# K081069: Gore Infinit Mesh

- Pathway: 510(k) (Abbreviated)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 30, 2008 after 45 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 K992189 (1999). 2 ancestors in all.
21 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992189: Gore-Tex Dualmesh Biomaterial, W. L. Gore & Associates, Inc. (1999) Summary page 1.
- K001122: Prolene Soft (Polypropylene), Nonabsorbabale Synthetic Surgical Mesh, ETHICON, Inc. (2000) 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
- K152609: GORE SYNECOR Biomaterial (2015), 3 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

## Indications for use
GORE INFINIT Mesh is indicated for use in the reconstruction of hernias and other soft tissue deficiencies.

Source page: https://510kreport.com/device/K081069
Methodology: https://510kreport.com/methodology