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.
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...
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.
You are out of free articles for this month
Subscribe as a Guest for $0 and unlock a total of 5 articles per month.
You are out of five articles for this month
Subscribe as an Executive Member for access to unlimited articles, THE ORTHOPAEDIC INDUSTRY ANNUAL REPORT and more.
JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.