# K061314: Bard Extra Large Composix Kugel  Hernia Patch

- Pathway: 510(k) (Traditional)
- Applicant: Davol Inc., Sub. C. R. Bard, Inc.
- Decided: Jun 2, 2006 after 22 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: 1 generation back to K003323 (2001). 1 ancestor in all.
15 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003323: Composix Kugel Mesh, Model 0010201,0010202,0010203,0010204,0010205, Davol, Inc. (2001) Summary page 2.

## Most influential descendants
- K081777: Ventrio Hernia Patch (2008), 14 descendants of its own
- 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

## Indications for use
Bard Modified Extra Large Composix Kugel Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias and chest wall defects.

Source page: https://510kreport.com/device/K061314
Methodology: https://510kreport.com/methodology