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Reimbursement / Regulatory

OSSIO Gains FDA Clearance for OSSIOfiber Bone Pin -

OSSIO received FDA 510(k) clearance to market OSSIOfiber™ bone pins, made of a proprietary bio-integrative material designed to provide stability and secure bone fixation that will leave no hardware behind. Product launch is slated for 2Q19. First commercial use will occur in the treatment of forefoot conditions, though the platform will have broad application across orthopaedics, including distal extremities, trauma, sports medicine, reconstruction, pediatrics and spine in the form of pins, screws and plates. A multi-center European clinical trial is underway to evaluate the OSSIOfiber Hammertoe Fixation Implant, to support CE Mark application in 2020. (OSSIO Ltd., 1/14/19)