Globus Medical Receives FDA 510(k) Clearance for ExcelsiusFlex™ and ACTIFY™ 3D Total Knee System

Core Viewpoint - Globus Medical, Inc. has received FDA 510(k) clearance for its new robotic navigation platform, ExcelsiusFlex™, designed for Total Knee Arthroplasty (TKA), along with the ACTIFY™ 3D Total Knee System, enhancing surgical precision and efficiency in orthopedic procedures [3][6]. Product Developments - ExcelsiusFlex™ is engineered to assist surgeons in primary total knee arthroplasty with robotically guided resections, offering multiple workflows and unrestricted jig-less resections [4]. - The ACTIFY™ 3D Total Knee System is designed for cementless reconstruction, combining strength with a porous lattice interface for effective fixation, and provides a comprehensive suite of implants and instruments [5][11]. Market Positioning - The introduction of ExcelsiusFlex™ and ACTIFY™ 3D aims to provide next-generation robotic and implant technology to the orthopedic market, enhancing precision, efficiency, and flexibility for surgeons [6]. - With the FDA clearances, Globus Medical is preparing for commercial release and ramping up production of these innovative systems [6]. Indications for Use - ExcelsiusFlex™ is intended to aid in the precise location of anatomical structures and assist in planning the position of implant components during orthopedic procedures [7][9]. - The compatible TKA implant systems with ExcelsiusFlex™ include GENflex2™ and ACTIFY™ Total Knee System, which are indicated for various conditions including osteoarthritis and post-traumatic degenerative problems [8][11]. Company Overview - Globus Medical is a leading musculoskeletal company focused on developing technologies and products that address unmet clinical needs and promote patient healing [12].