Innovasis Receives FDA 510(k) for Ax Standalone ALIF System

By Julie A. Vetalice

Innovasis received FDA 510(k) clearance to market Ax™, a standalone system for anterior lumbar interbody fusion. The company claims to be the first to receive clearance for a standalone ALIF system made from Invibio's PEEK-OPTIMA™© HA Enhanced polymer.

This is the second PEEK-OPTIMA HA Enhanced device marketed by Innovasis, following a 1Q17 launch of PxHA™ for posterior lumbar interbody fusion.

Ax features a tapered leading edge to ease implant insertion within limited anatomical space, and a slightly convex profile to match spinal anatomy and provide a stable anti-migration surface during fusion.

Source: Innovasis, Inc.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory