FDA clears Ossio’s OssioFiber suture anchors for bone fixation

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…

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Ossio launches trimmable fixation nail system

Ossio today said it has launched its Ossiofiber Trimmable Fixation Nail System.

The system is designed to securely fixate bone fractures, osteotomies and arthrodeses for healing. The patient is left with a restored bone and no permanent hardware left behind. The first commercial cases were bunion and MTP fusion procedures.

Ossiofiber features strong bio integrative trimmable fixation nails in 2.4mm and 4mm diameters packaged with corresponding sterile, disposable instrumentation.

“Having successfully utilized this new biointegrative option in my own clinical practice, it is clear that the Ossiofiber Trimmable Fixation Nails have real potential to replace metal compression screws and pins in numerous orthopedic procedures, with the ability to optimize bone healing while avoiding permanent implant-related post-operative complications,” Chris Hyer, a foot and ankle surgeon in Westerville, Ohio who implanted the first Ossiofiber, said in a news release. “Thi…

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