# K191749: TIGR Matrix Surgical Mesh, TIGR Surgical Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Novus Scientific AB
- Decided: Mar 26, 2020 after 269 days
- Product code: OWT (Mesh, Surgical, Absorbable, Abdominal Hernia)
- 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: 6 generations back to K002699 (2001). 14 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161424: Phasix Mesh, C.R. Bard, Inc. (2016) Summary page 4.

## Most influential descendants
- K233661: Transorb™ Self-Gripping Resorbable Mesh (2024), 0 descendants of its own

## Indications for use
The TIGR Matrix Surgical Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repair of hernias or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.

Source page: https://510kreport.com/device/K191749
Methodology: https://510kreport.com/methodology