Ossio Gets FDA’s 510(k) Clearance for its OssioFiber Suture Implants

Ossio has received the FDA’s 510(k) clearance for its OssioFiber suture anchors for the fixation of sutures to bone in a variety of orthopedic procedures.

An Israeli-American orthopedic fixation technology startup with facilities in Woburn, Mass., and in Caesarea, Israel, Ossio said it will begin marketing the OssioFiber anchors in the second quarter of this year.

The company previously received 510(k) clearances for two related products: OssioFiber compression staples for use in fixation of arthrodesis, osteotomies and fractures in hand or foot surgery; and OssioFiber compression screws for use in the maintenance of alignment and fixation of bone fractures. The staples and the screws will go on the market in the third quarter of this year, the company said.