# K161067: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”

- Pathway: 510(k) (Traditional)
- Applicant: Engineered Tissue Solutions, LLC
- Decided: Sep 15, 2016 after 153 days
- Product code: QSZ (Absorbable Synthetic Wound Dressing)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K842066 (1985). 77 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 81 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071552: Puracol Plus AG Collagen Microscaffold Wound Dressing, Medline Industries, Inc. (2008) Summary page 5.
- K132397: Gore Bio-a Wound Matrix, W. L. Gore & Associates, Inc. (2014) Summary page 5.

## Most influential descendants
- K222189: SiOxD Wound Matrix (2022), 2 descendants of its own
- K232847: SiOxD Wound Matrix (2023), 1 descendant of its own
- K241660: SiOxD® Wound Matrix (2024), 0 descendants of its own

## Indications for use
The Mirragen™ Advanced Wound Matrix is intended for use in the management of wounds. Wound types include: Partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, first and second degree burns, skin tears) and draining wounds.

Source page: https://510kreport.com/device/K161067
Methodology: https://510kreport.com/methodology