Orthofix Wins FDA Nod for Rodeo Telescopic Nail

Orthofix has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its Rodeo telescopic nail.
 
The Rodeo device surgically treats deformities or fractures in patients with osteogenesis imperfecta (OI), also known as brittle bone disease. A child born with OI may have bones that break easily or form abnormally. The Rodeo nail implant stabilizes the patient’s limb while elongating (telescoping) to accommodate pediatric patients’ natural growth.
 
The company said Rodeo addresses many biomechanical and procedural challenges related to current OI telescopic rod systems. Its design has the strength and reliable bone fixation needed where implanting in the fragile bone of OI patients, Orthofix said. The system’s instrumentation and sterile pack configurations also help operating room efficiency and remove the need for sterilization in the days leading to surgery.
 
“The launch of the Rodeo Telescopic Nail represents Orthofix’s continued commitment to address the underserved pediatric market with specialized solutions tailored to the specific needs and unique conditions, such as OI, of this patient population,” said Kim Elting, Orthofix’s president of Global Orthopedics. “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 said the Rodeo telescopic nail will soon be available at select U.S. institutions. It’s been used in a limited number of European countries since 2022 with over 170 surgeries performed to date.
 
Earlier this week, Orthofix posted its Q1 financial results. The company generated net sales of $188.6 million in the first quarter, an increase of 7.7% on a reported basis and narrowed its full-year 2024 revenue guidance.