# K031684: Topkin Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Merck GmbH
- Decided: Oct 30, 2003 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: 1 generation back to K982939 (1998). 1 ancestor in all.
19 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982939: BTF Thin Film Wound Dressing, Bioderm, Inc. (1998) Summary page 5.

## Most influential descendants
- K090160: Suprathel Wound and Burn Dressing (2009), 18 descendants of its own
- 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

## Indications for use
For temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions.

Source page: https://510kreport.com/device/K031684
Methodology: https://510kreport.com/methodology