Orthofix Announces FDA 510(k) Clearance for the Rodeo Telescopic Nail

LEWISVILLE, Texas — May 9, 2024 — Orthofix Medical Inc. (NASDAQ:OFIX), a leading global spine and orthopedics company, today 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.

“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, 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.”

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.

Orthofix will be exhibiting at the EPOSNA Annual Meeting (Booth #24) May 8-11 in National Harbor, Maryland, and featuring the Rodeo Telescopic Nail in an educational symposium entitled “Osteogenesis Imperfecta Disease: Shared Experiences on Different Techniques and the Latest Solutions.”

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.

For more information about Orthofix’s full portfolio of pediatric solutions, please visit OrthofixKids.com.

You can read the full news release here.