AUDUBON, PA — Globus Medical, Inc. (NYSE: GMED) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ExcelsiusFlex™ robotic navigation platform, tailored for Total Knee Arthroplasty (TKA). This addition enhances the existing Excelsius™ ecosystem, providing surgeons with greater control, precision in resections, and procedural flexibility in knee surgeries. The company also announced that the ACTIFY™ 3D Total Knee System, designed to pair with ExcelsiusFlex™, has secured 510(k) clearance.
ExcelsiusFlex™ assists surgeons in primary total knee arthroplasty by enabling robotically guided resections based on pre-planned implant positions. It offers multiple workflows and unrestricted jig-less resections, which help surgeons maintain control over the saw and the procedure. The user-friendly software aims to streamline and enhance procedural efficiency.
The ACTIFY™ 3D Total Knee System is a modern knee replacement solution designed for both cementless reconstruction and operational efficiency. It can be used in both manual and robotic-assisted workflows. The system’s additive engineering combines strength with a porous lattice interface conducive to cementless fixation, addressing different surgeon preferences and patient anatomies.
“With the addition of ExcelsiusFlex™ and ACTIFY™ 3D, we look forward to introducing next generation robotic technology along with the next generation of implant technology to the orthopedic market,” said Dan Scavilla, president and CEO of Globus Medical. “The precision, efficiency, and flexibility these systems offer will help to provide surgeons a best-in-class solution for treating patients.”
With these FDA clearances, Globus Medical is gearing up for production and preparing for a commercial launch in the near future.
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