# K181268: PROLENE (Polypropylene) 3D Patch

- Pathway: 510(k) (Traditional)
- Applicant: ETHICON, Inc.
- Decided: Jul 26, 2018 after 73 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 K010722 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010722: Prolene (Polypropylene) 3D Patch, Nonabsorbable Synthetic Surgical Mesh, ETHICON, Inc. (2001) Summary page 5.

## Indications for use
The PROLENE™ 3D Patch is indicated for the repair of groin hernia defects that require a reinforcing material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K181268
Methodology: https://510kreport.com/methodology