OSSIO Inc.’s OSSIOfiber Compression Screw Portfolio has received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) for maintenance of 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.
 
This is the third FDA clearance for the company’s OSSIOfiber Intelligent Bone Regeneration Technology, which uses proprietary bio-integrative material to provide stability and secure bone fixation while leaving no permanent hardware behind. To date, more than 1,000 OSSIOfiber implantations have been successfully conducted in the United States.
 
OSSIO’s Compression Screw Portfolio will initially comprise a 4.0mm-diameter cannulated, headless, partially threaded compression screw in lengths ranging from 26mm to 60mm. The bio-integrative combines the necessary strength for bone fixation with the ability to fully integrate into the surrounding anatomy without adverse foreign body reactions and stress shielding, and avoids potential patient discomfort or implant related complications that are often associated with permanent metal hardware. Studies show that implants made from OSSIOfiber provide easy insertion and secure fixation with rapid bone attachment in as little as two weeks following surgery, and gradual, safe incorporation and complete integration into the surrounding anatomy within 18 to 24 months.
 
“I’ve utilized OSSIOfiber implants in numerous foot and ankle procedures, from the complex to the routine, and I’ve been continually impressed by their ability to provide strong and stable fixation, natural healing and complete bio-integration, resulting in a quick return to improved function and quality of life for my patients,” said Tom San Giovanni, MD, director of foot & ankle surgery, Department of Orthopedic Innovation at Miami Orthopedics & Sports Medicine Institute. “With compression screws being one of the most widely used fixation tools used today, OSSIO’s latest contribution to the fixation market shows real promise in successfully addressing multiple lower and upper extremity injuries. I look forward to adding this portfolio of innovative headless compression screws to my surgical repertoire.”
 
OSSIO will commercially launch the OSSIOfiber Compression Screws in the United States in early 2021 and plans to expand its portfolio in varying diameters (3.5-6.5mm), lengths and geometry to address many trauma and extremity procedures.