# K221686: NovoSorb Matrix

- Pathway: 510(k) (Special)
- Applicant: Polynovo Biomaterials Pty, Ltd.
- Decided: Sep 15, 2022 after 97 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K242149: NovoSorb® MTX (2025), 1 descendant of its own
- K251567: NovoSorb BTM (2025), 0 descendants of its own

## Indications for use
NovoSorb® Matrix 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, partial thickness burns, and skin tears) and draining wounds.

Source page: https://510kreport.com/device/K221686
Methodology: https://510kreport.com/methodology