CraniUS Therapeutics gains US clearance for cranial reconstruction implant
CraniUS Therapeutics has received FDA 510(k) clearance for the CraniUS Plate, a patient-specific cranioplasty implant designed to repair cranial defects.
The clearance allows the company to market the device in the US and represents its first commercially available product.
The FDA issued its substantial equivalence determination on 29 July 2026 under submission K261058.
The CraniUS Plate is classified as a Class II preformed alterable cranioplasty plate under 21 CFR 882.5320, with product code GWO.
The implant is manufactured to match each patient’s individual cranial anatomy.
It is intended for reconstruction of defects resulting from trauma, tumour removal, decompressive craniectomy and other causes.
The cleared device is designated NeuroPASS 1 and forms the initial configuration of CraniUS Therapeutics’ NeuroPASS platform.
The company is developing the platform as a configurable patient-specific implant architecture that may support future applications in brain access, diagnostics and targeted drug delivery.
These additional programmes are still under development and are not included in the current FDA clearance.
Planned areas include long-term brain access, integrated sensing and diagnostic capabilities, and targeted delivery of medicines within the cranial space.
The CraniUS Plate is currently cleared only for the repair of cranial defects and is the first product from the company to receive US marketing clearance.
