CraniUS Therapeutics Secures US FDA Clearance for CraniUS Plate

CraniUS Therapeutics has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for the CraniUS Plate, a customised implant developed to reconstruct cranial defects. 

The clearance enables the company to commercialise the device in the US and represents its first product to reach the market.

The FDA completed its substantial equivalence review on 29 July 2026 under submission K261058. 

The device is classified as a Class II preformed alterable cranioplasty plate under 21 CFR 882.5320 and product code GWO.

The CraniUS Plate is produced according to each patient’s cranial anatomy, providing surgeons with an implant designed specifically for individual reconstruction requirements. 
The device is intended for cranial defect repair following trauma, tumour removal, decompressive craniectomy and other procedures or conditions.

CraniUS has designated the cleared plate as NeuroPASS 1, establishing the initial version of its NeuroPASS cranial implant platform. 

The company is also researching potential future configurations that could support brain access, sensing and diagnostic capabilities, as well as targeted delivery of medicines within the cranial space.

These applications are still investigational and are not covered by the current FDA clearance.

At present, the CraniUS Plate is authorised only for cranial defect repair. Further applications will require separate development and appropriate regulatory authorisation.