IlluminOss Medical today said it received expanded FDA 510(k) clearance for its Photodynamic bone stabilization system to treat fibula fractures.
The IlluminOss system was previously cleared by the FDA to treat traumatic, fragility, pathological and impending pathological fractures of the humerus, radius, ulna, clavicle, pelvis, metacarpals, metatarsals and phalanges. It is also designed to be used with other FDA-cleared fracture fixation systems to provide supplemental fixation in anatomic sites.
“The IlluminOss technology offers a minimally invasive approach that spares soft tissues, which may lower the risk of wound complications, and can potentially drive better functional outcomes, including a faster return to weight-bearing and activities of daily living,” chief technology officer Robert Rabiner said in a news release. “Fractures of the fibula, one of the long bones of the lower leg, are among the most common and can be particularly challenging to manage in elderly patients. Additionally, current treatment approaches such as plating have several disadvantages, including larger incisions and the potential for meaningful patient discomfort.”
The system uses a light-curable liquid monomer that is contained within an expandable balloon to create a patient-conforming, rigid implant within the bone canal for fracture repair and stabilization through a patient-specific intramedullary implant.
“Quickly returning elderly fracture patients to the activities of daily living remains a significant challenge or opportunity in orthopedics,” chairperson Mike Mogul said. “The fibula clearance, in addition to the recently approved pelvic and clavicle indications, is yet another step toward IlluminOss’ goal of providing minimally invasive fracture care in the majority of fractures faced by those elderly patients.”