# K261311: Hyalomatrix

- Pathway: 510(k) (Traditional)
- Applicant: Anika Therapeutics, Inc.
- Decided: Sep 2, 2026 after 134 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: 5 generations back to K881854 (1988). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073251: Hyalomatrix PA, Fidia Advanced Biopolymers Srl (2007) Summary page 5.

## Indications for use
HYALOMATRIX is indicated for the management of wounds including: •Partial and full-thickness wounds •Partial thickness second-degree burns •Pressure ulcers •Venous ulcers •Diabetic ulcers •Chronic vascular ulcers •Tunneled/undetermined wounds •Surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence) •Trauma wounds (abrasions, lacerations, skin tears) •Draining wounds

Source page: https://510kreport.com/device/K261311
Methodology: https://510kreport.com/methodology