FDA Clears Zimmer’s Optio-C® Anterior Cervical System for use with Structural Allograft/Autograft

Zimmer Spine, a division of Zimmer Holdings, Inc., has announced the U.S. FDA 510(k) clearance of the Optio-C Anterior Cervical Plate for use with structural allograft/autograft as a stand-alone cervical system for cervical fusion procedures.

Background

Zimmer’s Optio-C System is comprised of one Anterior Cervical Plate, three bone screws and either a PEEK IBFD or structural allograft/autograft (pictured). The modular stand-alone system offers secure fixation with “no profile”, being secured by an anti-migration system.

Optio-C is also designed to maximize fusion with a unique load-sharing interface and multiple implant footprints. Because it has no profile, soft tissue irritation is reduced for less invasive Anterior Cervical Discectomy and Fusion (ACDF) procedures, and it eliminates the need for additional plating when addressing adjacent level disease. With plate strength equivalent to a traditional cervical plate with no profile, stability through a three-screw fixation design, Zimmer Spine says the Optio-C System takes cervical stand-alone devices to the next level.

Company comments

“Zimmer is pleased to offer the industry’s first no profile stand-alone cervical device with structural allograft/autograft in one modular system. In follow up to the PEEK option we launched earlier this year, we have expanded the Optio-C System to include multiple materials,” said Steve Healy, President of Zimmer Spine. “Surgeons now have a choice to use structural allograft/autograft or PEEK in their stand-alone ACDF procedures.”

Source: Zimmer Spine, PR Newswire

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