# K242149: NovoSorb® MTX

- Pathway: 510(k) (Traditional)
- Applicant: Polynovo Biomaterials Pty, Ltd.
- Decided: Mar 5, 2025 after 225 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 K221686 (2022). 1 ancestor in all.
1 later device descends 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)
- K221686: NovoSorb Matrix, Polynovo Biomaterials Pty, Ltd. (2022) Summary page 5.

## Most influential descendants
- K251567: NovoSorb BTM (2025), 0 descendants of its own

## Indications for use
NovoSorb® MTX is indicated for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic and vascular ulcers, tunneled/ undermined wounds, 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 single use only.

Source page: https://510kreport.com/device/K242149
Methodology: https://510kreport.com/methodology