AERO MIS Facet Fusion System

The AERO MIS Facet Fusion System is a posterior spinal fusion device containing various sized facet screws for bilateral stabilization of facet joints from C2 through S1 spinal levels. It is indicated for treating spondylolisthesis, spondylolysis, pseudoarthrosis/failed fusions, and degenerative disc disease, and is intended for use with bone graft material.

The AERO MIS Facet Fusion System is contained in a device tray with various sized facet screws and orthopedic instruments to accommodate different facet joint sizes and geometries. Like the predicate Ion Facet Screw System, it is supplied non-sterile but can be sterilized via steam sterilization prior to use for posterior surgical treatment of the facet.

Static cantilever bending per ASTM F2193, static pushout per ASTM F543, sterilization and reprocessing validation per ISO 17665-1, and biocompatibility evaluation per ISO 10993-1.

The subject device shares identical indications for use, design approach, materials, and performance characteristics as the predicate Ion Facet Screw System (K211855). Both devices are facet screw systems supplied in device trays that can be steam sterilized and intended for posterior facet stabilization. Performance testing demonstrates equivalent mechanical properties and biocompatibility, establishing substantial equivalence across all relevant parameters.