Globus Medical Receives FDA Clearance for ExcelsiusFlex? and ACTIFY? 3D Total Knee System
18 July 2024
Globus Medical, has received FDA 510(k) clearance for its ExcelsiusFlex™ platform, which includes a Total Knee Arthroplasty (TKA) application.
This new robotic navigation system expands their Excelsius™ ecosystem, enhancing surgical precision, resection accuracy, and procedural flexibility in TKA.
The clearance also encompasses the ACTIFY™ 3D Total Knee System, designed to integrate seamlessly with ExcelsiusFlex™.
ExcelsiusFlex™ assists surgeons in primary TKA procedures by guiding resections based on pre-planned implant placements, offering multiple workflows and jig-less resections. The system's streamlined software aims to optimize procedural efficiency.
The ACTIFY™ 3D Total Knee System complements these capabilities with its contemporary design, featuring options for cementless reconstruction, anatomical fit, and a porous lattice interface for enhanced fixation.
It offers a range of implants and instruments to accommodate diverse patient anatomy and surgeon preferences.
The significance of these innovations: "With ExcelsiusFlex™ and ACTIFY™ 3D, we are introducing next-generation robotic and implant technologies to the orthopedic market.
These systems provide precision, efficiency, and flexibility, setting a new standard for patient care."
Following FDA clearance, Globus Medical is preparing for commercial release to meet the increasing demand in orthopedic surgery.
Source: globusmedical.com