Alphatec Spine receives FDA 510(K) market clearance for two new products


Alphatec Spine has announced that it has recently received 510(k) market clearance from the FDA for two new products in the company’s new product pipeline

These products are an anchored, anterior cervical interbody device, called Pegasus, which offers single-step deployment of the anchoring blades without the need for impaction; and a new minimally invasive surgery (MIS) system called ILLICO FS Facet Fixation System, which enables spinal surgeons to immobilise and stabilise spinal segments without the need for pedicle screw and rod constructs.

Additionally, Alphatec said that it has received Shonin approval in Japan from the Pharmaceuticals and Medical Devices Agency to market and sell three lines of its novel PEEK spinal spacers, including the Novel SD, the Novel LCC and the Novel TL, which are used in posterior spinal fusion procedures. PEEK, or polyetheretherketone, is a radiolucent material containing radiographic markers, which enhance interbody visualization and alignment during the fusion process.

“I am pleased to announce these important new developments related to our new product commercialisation strategy at Alphatec Spine,” said Les Cross, Chairman and CEO of Alphatec Spine. Our initiatives to strengthen the top-line growth of the Company through robust internal product development, acquisitions and license arrangements, and continued global expansion are gaining momentum. Our new Pegasus anchored cervical interbody device and ILLICO FS system represent key additions to our cervical and MIS offerings in the U.S., respectively.

“In Japan, product registration has been a long and complex process and we are pleased to have achieved that significant milestone for our novel PEEK spinal spacer systems, complementing the strong sales presence we have already established there.”