- Ossio announced Monday it received FDA 510(k) clearance for a bioabsorbable orthopaedic fixation implant for foot and ankle conditions that leaves behind no permanent hardware. The material integrates into the surrounding anatomy in 18 to 24 months.
- The fixation implant, made from a mineral fiber matrix, is intended as an alternative to permanent fixation devices to restore patient mobility, the company said. Ossio plans to pursue multiple applications for the material in the distal extremity, trauma, sports, reconstruction, pediatrics and spine segments.
- The company expects to launch the Ossiofiber Bone Pin Family in the United States in the second quarter of 2019.
Ankle fractures are the fifth most common type of bone fracture, accounting for about 9% of all fractures in the human body, according to one study. An estimated 260,000 Americans suffer from an ankle fracture each year, and about 25% require surgery.
Metal implants are the current standard of care in orthopaedic fixation but sometimes lead to complications when the bone doesn't heal properly. Bioabsorbable implants have been developed with the aim of eliminating hardware removal surgeries that are sometimes necessary as a result. However, various bioabsorbable materials have failed to provide the needed strength to support bone healing or have released acidic byproducts that cause inflammation at the surgery site.
Ossio claims its bone regeneration technology has created a material that is stronger than cortical bone and integrates into the native anatomy without adverse biological response. The Ossiofiber can be implanted using existing surgical techniques, the company 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," Stuart Miller, orthopaedic surgeon at MedStar Union Memorial Hospital and assistant professor at Johns Hopkins University School of Medicine, said in a press release.
FDA cleared the material for the alignment and fixation of bone fractures, osteotomies, arthrodesis and bone grafts.
Ossio's development headquarters is in Caesarea, Israel, and its commercial headquarters is in Woburn, Massachusetts.