# K142879: BTM Wound Dressing

- Pathway: 510(k) (Traditional)
- Applicant: Polynovo Biomaterials Pty, Ltd.
- Decided: Dec 23, 2015 after 447 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). 41 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K090160: Suprathel Wound and Burn Dressing, Polymedics Innovations, GmbH (2009) Summary page 5.
- K021792: Bilayer Matrix Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 5.

## Most influential descendants
- 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
- K231937: Foundation Dermal Regeneration Scaffold (DRS) Solo (2023), 2 descendants of its own
- K240298: Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo (2024), 1 descendant of its own
- K251567: NovoSorb BTM (2025), 0 descendants of its own
- K243181: Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo (2024), 0 descendants of its own

## Indications for use
The BTM Wound Dressing is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) and draining wounds. The device is intended for one-time use.

Source page: https://510kreport.com/device/K142879
Methodology: https://510kreport.com/methodology