# K223445: ArtiFascia

- Pathway: 510(k) (Traditional)
- Applicant: Nurami Medical, Ltd.
- Decided: Aug 10, 2023 after 269 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: 4 generations back to K950956 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161278: Cerafix Dura Substitute, Acera Surgical, Inc. (2016) Summary page 4.

## Indications for use
ArtiFascia is indicated as dura substitute for the repair of dura mater. ArtiFascia is indicated for defects of 25cm2 (3.87 in2) or less in area. For example, 6 cm X 4 cm (24 cm2) would be an acceptable defect size.

Source page: https://510kreport.com/device/K223445
Methodology: https://510kreport.com/methodology