# K060713: Proceed Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: May 25, 2006 after 69 days
- Product code: FTL (Mesh, Surgical, Polymeric)
- Device class: 2
- Regulation: 21 CFR 878.3300
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
9 later devices descend from it; 3 cite it directly.
0 of 10 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) PROCEED Trilaminate Surgical 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
- K093123: Biomerix Ventral Hernia Repair Mesh, Model SM3-Tab (2010), 1 descendant of its own
- K222919: GORE® ENFORM Biomaterial (2022), 0 descendants of its own

## Recalls of this device
- Oct 23, 2020 · Class II · Z-0533-2021: The firm is recalling the PROCEED Surgical Mesh device, because it is a sterile device, and a customer found a hair inside of the primary packaging of a single unit.
- Feb 19, 2014 · Class II · Z-1329-2014: The possibility exists that an incomplete seal on the packaging compromised the sterility of the device and introduced the potential for delamination.
- Oct 18, 2010 · Not classified · Z-0903-2011: There is a potential for delamination in one lot of Proceed surgical mesh.

## Indications for use
PROCEED Surgical 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/K060713
Methodology: https://510kreport.com/methodology