# K170213: SupraSDRM Biodegradable Matrix Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Polymedics Innovations, GmbH
- Decided: Jun 28, 2017 after 155 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: 6 generations back to K973688 (1997). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090160: Suprathel Wound and Burn Dressing, Polymedics Innovations, GmbH (2009) Summary page 7.

## Indications for use
The SupraSDRM Biodegradable Matrix Wound Dressing is indicated for use in the management of: • Partial and full thickness wounds • Pressure (stage I and IV) and venous ulcers • Ulcers caused by mixed vascular etiologies • Venous stasis and diabetic ulcers • 1st and 2nd degree burns • Partial thickness burns • Cuts and abrasions • Acute wounds • Trauma wounds • Surgical wounds • Superficial wounds • Grafted wounds and donor sites

Source page: https://510kreport.com/device/K170213
Methodology: https://510kreport.com/methodology