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OSSIO announces FDA 510(k) clearance for bio-integrative orthopedic implant system
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OSSIO announced it received FDA 510(k) clearance for the OSSIOfiber bone pin family.
According to a company press release, the technology features bio-integrative material that reportedly offers stability and secure bone fixation during the healing process and leaves no permanent hardware. Its first commercial use is intended for the treatment of forefoot conditions. According to the company, the technology promotes bone regeneration throughout healing and then transfers load to naïve bone after the rehabilitation phase.
“Today’s FDA clearance of the OSSIOfiber bone pin family marks a significant milestone for our company, as we bring a new category of orthopedic fixation to the U.S. market,” Brian Verrier, CEO of OSSIO, said in the release. “We look forward to partnering with surgeons throughout the United States to integrate the OSSIOfiber platform into their surgical treatment options, ultimately changing the current standard of care in orthopedic fixation by encouraging natural bone healing that avoids unnecessary hardware removal surgeries and improves the overall health care economics of orthopedics. This regulatory achievement supports our overall mission to transform the patient experience.”
OSSIO anticipates the U.S. commercial launch of the OSSIOfiber bone pin family to occur in the second quarter of 2019.
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