# K251567: NovoSorb BTM

- Pathway: 510(k) (Special)
- Applicant: Polynovo Biomaterials Pty, Ltd.
- Decided: Jun 20, 2025 after 29 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: 8 generations back to K973688 (1997). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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), Polynovo Biomaterials Pty, Ltd. (2017) Summary page 5.
- K242149: NovoSorb® MTX, Polynovo Biomaterials Pty, Ltd. (2025) Summary page 5.

## Indications for use
NovoSorb BTM is indicated for use in 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.

Source page: https://510kreport.com/device/K251567
Methodology: https://510kreport.com/methodology