FDA clears Hammertoe Fixation System
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OSSIO Inc. has received 510(k) market clearance from the FDA for its OSSIOfiber Hammertoe Fixation System.
The company received initial clearance in January 2019 in a limited market release for use on forefoot conditions, with its newest system now fully cleared for “maintenance of alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts,” according to a company press release.
With three different sizes and bio-integrative implants that allow for both straight and angled designs to match patient anatomy, OSSIO notes the system provides a more biologically friendly way to treat patients.
CEO of OSSIO Brian Verrier said the natural mineral fiber matrix of the system will help “avoid the risks, costs and trade-offs associated with permanent implants.”
“With more than 500 successful hammertoe repairs conducted to date utilizing the OSSIOfiber hammertoe implant, along with the completion of our European multicenter 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,” Verrier said in the release.
Reference:
https://ossio.io/wp-content/uploads/2020/03/OSSIO-Full-HT-Clearance-Press-Release.pdf