Zimmer Biomet receives 510(k) clearance for bridge fixation system

Zimmer Biomet Holdings announced they received FDA 510(k) clearance for the Unite3D Bridge Fixation System, designed using 3D-printed technology to offer stability in foot and ankle arthrodesis.

The Unite3D Bridge Fixation System features Zimmer Biomet’s proprietary OsseoTi porous metal technology and includes an osteoconductive matrix designed to provide for biological incorporation, according to a press release. The System is made up of a solid internal framework for added strength and rigidity, and features a zero-prominence design and uniform compression along the entire length of the implant. According to the press release, the Unite3D Bridge Fixation System includes nine implant size options and single-use surgical instrumentation to efficiently address a wide spectrum of patient anatomy and clinical situations.

“The Unite3D Bridge Fixation System is unlike anything in our portfolio, and we are proud to commercialize a true innovation in this exciting clinical area,” Ben Joseph, general manager of Foot & Ankle at Zimmer Biomet, said in the release. “This powerful combination of 3D printing technology and our OsseoTi porous metal material is only the latest contribution from Zimmer Biomet’s robust innovation pipeline. We aim to serve the unique needs of patients and surgeons while expanding our presence in every category of musculoskeletal health care, including the rapidly growing market of foot and ankle treatments.”

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