IlluminOss Medical Gains FDA Clearance to Expand Trauma Indications

By Julie A. Vetalice

IlluminOss Medical received FDA 510(k) clearance for the IlluminOss Photodynamic Bone Stabilization System to treat skeletally mature patients with traumatic, fragility, impending and pathological fractures of the humerus, radius and ulna.

The IlluminOss System gained FDA de novo clearance for metastatic bone fractures in January—Agency’s first de novo clearance under the orthopaedic panel. Its first procedure and CE Mark approval occurred in 2009, and the system has been commercially available ex-U.S. since 2010.

The procedure uses a light-curable liquid monomer, contained within an expandable PET balloon catheter, to achieve stabilization. It is performed through a small percutaneous incision. Once the implant is cured and polymerized, it conforms to the geometry of a patient’s intramedullary canal.

Sources: IlluminOss Medical; ORTHOWORLD, Inc.

Product Labels: Upper Extremity

Tags: 510(k) Clearance, Regulatory