Orthofix Medical Inc. announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market its Rodeo Telescopic Nail. The Rodeo Telescopic Nail is an innovative device indicated to surgically treat deformities or fractures in patients suffering from osteogenesis imperfecta (OI). The nail implant serves to stabilize the patient?s limb while also elongating (or telescoping) to accommodate the natural growth of pediatric patients.

The Rodeo system is designed to address many of the biomechanical and procedural challenges associated with current OI telescopic rod systems. Specifically, its patented design provides the strength and reliable bone fixation required when implanting in the inherently fragile bone associated with OI patients. The implant procedure is streamlined and the system?s instrumentation and sterile pack configurations aid in optimizing efficiency in the operating room and eliminate the need to sterilize trays leading up to the surgery, thereby reducing procedural costs, O.R. time, and risks of contamination. Often referred to as brittle bone disease, OI affects both males and females equally throughout the world with a prevalence estimated to be one in 10,000 births.

A child born with OI may have bones that break easily or form abnormally. In more severe cases, it can involve hundreds of fractures that occur without apparent cause. The Rodeo Telescopic Nail will be available soon at select institutions in the U.S.; it has been in clinical use in a limited number of European countries since 2022 with more than 170 surgeries performed to date.