Orthopedic device company Ossio said yesterday that it won FDA 510(k) clearance for its OssioFiber BonePin family of products.
The Woburn, Mass.-based company said that products in the OssioFiber BonePin family feature a proprietary bio-integrative material that it claims provides stability and secures bone fixation during healing with no permanent hardware left behind.
The company said its newly cleared OssioFiber BonePins feature a proprietary fixation material, composed of a natural mineral fiber matrix, that it says aims to be the “first credible replacement to permanent fixation implants.”
“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,” Bob Baravarian of the UCLA School of Medicine and University Foot and Ankle Institute said in a prepared statement.
“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,” Dr. Stuart Miller of MedStar Union Memorial Hospital and Johns Hopkins University School of Medicine said in a prepared release.
Ossio said it plans to commercially launch the OssioFiber BonePin family of devices during the second quarter of this year.
“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. 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. This regulatory achievement supports our overall mission to transform the patient experience,” CEO Brian Verrier said in a press release.
The company added that it has launched a multi-center clinical trial assessing the safety and performance of its OssioFiber hammertoe fixation implant, having already and enrolled and treated the first patient. Ossio said that results from the trial will support its CE Mark application for the device, which it expects to file next year.
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