Alphatec Holdings receives 510(k) clearance for interbody fusion device

The FDA has issued 510(k) clearance for Alphatec Holdings Inc. to market and sell its Alphatec Solus internal fixation anterior lumbar interbody fusion device in the United States.

Featuring two counter-rotating titanium blades, which deploy into adjacent vertebrae on a zero-degree axis, locking the device in place, the anterior lumbar interbody fusion device has four points of fixation. According to a company press release, the anterior lumbar interbody fusion device provides enhanced segmental stability with a simplified surgical technique. It also provides substantial spacing to insert the bone graft to promote rapid fusion at the site.