FDA cleared CraniUS Therapeutics' NeuroPASS 2 cranioplasty plate on September 11, 2026 under K262874. NeuroPASS 1 cleared on July 29 under K261058. The company disclosed both on October 7 alongside a patent, and said the second clearance landed ahead of its own fourth-quarter target.
Both plates are patient-specific PEEK devices, Class II under 21 CFR 882.5320, product code GWO, reviewed by CDRH's neurosurgical, neurointerventional and neurodiagnostic devices division. The indication covers filling bony voids or defects in the cranial skeleton, prescription use, adults 22 and older. NeuroPASS 2 adds a surgeon-requested pattern of holes sized for an implantable intracranial pressure sensor and is labeled MR Safe. The sensor and reservoir are not part of the cleared device.
The USPTO issued patent 12,752,051 on October 7 for a cranial drug delivery system: a temporal implant with a refillable reservoir, a regulated-flow pump and catheters running to a brain target. That product is NeuroPASS 3, a drug-led combination product still in nonclinical work, with a first-in-human study targeted for the second quarter of 2027.
Clearing the housing before the electronics is the cheaper sequence. The plate rides a long-standing predicate and product code, and holes for a future sensor read as a geometry and labeling change rather than a new review question. The combination product is where the timeline risk actually sits.