Ossio announced today that it received the third FDA clearance for its OssioFiber product family in recent months.
Woburn, Massachusetts-based Ossio’s latest regulatory nod covers the OssioFiber suture anchors (4.75 mm-5.5 mm) for use in the fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in a variety of specific orthopedic procedures.
According to a news release, Ossio intends to initiate the U.S. launch of the OssioFiber suture anchors sometime in the second quarter of 2022.
Today’s announcement is the most recent in a series of regulatory victories for the OssioFiber intelligent bone regeneration technology product line, with OssioFiber compression staples winning FDA clearance in January 2022 and the OssioFiber compression screws garnering the same nod in December 2021. Ossio plans to launch both product lines in the third quarter of this year.
All Ossio implants include the OssioFib…