# K232924: T-Line® Hernia Mesh

- Pathway: 510(k) (Special)
- Applicant: Deep Blue Medical Advances, Inc.
- Decided: Oct 18, 2023 after 29 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: 4 generations back to K052155 (2005). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230227: T-Line Hernia Mesh, Deep Blue Medical Advances, Inc. (2023) Summary page 5.
- K221556: T-Line Hernia Mesh, Deep Blue Medical Advances, Inc. (2022) Summary page 5.
- K193144: T-Line Hernia Mesh, Deep Blue Medical Advances, Inc. (2020) Summary page 5.

## Indications for use
The T-Line Hernia Mesh is indicated for the reinforcement of soft tissue where weakness exists for the repair of ventral hernias performed via an open onlay or sub lay approach in adults (greater than 21 years of age).

Source page: https://510kreport.com/device/K232924
Methodology: https://510kreport.com/methodology