FDA Cleared Orthopedic Spine

FDA clears Orthofix Firebird SI fusion system

Orthofix (NSDQ:OFIX) announced today that it received FDA 501(k) clearance for its Firebird SI 3D-printed titanium bone screw.

Lewisville, Texas-based Orthofix touts its Firebird SI as the first 3D-printed titanium bone screw to launch in the U.S. for treating sacroiliac (SI) joint dysfunction. The fusion system is designed to both compress and stabilize the SI joint, according to a news release.

The Firebird SI includes a porous mid-shaft region designed to allow bone to grow into its surface, creating a bond between the implant and the patient’s bone at the SI joint. With a cannulated screw design, surgeons can pack the device with autografts and/or allografts with viable cells to help ensure bone fusion.

Screws for the system are available at a variety of lengths and diameters and are implanted through a minimally invasive surgery that takes about one hour and may lead to less time at the hospital with faster recovery, Orthofix said.

The company is launching the novel system in the U.S. through a limited market release, having already seen Dr. Justin Hall of the Baptist Memorial Hospital-Golden Triangle (Columbus, Miss.) complete the first U.S. implant.

“Orthofix Spine prides itself in creating differentiated technology for the advancement of patient care,” Orthofix Spine global president Kevin Kenny said in the news release. “We are excited to bring the Firebird SI fusion system to market as an extension of our flagship Firebird line of devices. This new system is another example of our commitment to providing surgeons and their patients with innovative options that interface with products and solutions within our portfolio.”

Original Article: (https://www.massdevice.com/fda-clears-orthofix-si-fusion-system/)

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