Finally. The 1st and only “De Novo” clearance in orthopedics is granted to IlluminOss

IlluminOss Medical Granted FDA Marketing Clearance for the IlluminOss® Bone Stabilization System (press release)
IlluminOss Medical, a privately held, commercial-stage medical device company focused on minimally invasive orthopedic fracture repair, today announced that it has received U.S. Food and Drug Administration (FDA) de novo clearance for the IlluminOss Bone Stabilization System for treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease.
The IlluminOss System incorporates the use of a thin-walled PET balloon that is infuse...