# K170300: Restrata Wound Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Acera Surgical, Inc.
- Decided: Apr 26, 2017 after 85 days
- Product code: QSZ (Absorbable Synthetic Wound Dressing)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K842066 (1985). 81 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 86 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132397: Gore Bio-a Wound Matrix, W. L. Gore & Associates, Inc. (2014) Summary page 5.
- K161278: Cerafix Dura Substitute, Acera Surgical, Inc. (2016) Summary page 5.

## Most influential descendants
- K193583: Restrata® (2020), 1 descendant of its own
- K254256: LUOFUCON® Wound Matrix (2026), 0 descendants of its own
- K260020: Redermo Wound Matrix (2026), 0 descendants of its own
- K223725: Restrata® MiniMatrix (2023), 0 descendants of its own

## Recalls of this device
- Mar 21, 2022 · Class II · Z-1030-2022: Misprinted expiration date on the shelf-box

## Indications for use
Restrata® Wound Matrix is intended for use in the management of wounds, including: Partial and full thickness wounds, pressure sores/ ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled / undermined wounds, surgical wound (e.g., donor site/ grafts, post-laser surgery, post-Mohs surgery, podiatric wounds, wound dehiscence), trauma wounds (e.g., abrasions, lacerations, partial thickness burns, skin tears), and draining wounds.

Source page: https://510kreport.com/device/K170300
Methodology: https://510kreport.com/methodology