# K221556: T-Line Hernia Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Deep Blue Medical Advances, Inc.
- Decided: Nov 28, 2022 after 181 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 K052155 (2005). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193144: T-Line Hernia Mesh, Deep Blue Medical Advances, Inc. (2020) Summary page 4.

## Most influential descendants
- K230227: T-Line Hernia Mesh (2023), 1 descendant of its own
- K232924: T-Line® Hernia Mesh (2023), 0 descendants of its own

## 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 sublay approach in adults (greater than 21 years of age).

Source page: https://510kreport.com/device/K221556
Methodology: https://510kreport.com/methodology