# K073251: Hyalomatrix PA

- Pathway: 510(k) (Traditional)
- Applicant: Fidia Advanced Biopolymers Srl
- Decided: Dec 14, 2007 after 25 days
- Product code: QSZ (Absorbable Synthetic Wound Dressing)
- Device class: U
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K881854 (1988). 14 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001508: Laserskin Dressing, Fidia Advanced Biopolymers Srl (2001) Summary page 1.
- K021792: Bilayer Matrix Wound Dressing, Integra Lifesciences Corp. (2002) Summary page 1.
- K061711: Oasis Wound Matrix, Cook Biotech, Inc. (2006) Summary page 1.

## Most influential descendants
- K261311: Hyalomatrix (2026), 0 descendants of its own
- K092257: Jaloskin (2010), 0 descendants of its own

## Recalls of this device
- May 10, 2018 · Class II · Z-2423-2018: Hyalomatrix products are susceptible to degradation as a result of the decomposition of PVC in the packaging material during sterilization, which resulted in degradation of the film. Over the long ter

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

Source page: https://510kreport.com/device/K073251
Methodology: https://510kreport.com/methodology