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FDA Will Allow Marketing of IlluminOss Bone Stabilization System

January 11, 2018

On January 9, 2018, IlluminOss Medical announced that it had received permission from the Food and Drug Administration (FDA) to market the IlluminOss Photodynamic Bone Stabilization System for the treatment of impending and actual pathological fractures of the humerus, radius and ulna from metastatic bone disease, in skeletally mature patients. The FDA granted permission to market the device in late December 2017, via the agency’s de novo classification pathway.

The IlluminOss Photodynamic Bone Stabilization System is a novel implanted device consisting of a balloon that is inserted into the medullary canal of long bones for the fixation of fractures. The balloon is infused with, and completely encapsulates, a liquid monomer that is exposed to a curing agent which polymerizes the monomer within the balloon creating a hardened rigid structure, according to the de novo classification order. The device was granted CE marking in 2009.

 

Food and Drug Administration (FDA). Classification order [DEN160062]. December 19, 2017. Available at: click here. Accessed January 10, 2018.