Icotec Vader Pedicle System Additions Cleared

The FDA has granted 510(k) clearance to icotec’s Vader pedicle system to include 4.5 mm diameter pedicle screws and extended carbon/polyether ether ketone (PEEK) rods for use in patients with spinal tumors.

The pedicle system includes screws in range of diameters, between 4.5 mm and 7.5 mm, with lengths of 25 mm to 60 mm and rods up to 300 mm in length.

The X-ray translucent implants expand treatment options and allow for safer tumor care, the company said.