Orthopaedic fixation company Ossio has received US Food and Drug Administration (FDA) 510(k) market clearance for OSSIOfiber Hammertoe Fixation System to maintain alignment and fixation of bone fractures, arthrodesis, osteotomies and bone grafts.
Designed in three sizes, the bio-integrative implants with disposable, sterile instrumentation are available with straight and angled configurations.
It will enable the customisation of the system among various patient anatomies.
The fixation system, made from a proprietary natural mineral fibre matrix, utilises the company’s OSSIOfiber Intelligent Bone Regeneration Technology. It combines mechanical strength and natural bone healing in a non-permanent implant.
Its bio-integrative material properties enable the surgeons to adapt to a more biologically friendly way to restore the stability and mobility of the patients.
Ossio CEO Brian Verrier said: “With more than 500 successful hammertoe repairs conducted to date utilising the OSSIOfiber Hammertoe Implant, along with the completion of our European multi-centre study confirming the overall safety and positive performance of our proprietary technology, confidence in achieving excellent clinical outcomes and high surgeon and patient satisfaction continues to grow.”
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In Europe, a multi-centre clinical trial was conducted by Ossio last year to assess the safety and performance of the OSSIOfiber Hammertoe Fixation System.
The positive findings from the trial should support the CE Mark approval of the system later this year.
Ossio is planning the launch of hammertoe fixation system along with several other OSSIOfiber products over the next year.
In January last year, FDA cleared the OSSIOfiber Bone Pin Family, later commercialised as part of a limited market release for the treatment of common forefoot conditions, such as hammertoe, in the foot and ankle segment.