SpineEX Sagittae Fusion System Cleared

FDA has cleared a SpineEX 510(k) for its Sagittae Lateral Lumbar Interbody (LLIF) Fusion System. The company describes the device as a personalized, adjustable expandable LLIF device designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It allows for up to 8mm of continuous in situ expansion, with up to 30mm of continuous in situ lordotic adjustment. “The large single graft chamber can be filled with bone graft material after insertion and adjustment to ensure even contact with both vertebral endplates,” SpineEX says.

The clearance adds new system instrumentation along with an updated surgical technique. It enables surgeons to better streamline the implant sizing process along with giving them the ability to adjust the anterior and posterior side of the implant independently of one another, the company says.