# K060018: Trulene Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Sutures India Pvt., Ltd.
- Decided: Jul 26, 2006 after 203 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: 3 generations back to K945377 (1994). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K905655: Nonabsorbable Polypropylene Surgical Mesh, United States Surgical, A Division of Tyco Healthc (1990) Summary page 1.
- K041632: Minimesh Polypropylene Mesh, Mpathy Medical Devices, Ltd. (2004) Summary page 1.
- (no number) Ethicon: named in the summary without a submission number

## Indications for use
TRULENE MESH, NONABSORBABLE POLYPROPYLENE SURGICAL MESH IS INDICATED FOR USE IN HERNIA REPAIR 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/K060018
Methodology: https://510kreport.com/methodology