# K222189: SiOxD Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Sioxmed, LLC
- Decided: Nov 18, 2022 after 119 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: 10 generations back to K953781 (1995). 124 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161067: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6”, Engineered Tissue Solutions, LLC (2016) Summary page 4.
- K142363: Nustat, Nustat XR, Beeken Biomedical (2015) Summary page 4.

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

## Indications for use
The SiOxD 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 degree and partial thickness burns, skin tears) and draining wounds.

Source page: https://510kreport.com/device/K222189
Methodology: https://510kreport.com/methodology