News

Globus Medical, Inc., a leading provider of musculoskeletal solutions, has announced that it recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its ExcelsiusFlex™ with Total Knee Arthroplasty (TKA) application. This new robotic navigation platform enhances the Excelsius™ ecosystem, designed to provide surgeons with greater control, precision in resections, and flexibility in TKA procedures. Additionally, the ACTIFY™ 3D Total Knee System, the latest in implant technology to pair with ExcelsiusFlex™, has also obtained 510(k) clearance.

ExcelsiusFlex™ is engineered to assist surgeons in primary total knee arthroplasty procedures by enabling robotically guided resections based on their implant placement planning. It offers multiple workflows and jig-less resections, allowing surgeons to maintain control of the saw and the procedure. The streamlined user software is designed to facilitate efficient operations.

The ACTIFY™ 3D Total Knee System is a modern total knee solution intended to combine cementless reconstruction with operative efficiency and an anatomical fit. Suitable for both manual and robotic-assisted workflows, ACTIFY™ 3D is engineered with a strong, porous lattice interface that supports cementless fixation. The system includes a comprehensive range of implants and instruments to cater to individual surgeon preferences and diverse 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,” commented 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 510(k) FDA clearances, Globus Medical is ramping up production and preparing for a commercial release in the near future.


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