Orthopaedic fixation company Ossio has received 510(k) market clearance from the Food and Drug Administration (FDA) for its OSSIOfiber Bone Pin Family.
The technology features a proprietary bio-integrative material aimed to provide stability and secure bone fixation during the healing process. Its first use will be in the foot and ankle segment for the treatment of forefoot conditions.
Bob Baravarian, DPM, assistant clinical professor, UCLA School of Medicine, and director, University Foot and Ankle Institute, Santa Monica said: “OSSIO has a revolutionary new platform that will change the way we think about orthopaedic fixation for both bone and soft tissue. Surgical procedures to treat forefoot conditions are increasing in frequency as the population ages. While these procedures are considered to be effective, they can be associated with secondary implant removal surgeries due to mechanical failure, irritation and pain. OSSIOfiber has the potential to be a true game-changer, with pre-clinical studies demonstrating its mechanical strength and bio-integrative nature.”
The OSSIOfiber Bone Pin Family contains the OSSIOfiber Intelligent Bone Regeneration Technology, a material that aims to be the first credible replacement to permanent fixation implants, and is made from a proprietary natural mineral fibre matrix, with bio-integrative material properties.
Initially, the mechanical strength of the novel implant is significantly higher than cortical bone, and its performance supports bone regeneration throughout the healing process. It then gradually transfers load to the native bone following the critical rehabilitation phase.
As confirmed in pre-clinical studies, full integration into the surrounding anatomy takes place within approximately 18-24 months, leaving only native bone behind with no residual hardware.
Metal implants represent the current standard of care in orthopaedic fixation; however, permanent hardware creates a sub-optimal healing environment, which can lead to patient dissatisfaction and increasing healthcare costs due to post-operative complications and secondary removal surgeries.
Stuart Miller, orthopaedic surgeon and assistant professor at Johns Hopkins University School of Medicine, Baltimore, said: “An implant that maintains its strength through the known healing timeline, and is then completely integrated into the surrounding anatomy with no adverse inflammation is a real breakthrough for surgeons and the patients we treat.”
The product is expected to commercially launch in the United States in the second quarter of 2019.
Brian Verrier, CEO of Ossio, said: “Today’s FDA clearance of the OSSIOfiber Bone Pin Family marks a significant milestone for our company, as we bring a new category of orthopaedic fixation to the U.S. market. 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 orthopaedic fixation by encouraging natural bone healing that avoids unnecessary hardware removal surgeries and improves the overall healthcare economics of orthopaedics. This regulatory achievement supports our overall mission to transform the patient experience.”