FDA cleared the CraniUS Plate under K261058, a patient-specific cranial implant indicated for the repair of cranial defects. The Baltimore company announced the clearance September 9.
Each plate is manufactured to the patient's anatomy for defects left by trauma, tumor resection or decompressive craniectomy. It is also the first piece of NeuroPASS, the platform CraniUS wants to build into the space under a cranial implant: durable brain access, implanted sensing, and drug delivery that bypasses the blood-brain barrier. None of those functions is cleared, and a drug delivery implant will not reach the market through a 510(k).
CraniUS spun out of Johns Hopkins and was founded in 2021. It closed a $20M Series B in February 2026 and holds an NIH award worth up to $4M for the direct-to-brain delivery work in recurrent glioblastoma.
Clearing the passive implant first buys a validated manufacturing process, a sales channel and surgeon familiarity before the hard submission arrives. That is a cheaper way in than starting with the combination product.