Oxford Performance Materials (OPM) out of South Windsor, CT has announced that it has received FDA 510(k) clearance for its new OsteoFab 3D printed cranial device. This marks the first approval for an additively manufactured polymer implant. The new OPM device is a cranial maxillo-facial (CMF) plate for skull reconstruction which can be used to replace up to 75% of the skull. Their device is made from PEKK (polyetherketoneketone), which has many of the desirable properties of the commonly used PEEK implant material — but it also has twice the compressive strength, making it an ideal material to replace any bone that counts user protection among its primary functions.
via Oxford Performance Materials Now Able to 3D Print 75% New Skulls.