No Bones About It: Orthofix Gets FDA Clearance for 3D-Printed Bone Screw featuring Nanotechnology

The Lewisville-based company's new fusion system is designed to compress and stabilize the sacroiliac joint. Its high-tech features make it the first of its kind specifically designed for SI joint solutions.

Other recent news includes a $10 million partnership with a Swiss medtech firm and a new division president.

Illustration of the Orthofix FIREBIRD SI Fusion System with NANOVATE technology [PHOTO: Business Wire]

Of all the joints in all the world, you don’t want trouble with your sacroiliac. Its two joints connect your hip bones to your sacrum, connecting your spine to your hips. Studies have shown that “SI joint” pain affects between 15 and 30 percent of people with chronic lower back pain.

Thanks to Lewisville-based Orthofix Medical Inc., high-tech help is on the way. Orthofix recently received FDA approval for the first 3D-printed titanium bone screw with nanotechnology specifically designed to compress and stabilize the SI joint during fusion.

Kevin Kenny, global president of Orthofix Spine, says its FIREBIRD SI Fusion System is the result of his company’s intense focus on bringing innovations to the market, enabling surgeons to meet their patients’ needs. “The clearance of the nanotechnology feature gives us the opportunity to educate surgeons about the unique benefits of the system’s nano-surface,” Kenny said in a release.

The FIREBIRD system is only the latest breakthrough from Orthofix. Founded in Verona, Italy, in 1980, the company is celebrating its 40th year in orthopedic innovation. The global medical device company focuses on musculoskeletal products and therapies, with more than 1,000 employees worldwide. Its spine and orthopedic extremities products are distributed in more than 70 countries, the company says.

In September, Orthofix announced a partnership and investment agreement with Neo Medical SA, a privately held Swiss-based Medtech company developing a new generation of products for spinal surgery. Orthofix is investing $10 million in Neo Medical to support the ongoing partnership, Orthofix said in a release.

In another move last month, the company named Paul Gonsalves as president of its Orthofix Global Extremities business. Gonsalves had previously been chief commercial officer of Integra LifeSciences.

Orthofix has collaborated on research and development with leading clinical organizations such as MTF Biologics, the Orthopedic Research and Education Foundation, and Dallas’ Texas Scottish Rite Hospital for Children.

Now let’s get back to your back.

Common causes that may lead to SI joint dysfunction and pain include trauma, lifting or twisting, pregnancy, natural childbirth, and degeneration from previous lumbar spine surgery, the company said in the release. Other causes include stresses to the joint due to leg length differences, joint replacement, and scoliosis.

Featuring a cannulated screw design, Orthofix’s new system enables surgeons to pack the device with autograft and/or allografts to help promote bone fusion. FIREBIRD SI screws are available in an assortment of lengths and diameters to address a variety of patient anatomies. Orthofix offers allograft solutions such as the Trinity ELITE allograft with viable cells through its partnership with MTF Biologics.

Innovative? Definitely. But here’s hoping you won’t need it!


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