# K162570: Miromatrix Biological Mesh TW

- Pathway: 510(k) (Traditional)
- Applicant: Miromatrix Medical, Inc.
- Decided: Feb 16, 2017 after 154 days
- Product code: FTM (Mesh, Surgical)
- 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 K000019 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites 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)
- K053655: Tendon Wrap Tendon Protector, Integra LifeSciences Corporation (2006) Summary page 4.

## Most influential descendants
- K250109: TYBR Collagen Gel (2025), 0 descendants of its own

## Indications for use
The Miromatrix Biological Mesh TW is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Source page: https://510kreport.com/device/K162570
Methodology: https://510kreport.com/methodology