Globus Medical Receives FDA 510(k) Clearance For ExcelsiusFlex And ACTIFY 3D Total Knee System
Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced it recently received 510(k) clearance by the U.S. Food and Drug Administration (FDA) for ExcelsiusFlex™ with Total Knee Arthroplasty (TKA) application. This new robotic navigation platform joins the already best-in-class Excelsius™ ecosystem, designed to offer surgeons control, resection accuracy, and procedural flexibility in Total Knee Arthroplasty. Additionally, ACTIFY™ 3D Total Knee System, the latest in implant technology that will pair with ExcelsiusFlex™, has also received 510(k) clearance.
ExcelsiusFlex™ is engineered to assist the surgeon in primary total knee arthroplasty procedures for robotically guided resections based on their implant placement planning. Multiple workflows and unrestricted jig-less resections are offered to restore control of the saw and the procedure to the surgeon. Streamlined user software is designed to enable efficient procedures.