FDA 510(k) Market Clearance for Alphatec Solus Internal Fixation Anterior Lumbar Interbody Fusion Device
Alphatec Holdings Inc., the parent company of Alphatec Spine Inc., received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market and sell its Alphatec Solus internal fixation anterior lumbar interbody fusion (ALIF) device.
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," states Les Cross, chairman and CEO, 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.