The FDA has granted a 510(k) clearance to Ossio for its family of bio-integrative bone pins, which secure broken bones during the healing process while leaving no permanent hardware behind.
The pins are made of a natural mineral fiber matrix that aims to replace the more permanent, metal fixation implants used in fractures, bone cuttings or removals, joint fusions and bone grafts.
The company believes its Ossiofiber platform will have broad applications in orthopedics, with its first commercial launches planned for the foot and ankle segment and forefoot treatments where subsequent hardware removal surgeries are common.
“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 healthcare economics of orthopedics,” Ossio CEO Brian Verrier said in a statement.
Based in both Israel and Boston, Ossio plans to commercially launch the bone pin family in the U.S. in the second quarter of this year.
According to the company, the platform does not require any changes to surgeons’ existing techniques. During initial insertion, the mechanical strength of the integrative implant is higher than cortical bone, while gradually transferring load to the native bone as it heals. In preclinical studies, the implant’s full integration into the anatomy takes 18 to 24 months, leaving only native bone behind, with no major inflammatory responses.
Currently, metal implants represent the standard-of-care in orthopedic fixation, though permanent hardware can impair the healing process as well as weaken the bone surrounding the implant. In addition, they can lead to post-operative complications and secondary removal surgeries following implant failure, irritation or pain.
Meanwhile, Ossio is conducting a European clinical trial for a hammertoe fixation implant made of the same material, aimed at acquiring a CE mark in 2020. The company intends to pursue multiple applications in the distal extremity, trauma, sports, reconstruction, pediatrics and spine segments through the development of pins, screws and plates.