Innovasis recieves FDA 510(k) clearance for PEEK standalone Ax ALIF System

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Innovasis has become the first company to recieve US Food and Drug Administration (FDA) clearance for a standalone anterior lumbar interbody fusion (ALIF) system made from Invibio’s PEEK-Optima HA Enhanced polymer.

The polymer is exposed on all surfaces of the body of the device, including within the inner walls of the graft chamber. This is intended to promote fusion with the osteoconductive material.
Ax is an intervertebral fusion device for use in patients with degenerative disc disease at one or two contiguous levels. It features a tapered leading edge which is designed to aid implant insertion within limited anatomical space. It also features a slightly convex profile intended to match the anatomy of the spine and provide a stable anti-migration surface during the fusion process. Its large graft cavity is designed to increase the volume of autograft which can be loaded.

This is the second product made using the polymer marketed by Innovasis, whose PxHA polyaxial lumbar interbody fusion device was released at the end of 2016.