# K150341: Miromatrix Biological Mesh RS

- Pathway: 510(k) (Traditional)
- Applicant: Miromatrix Medical, Inc.
- Decided: May 12, 2015 after 90 days
- Product code: OXH (Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery)
- 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 K921895 (1992). 7 ancestors in all.
1 later device descends 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)
- K134033: Miromatrix Biological Mesh, Miromatrix Medical, Inc. (2014) Summary page 4.

## Most influential descendants
- K160400: Miromatrix Biological Mesh (2016), 0 descendants of its own

## Indications for use
The Miromatrix Biological Mesh RS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery.

Source page: https://510kreport.com/device/K150341
Methodology: https://510kreport.com/methodology