# K031925: Proceed Trilaminate Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Sep 17, 2003 after 86 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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 Polypropylene Mesh: named in the summary without a submission number

## Most influential descendants
- K093932: Ethicon Physiomesh, Flexible Composite Mesh (2010), 5 descendants of its own
- K152609: GORE SYNECOR Biomaterial (2015), 3 descendants of its own
- K173333: GORE ENFORM Biomaterial (2018), 1 descendant of its own
- K222919: GORE® ENFORM Biomaterial (2022), 0 descendants of its own
- K163576: GORE SYNECOR Preperitoneal Biomaterial (2017), 0 descendants of its own

## Recalls of this device
- Jan 4, 2006 · Not classified · Z-0449-06: Lots of Proceed Surgical Mesh may delaminate from the polypropylene mesh during certain hernia repairs. Exposure of the polypropylene layer to the bowel prior to reperitonealization could increase the

## Indications for use
PROCEED Mesh may be used for the repair of hernias and other fascial deficiencies that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K031925
Methodology: https://510kreport.com/methodology