# K090160: Suprathel Wound and Burn Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Polymedics Innovations, GmbH
- Decided: May 20, 2009 after 118 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: 5 generations back to K973688 (1997). 28 ancestors in all.
18 later devices descend from it; 4 cite it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012995: Collatek Sheet, Biocore Medical Technologies, Inc. (2001) Summary page 7.
- K031684: Topkin Wound Dressing, Biomet Merck GmbH (2003) Summary page 7.
- K031712: Inion Otps Biodegradable Pin, Inion, Ltd. (2003) Summary page 7.
- K031955: Macropore Surgi-Wrap Mast Bioresorbable Sheet, Macropore Biosurgery, Inc. (2003) Summary page 7.
- K061227: Hydrolyzed Collagen/AG Wound Gel with Silver, The Hymed Group Corp. (2006) Summary page 7.
- K062558: Mesosfol Surgical Film, Biomet Manufacturing Corp (2007) Summary page 7.
- K982939: BTF Thin Film Wound Dressing, Bioderm, Inc. (1998) Summary page 7.
- K990086: Heliderm Collagen Wound Dressings 0.5 Gram and 1.0 Gram, Integra Lifesciences Corp. (1999) Summary page 7.

## Most influential descendants
- K132397: Gore Bio-a Wound Matrix (2014), 10 descendants of its own
- K142879: BTM Wound Dressing (2015), 5 descendants of its own
- K172140: NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) (2017), 4 descendants of its own
- K170300: Restrata Wound Matrix (2017), 4 descendants of its own
- K161067: Mirragen Advanced Wound Matrix, 4x4”, Mirragen Advanced Wound Matrix, 2x2”, Mirragen Advanced Wound Matrix, 1x6” (2016), 3 descendants of its own

## Indications for use
The 'Suprathel Wound and Burn Dressing is indicated for temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions. The dressing is intended to maintain a moist wound healing environment. A moist wound healing environment allows autolytic debridement. The Suprathel Wound and Burn Dressing is used 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/K090160
Methodology: https://510kreport.com/methodology