral Patch, ETHICON, Inc. (2006) Summary page 1.
- K081069: Gore Infinit Mesh, W. L. Gore & Associates, Inc. (2008) Summary page 1.
- K022782: Dualmesh Emerge & Emerge Plus Biomaterial, W. L. Gore & Associates, Inc. (2002) Summary page 1.

## Most influential descendants
- K100229: Ventrio Hernia Patch (2010), 13 descendants of its own
- K113229: Ventrio Light Hernia Patch with TRM Antimicrobial Coating (2012), 3 descendants of its own
- K101920: Ventrio ST Hernia Patch (2011), 3 descendants of its own
- K133223: Xenmatrix AB Surgical Graft (2014), 2 descendants of its own
- K190185: Phasix ST Mesh with Open Positioning System (2019), 1 descendant of its own

## Recalls of this device
- Oct 15, 2010 · Not classified · Z-0422-2011: Mislabeled: Hernia Patch may be a different size than on the product label
- Oct 15, 2010 · Not classified · Z-0423-2011: Mislabeled: Hernia Patch may be a different size than on the product label
- Oct 15, 2010 · Not classified · Z-0424-2011: Mislabeled: Hernia Patch may be a different size than on the product label
- Apr 8, 2010 · Not classified · Z-1536-2010: Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0")

## Indications for use
The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Source page: https://510kreport.com/device/K081777
Methodology: https://510kreport.com/methodology