Israeli orthopedic medical device company OSSIO has launched the OSSIOfiber Bone Pin Family for maintenance of alignment and fixation of bone fractures, arthrodesis, bone grafts, and osteotomies.
The first commercial cases of the the OSSIOfiber Bone Pin Family was in the hammertoe repairs carried out at Polaris Surgery Center in Westerville, Ohio.
Dr Gregory Berlet, who handled the first commercial cases said: “OSSIOfiber brings forward a real paradigm shift in how we approach bone fixation. The new bio-integrative implant is truly unique in that it provides immediate stable fixation that physiologically adapts with the bone during the healing process.
“I am honored to have performed the inaugural cases in the United States together with Drs. Hyer and Prissel and look forward to adding implants made from this innovative bio-material technology to my treatment arsenal.”
The launch of the bone pin family followed the 510 (k) market clearance it received from the US Food and Drug Administration (FDA) in January 2019. The first product offering is applicable for use in the foot and ankle segment for treating forefoot conditions where hardware removal surgeries are common.
Brian Verrier – CEO of OSSIO said: “The U.S. market anticipation for OSSIOfiber has been overwhelmingly positive to date.
“We are poised to initiate broader U.S. commercialization of the implant system in the coming weeks, offering surgeons and their patients a new standard of care in orthopedic fixation.”
The OSSIOfiber Intelligent Bone Regeneration Technology, which is said to offer a new category of non-permanent fixation material, features a bio-integrative material. During the healing process and gradual integration into the native anatomy, the bio-integrative material gives stability and secures bone fixation, eventually leaving no traces of permanent hardware.
OSSIOfiber is said to combine unparalleled mechanical strength and natural bone healing in a non-permanent implant. The bone pin is designed to fully integrate into the native anatomy without any adverse biologic response.