Orthofix Medical received FDA 510(k) clearance to market its Rodeo Telescopic Nail.
Rodeo is 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 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.
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.
Kim Elting, President of Global Orthopedics, said, “The Rodeo system has been very well received in Europe, and we are pleased to be able to announce this limited U.S. market release during National OI Awareness Week and join in educating others about this genetic bone disorder that is present at birth.”
Orthofix Medical received FDA 510(k) clearance to market its Rodeo Telescopic Nail.
Rodeo is 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 telescoping to accommodate the natural growth of pediatric patients. ...
Orthofix Medical received FDA 510(k) clearance to market its Rodeo Telescopic Nail.
Rodeo is 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 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.
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.
Kim Elting, President of Global Orthopedics, said, “The Rodeo system has been very well received in Europe, and we are pleased to be able to announce this limited U.S. market release during National OI Awareness Week and join in educating others about this genetic bone disorder that is present at birth.”
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