Zimmer Spine receives 510(k) clearance for Optio-C Anterior Cervical Plate

SAN FRANCISCO — Zimmer Spine announced its receipt of 510(k) clearance from the U.S. Food and Drug Administration for the Optio-C Anterior Cervical Plate here at the North American Spine Society’s annual meeting.

The Optio-C system is a modular, stand-alone cervical device that offers allograft/autograft and PEEK options and delivers the strength, stability and fusion potential of a traditional anterior cervical discectomy and fusion (ACDF), according to a press release issued by the company.

Offering secure fixation with no profile, the system comprises an anterior cervical plate, three bone screws and either a PEEK intervertebral body fusion device or structural allograft/autograft. The system is designed to maximize fusion with a load-sharing interface and multiple implant footprints.

Because it has no profile, soft tissue irritation is reduced for less invasive ACDF procedures, and the system eliminates the need for additional plating when addressing adjacent-level disease, according to the release.

“Zimmer is pleased to offer the industry’s first no-profile, stand-alone cervical device with structural allograft/autograft in one modular system,” Steve Healy, Zimmer Spine president, said in the release. “Surgeons now have a choice to use structural allograft/autograft or PEEK in their stand-alone ACDF procedures.”

Reference: http://www.zimmer.com.