# K142706: Modified ONFLEX Mesh

- Pathway: 510(k) (Traditional)
- Applicant: C.R. Bard, Inc.
- Decided: Mar 25, 2015 after 184 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: 4 generations back to K003323 (2001). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091659: Bard 3DMAX Light Mesh, Models: 0117310, 0117311, 0117312, 0117320, 0117321, 011732, C.R. Bard, Inc. (2009) Summary page 4.
- K081777: Ventrio Hernia Patch, C.R. Bard, Inc. (2008) Summary page 4.
- K100229: Ventrio Hernia Patch, C.R. Bard, Inc. (2010) Summary page 4.
- K963141: Kugel Hernia Patch, Douglas Bueschel (1996) Summary page 4.

## Indications for use
The Modified ONFLEX Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.

Source page: https://510kreport.com/device/K142706
Methodology: https://510kreport.com/methodology