# K061533: Proceed Ventral Patch

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Dec 11, 2006 after 192 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
No predicates in its family tree.
16 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) PROLENE* Soft Mesh: named in the summary without a submission number
- (no number) PROCEED* Mesh: named in the summary without a submission number
- (no number) BARD Ventralex & Small Ventralex Hernia Patch: named in the summary without a submission number
- (no number) VICRYL* Mesh: named in the summary without a submission number
- (no number) ETHIBOND* Polyester Suture: named in the summary without a submission number

## 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
PROCEED Ventral Patch is intended for the repair of hernias or other abdominal fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. PROCEED Ventral Patch is also indicated for the repair of tissue deficiencies caused by trocar use.

Source page: https://510kreport.com/device/K061533
Methodology: https://510kreport.com/methodology