Zimmer Spine, a division of Zimmer Holdings, announced the recent 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.
"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."
The modular stand-alone Optio-C System offers secure fixation with no profile. The Optio-C System is comprised of one Anterior Cervical Plate, three bone screws and either a PEEK IBFD or structural allograft/autograft. The Optio-C Device is secured by an anti-migration system that is designed to maintain no profile. The system is also designed to maximise fusion with a unique load-sharing interface and multiple implant footprints. Because it has no profile, soft tissue irritation is reduced for less invasive 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, the Optio-C System takes cervical stand-alone devices to the next level.