# K262874: CraniUS Plate

- Pathway: 510(k) (Special)
- Applicant: CraniUS, LLC
- Decided: Sep 11, 2026 after 28 days
- Product code: GWO (Plate, Cranioplasty, Preformed, Alterable)
- Device class: 2
- Regulation: 21 CFR 882.5320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K904111 (1990). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K261058: CraniUS Plate, CraniUS, LLC (2026) Summary page 5.

## Indications for use
The CraniUS Plate is indicated for use to fill a bony void or defect areas in a cranial skeleton.

Source page: https://510kreport.com/device/K262874
Methodology: https://510kreport.com/methodology