# K191545: Exogenesis Hernia Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Exogenesis Corporation
- Decided: Sep 26, 2019 after 107 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: 2 generations back to K962530 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180829: PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh, ETHICON, Inc. (2018) Summary page 4.

## Indications for use
The Exogenesis Hernia Mesh is indicated for the repair of abdominal wall hernias and abdominal wall deficiencies that require the addition of reinforcing material to obtain the desired surgical result. The Exogenesis Hernia Mesh is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). The Exogenesis Hernia Mesh is not indicated for transvaginal pelvic organ prolapse repair. The Exogenesis Hernia Mesh is intended for single patient one-time use only.

Source page: https://510kreport.com/device/K191545
Methodology: https://510kreport.com/methodology