# K160400: Miromatrix Biological Mesh

- Pathway: 510(k) (Special)
- Applicant: Miromatrix Medical, Inc.
- Decided: Jun 8, 2016 after 117 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: 5 generations back to K921895 (1992). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150341: Miromatrix Biological Mesh RS, Miromatrix Medical, Inc. (2015) Summary page 4.

## Indications for use
The Miromatrix Biological Mesh is intended to be implanted to reinforce soft tissue and is also intended 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/K160400
Methodology: https://510kreport.com/methodology