IlluminOss Medical received expanded FDA 510(k) clearance for its Photodynamic Bone Stabilization System for treatment of fractures of the pelvis, clavicle and small bones of the hands and feet: metacarpals, metatarsals and phalanges. This builds upon previous clearance for the treatment of traumatic, fragility, pathological and impending pathological fractures of the humerus, radius and ulna.
The IlluminOss System offers fracture repair and stabilization through a patient-specific intramedullary implant. The system uses a light-curable liquid polymer, contained within an expandable balloon, to create a patient-conforming, rigid implant within the bone canal.
"The new indication expansion significantly broadens the opportunities to address the geriatric fragility fracture market where patients often have poor bone quality," said Robert Rabiner, Chief Technology Officer. "An example would be fractures of the pelvis; IlluminOss is deployed through a small, minimally invasive, tissue-sparing incision. Our system conforms to the curvature of the pelvis, and in a simple procedure provides strength and stability to the fracture. Surgeons report their patients have a rapid return to function, which is crucial for this patient population, as well as significant reduction in the use of post-operative opioids."
The IlluminOss technology has been in clinical use in Europe since 2010, with over 4,000 procedures to date. In the US, the IlluminOss System was previously cleared by the FDA for the treatment of traumatic, fragility, pathological, and impending pathological fractures of the humerus, radius, and ulna. IlluminOss can be also used in conjunction with FDA-cleared fracture fixation systems to provide supplemental fixation in compromised bone in all cleared anatomic sites.