IlluminOss Medical Receives FDA Clearance for Use in Femur, Tibia Fractures to Support Hardware

By Julie A. Vetalice

IlluminOss Medical Receives FDA Clearance for Use in Femur, Tibia Fractures to Support Hardware

IlluminOss Medical received an expanded FDA 510(k) clearance for its Photodynamic Bone Stabilization System, allowing use in femur and tibia fractures as a supplement to FDA-cleared fracture fixation systems. The indication expansion follows recent clearance for use in fibula fractures.

The IlluminOss System is a minimally invasive approach for fracture repair and stabilization through an intramedullary implant. It employs a light-curable liquid monomer, within an expandable balloon, to create a patient-conforming, rigid implant within the bone canal.

"Femur and tibia fractures can be challenging in aging patients where osteoporotic bone often lacks the strength required for reliable fixation with traditional hardware systems," said Robert Rabiner, Chief Technology Officer of IlluminOss. "This new clearance allows the surgical community to use the IlluminOss intramedullary implant as a supplement to these systems and help prevent construct failures by dramatically improving the holding power of screws and other hardware."

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory