OSSIO Launches Bio-Integrative OSSIOfiber Compression Screws

OSSIO Inc. proclaimed the U.S. launch and first commercial use of the OSSIOfiber Compression Screws to maintain alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts of the upper extremity, fibula, knee, ankle, and foot in the presence of appropriate brace and/or immobilization. The first commercial cases using the novel screw system were successfully conducted by surgeons who performed Medial Malleolar Fracture and Lapidus procedures, and  a 1st MTP/MPJ Fusion procedure.
 
The OSSIOfiber Compression Screw portfolio earned a 510(k) from the U.S. Food and Drug Administration (FDA) in 2020 and the initial product offering is applicable to treat multiple lower and upper extremity injuries. According to the company, the bio-integrative implant is the only compression screw on the market that combines the necessary strength for secure bone fixation with the ability to fully integrate into the surrounding anatomy without adverse foreign body reactions or stress shielding, while avoiding implant related complications and secondary hardware removal surgeries.
 
Comprised of proprietary OSSIOfiber Intelligent Bone Regeneration Technology, these compression screws are engineered to achieve the optimal balance of flexural, torque, axial, and shear strength. Additionally, their design ensures a seamless fit into existing surgical techniques, and the sterile, disposable instrumentation system helps streamline operating room preparation and reduces unnecessary pathogen exposure.
 
“Compression screws are an important tool in the bone fixation arsenal and OSSIO has fulfilled a real need in the space by developing a breakthrough implant that gradually integrates into the bone, ultimately leading to a complete return to full strength and a total natural healing – something that other implants have not been able to provide,” Samuel Adams, M.D., Associate Professor of Orthopaedic Surgery at Duke University Health System, Durham, N.C., who recently performed a successful Medial Malleolar Fracture procedure using the unique implants, told the press. “The screw portfolio’s pre-clinical performance data is strong and its instrumentation system is straightforward. I look forward to regularly utilizing this fixation solution in my clinical practice.”
 
Additional procedures utilizing the OSSIOfiber Compression Screws are planned in limited markets in the coming weeks, with full commercialization in April. The initial portfolio is comprised of 4mm-diameter cannulated, headless, partially threaded compression screws in lengths ranging from 26-60mm, enabling surgeons to choose the size and orientation that best fits the patient’s individual anatomy. OSSIO plans to expand its compression screw portfolio in varying diameters, lengths, and geometry to address additional extremity procedures as well as trauma cases in the near future.