FDA Clears OssDsign Cranial Implant

FDA has cleared an OssDsign 510(k) for the OssDsign Cranial PSI, a patient-specific medical implant intended for reconstruction of cranial defects (cranioplasty). Such procedures have traditionally been performed by neurosurgeons using a patient’s own bone or by using implants made from inert plastic or metal materials, such as PEEK or titanium. These techniques are known to have a high complication rate, according to the company, especially infections which may necessitate removal of the implant and further surgery.

Each OssDsign cranial implant is made to a patient’s unique requirements based on computer tomography information, the company says. It uses advanced computer-assisted design and state-of-the-art 3D-printing technologies to produce each unique device, which is made from a proprietary calcium phosphate composite that is reinforced by a titanium skeleton.