FDA clears absorbable foot and ankle implant (MedTechDive)
Ossio website
Dive Brief:
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.
https://youtu.be/QhiHflP1nGE
Dive Insight:
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 d...
