OSSIO Gains FDA Clearance for OSSIOfiber Bone Pin

By Julie A. Vetalice

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, where hardware removal is common, 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.

At the time of surgery, the mechanical strength of the implant is higher than cortical bone; it gradually transfers load to the native bone following the rehabilitation phase. Preclinical studies indicated that full integration into surrounding anatomy occurs within 18-24 months, leaving only native bone.

A multi-center European clinical trial is underway to evaluate the OSSIOfiber Hammertoe Fixation Implant, to support CE Mark application in 2020.

Source: OSSIO Ltd

Product Labels: Trauma Ankle/Foot/Toe

Tags: 510(k) Clearance, Regulatory