US-based spine and orthopaedics company Orthofix Medical has received the US Food and Drug Administration (FDA) 510(k) approval to market its Rodeo Telescopic Nail.
The Rodeo system is an advanced orthopaedic device indicated for surgical treatment of deformities or fractures in patients suffering from osteogenesis imperfecta (OI).
It is designed to stabilise the patient’s limb while also elongating or telescoping to facilitate natural growth in paediatric patients.
Orthofix said that the implant system addresses several biomechanical and procedural challenges linked to current OI telescopic rod systems.
Its patented design provides the strength and reliable bone fixation required when implanting in the inherently fragile bone associated with OI patients, said the medical device company.
Global Orthopedics president Kim Elting said: “The launch of the Rodeo Telescopic Nail represents Orthofix’s continued commitment to address the underserved paediatric market with specialised solutions tailored to the specific needs and unique conditions, such as OI, of this patient population.
“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.”
The Rodeo system comes with a streamlined implant procedure and its instrumentation and sterile pack configurations support the optimising efficiency in the operating room (OR).
The system also eliminates the need to sterilise trays leading up to the surgery, which will reduce procedural costs, OR time, and risks of contamination.
Often called brittle bone disease, OI affects both males and females worldwide with a prevalence estimated to be one in 10,000 births.
In children born with OI, the bones are formed abnormally, may break easily, and involve hundreds of fractures without apparent cause, in more severe cases.
Earlier this year, Orthofix signed a commercial distribution agreement with Dutch medical imaging firm MRIguidance for its BoneMRI imaging software in the US.
The BoneMRI software converts an MRI exam into a synthetic CT without radiation.
