Alphatec Spine Receives FDA 510(K) Market Clearance for Its Alphatec Solus

CARLSBAD, Mar 12, 2013 (GLOBE NEWSWIRE via COMTEX) — Alphatec Holdings, Inc. , the parent company of Alphatec Spine, Inc., a company with a mission to provide physician-inspired solutions for patients with spinal disorders, announced today that the Company has received clearance from the U.S. Food and Drug Administration (FDA) to market and sell its unique and patented Alphatec Solus internal fixation anterior lumbar interbody fusion (ALIF) device. The device’s 510(K) application was filed with the FDA during the fourth quarter of 2012.
The Alphatec Solus ALIF device features two counter-rotating titanium blades, which deploy into adjacent vertebrae on a zero-degree axis, locking the device in place. This provides four points of fixation delivered in what the Company believes is an industry leading single step. The patented device is designed to provide enhanced segmental stability with a simplified surgical technique, while providing substantial spacing to insert bone graft to help promote rapid fusion at the site. Alphatec Solus is designed to provide fast, easy and effective stabilization for a surgeon’s ALIF procedures.
“We are extremely pleased to announce that the Alphatec Solus ALIF system will soon be available for commercial release within the United States,” said Les Cross, Chairman and CEO of Alphatec Spine. “We launched Alphatec Solus in Europe in January this year and thus far it has been a success. Our product development programs will remain a collaborative effort between spine surgeons and our internal development group to ensure that the latest product innovations keep advancing improved patient care in the operating room.”
According to Millennium Research Group, the market for internal fixation ALIF spacer devices is estimated to be approximately $129 million in 2013, representing approximately half of the total market for the ALIF spacer devices.