The US Food and Drug Administration (FDA) has granted 510(k) approval to Alphatec Holdings' new products, Pegasus and ILLICO FS Facet Fixation systems.
Pegasus, an anchored anterior cervical interbody device, offers single-step deployment of the anchoring blades without the need for impaction while ILLICO is a MIS system which immobilizes and stabilizes spinal segments without the need for pedicle screw and rod constructs.
In addition to the FDA clearance, the company received Shonin approval in Japan from the Pharmaceuticals and Medical Devices Agency for its Novel PEEK Spinal Spacers including the Novel SD, the Novel LCC and the Novel TL, designed for use in posterior spine fusion procedures.
PEEK, or polyetheretherketone, is a radiolucent material containing radiographic markers, which enhance interbody visualization and alignment during the fusion process, claims the company.
Alphatec Spine chairman and CEO Les Cross said the company is pleased to obtain Japanese approval, as product registration has become a long and complex process in Japan.
"I am pleased to announce these important new developments related to our new product commercialization strategy at Alphatec Spine," Cross added.
