FDA grants 510(k) clearance to Ossio’s compression screw portfolio

20 October 2020 (Last Updated October 20th, 2020 11:41)

The Food and Drug Administration (FDA) has granted 510(k) market clearance to orthopaedic fixation technology company Ossio’s OSSIOfiber compression screw portfolio.

FDA grants 510(k) clearance to Ossio’s compression screw portfolio
Ossio’s impalnts are designed to fully integrate into the surrounding anatomy within 18 to 24 months. Credit: Dr. Manuel González Reyes / Pixabay.

The Food and Drug Administration (FDA) has granted 510(k) market clearance to orthopaedic fixation technology company Ossio’s OSSIOfiber compression screw portfolio.

The portfolio has been cleared 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 suitable brace or immobilisation.

Initially, OSSIO’s compression screw portfolio will include a 4mm-diameter cannulated, headless, partially threaded compression screw in lengths from 26mm to 60mm.

The bio-integrative implant is the only compression screw on the market that can fully integrate into the surrounding anatomy without adverse foreign body reactions and provide strength for bone fixation at the same time.

It also eliminates patient discomfort or implant-related complications that are often associated with permanent metal hardware.

It is the third FDA clearance for the company’s OSSIOfiber Intelligent Bone Regeneration Technology.

OSSIOfiber Intelligent Bone Regeneration Technology uses the company’s flagship bio-integrative material to offer stability and secure bone fixation while leaving no permanent hardware behind.

Ossio CEO Brian Verrier said: “We are incredibly proud of the innovation we’ve brought to the orthopaedic fixation market with our OSSIOfiber technology. As demonstrated in clinical studies, and as we currently see in real-time clinical practice, our proprietary strong and bio-integrative platform continues to successfully deliver.

“The achievement of our 1,000th implant milestone, along with the recent FDA clearance for our compression screw portfolio, further showcases our commitment to changing a 100-year-old standard-of-care in orthopaedic fixation, transforming the patient experience and improving the overall healthcare economics of orthopaedics.”

OSSIOfiber Compression Screws will be available in the US, starting next year. Ossio plans to expand its portfolio in varying diameters, lengths and geometry to address many trauma and extremity procedures.

Currently, the company uses OSSIOfiber Intelligent Bone Regeneration Technology for surgical applications through the manufacturing of various implant designs such as nails, screws, staples, anchors, and plates.

The company plans to leverage the technology to pursue multiple applications in the distal extremity, trauma, sports, reconstruction, paediatrics, and spine markets in the future.

In March, Ossio secured FDA 510(k) clearance for OSSIOfiber Hammertoe Fixation System to maintain alignment and fixation of bone fractures, arthrodesis, osteotomies, and bone grafts.