Custom Spine Receives FDA Clearance for Cervical Interbody Spacer Device

Custom Spine has received FDA clearance to market PATHWAY ACIF, an anterior cervical interbody spacer, which compliments the company’s low-profile anterior cervical plate system, Regent ACP, released this past November, according to a Custom Spine news release.

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PATHWAY ACIF, with its large footprint, was designed to provide structural support in the disc space while allowing for a generous amount of autograft containment to promote fusion, according to the release. The spacer is manufactured from PEEK-OPTIMA, a biocompatible, radiolucent material, and is available in both parallel and lordotic profiles with a wide range of heights.  

Custom Spine developed the system’s dual ended trial feelers and the toggle free interface between the implant and inserter provide the surgeon with system versatility and controlled implantation, according to the release.

Read the Custom Spine release on PATHWAY ACIF.

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