# K134033: Miromatrix Biological Mesh

- Pathway: 510(k) (Traditional)
- Applicant: Miromatrix Medical, Inc.
- Decided: Mar 31, 2014 after 90 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: 3 generations back to K921895 (1992). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980431: Surgisis, Cook Biotech, Inc. (1998) Summary page 1.

## Most influential descendants
- K150341: Miromatrix Biological Mesh RS (2015), 1 descendant of its own
- K160400: Miromatrix Biological Mesh (2016), 0 descendants of its own

## Indications for use
The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue.

Source page: https://510kreport.com/device/K134033
Methodology: https://510kreport.com/methodology