OSSIO has announced the US launch and first commercial use of OSSIOfiber Bone Pin Family for alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts.
OSSIO said that the first commercial cases of hammertoe repairs were performed by foot and ankle surgeons Gregory Berlet, Christopher Hyer, and Mark Prissel, at Polaris Surgery Center in Westerville, Ohio.
In January 2019, the OSSIOfiber Bone Pin Family has received 510(k) market clearance from the US Food and Drug Administration (FDA) and the initial product offering is applicable for use in the foot and ankle segment for the treatment of forefoot conditions where hardware removal surgeries are prevalent.
The OSSIOfiber offers a new category of non-permanent fixation material with intelligent bone regeneration technology, featuring a bio-integrative material that provides stability and secure bone fixation during the healing process.
The technology allows the fixation material to be gradually integrated into the native anatomy, leaving no permanent hardware behind.
The company said that it has designed the OSSIOfiber combining effective mechanical strength and natural bone healing in a non-permanent implant, to fully incorporate into the native anatomy without any adverse biologic response.
Dr. Berlet said: “OSSIOfiber TM 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.”
OSSIO is planning to make OSSIOfiber available for additional procedures in limited markets in the coming weeks, and full commercialization in all states is expected to be achieved in the third quarter of 2019.
The company claimed that its OSSIOfiber technology is capable of addressing many surgical applications through the manufacturing of infinite implant designs, including pins, screws and plates.
Hyer said: “While forefoot disorders are highly treatable, secondary procedures to remove hardware are often warranted, causing a significant cost burden on the patient, physician and healthcare system as a whole. We’ve been waiting for a new option in the orthopedic fixation space for decades and OSSIOfiber shows real promise to become the first credible replacement to permanent implants.
“Having this new treatment option at the ready will fundamentally impact our approach to treating these patients by avoiding permanent device-related post-operative complications and secondary removal surgeries.”