# K250420: Helios Dura Regeneration Matrix

- Pathway: 510(k) (Traditional)
- Applicant: Helios Biomedical, Inc.
- Decided: May 14, 2025 after 90 days
- Product code: GXQ (Dura Substitute)
- Device class: 2
- Regulation: 21 CFR 882.5910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K950956 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161370: Durepair Dura Regeneration Matrix, Medtronic Neurosurgery (2016) Summary page 5.

## Indications for use
Helios Dura Regeneration Matrix is indicated as a dura substitute for the repair of the dura mater.

Source page: https://510kreport.com/device/K250420
Methodology: https://510kreport.com/methodology