FDA cleared the cranial plate CraniUS wants to build on

The FDA issued a substantial equivalence determination for the CraniUS Plate on 29 July 2026 under 510(k) number K261058. CraniUS Therapeutics, founded in Baltimore in 2021, announced the clearance on 9 September. The device is a patient-specific cranioplasty implant for repairing cranial defects left by trauma, tumour resection or decompressive craniectomy, and is classified as a Class II preformed alterable cranioplasty plate under product code GWO. It was reviewed by the Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices.

On its own, a custom-fitted skull plate is established surgery. What makes this a cybernetics story is what the company says it is for. CraniUS designates the cleared device NeuroPASS 1 and calls it the foundation of an investigational platform intended to add brain access, integrated diagnostics and drug delivery designed to bypass the blood-brain barrier.

That is the pattern worth naming: the piece that clears first is the inert structural one, and the electronics and pharmacology arrive later as additions to hardware already inside people. Nothing beyond the plate is cleared. The platform above it remains investigational.