Zimmer Biomet Announces FDA 510(k) Clearance for Unite3D™ Bridge Fixation System

by PRNewswire

WARSAW, Ind., Feb. 11, 2016 /PRNewswire/ -- Zimmer Biomet Holdings (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, is pleased to announce that the Company has received 510(k) clearance from the U.S. Food and Drug Administration for the Unite3D™ Bridge Fixation System, a groundbreaking 3D-printed technology designed to offer stability in foot and ankle arthrodesis (joint fusion) surgery. Featuring Zimmer Biomet's proprietary OsseoTi® porous metal technology, which mimics the architecture of cancellous bone, the Unite3D Bridge Fixation System includes an osteoconductive matrix designed to provide for biological incorporation. The Unite3D Bridge Fixation System represents an alternative to traditional surgical plates, screws and staples for a range of foot and ankle fusion procedures. 

"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," said Ben Joseph, General Manager of Foot & Ankle.  "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 healthcare, including the rapidly growing market of foot and ankle treatments."

In addition to osseointegration, the Unite3D Bridge Fixation System is made up of a solid internal framework for added strength and rigidity.  The Unite3D Bridge Fixation System also features a zero-prominence design and uniform compression along the entire length of the implant. In order to efficiently address a wide spectrum of patient anatomy and clinical situations, the Unite3D Bridge Fixation System includes nine implant size options and single-use surgical instrumentation.

To develop the Unite3D Bridge Fixation System, Zimmer Biomet collaborated with leading orthopaedic surgeons Dr. Greg Pomeroy, MD of New England Foot and Ankle Specialists and Dr. John Early, MD of Texas Orthopaedic Associates.

"By offering foot and ankle surgeons a construct for osseointegration across the entire fusion site, the Unite3D Bridge Fixation System provides a stable and durable solution for fracture and osteotomy fixation and joint arthrodesis within the midfoot and hindfoot," said Dr. Early. "Having replaced the plates, screws and surgical staples of traditional foot and ankle fusion, we also wanted to offer the intraoperative benefits of a streamlined procedure with easy-to-use and disposable surgical instruments."

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