Globus Medical (Audubon, PA, USA) has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new robotic navigation platform, ExcelsiusFlex, tailored for total knee arthroplasty (TKA) applications. This platform enhances the existing Excelsius ecosystem, providing surgeons with enhanced control, precision in bone resection, and procedural versatility in TKA. Additionally, the ACTIFY 3D Total Knee System, the latest advancement in implant technology designed to complement ExcelsiusFlex, has also achieved 510(k) clearance.

ExcelsiusFlex is specifically designed to support surgeons in primary TKA by guiding robotic resections based on pre-planned implant positioning. It offers multiple workflow options and unrestricted jig-less resections, thereby returning control of the surgical saw and procedure to the surgeon. Its user-friendly software streamlines procedures for efficiency. When used with the ExcelsiusHub, ExcelsiusFlex aids in accurately identifying anatomical structures and positioning and orienting a tool holder for navigating and guiding compatible surgical instruments, assuming identifiable fiducial markers and rigid patient anatomy from CT scans or directly acquired anatomical data. The system assists surgeons in implant positioning and bone preparation during orthopedic surgeries.

The ACTIFY 3D Total Knee System introduces a modern solution for total knee replacement, blending cementless reconstruction with operational efficiency and an anatomical fit. Engineered for both manual and robotic-assisted workflows, ACTIFY 3D uses additive manufacturing to combine robustness with a porous lattice structure for cementless attachment. The system offers a complete range of implants and instruments tailored to meet the preferences of surgeons and accommodate the anatomical diversity of patients. Indicated for single use in adults with severe joint disabilities or significant pain, ACTIFY 3D addresses primary total knee replacements and revisions where osteoarthritis, osteonecrosis, rheumatoid arthritis, post-traumatic conditions, or prior surgical failures exist, provided there is adequate bone and soft tissue integrity. With the necessary 510(k) clearances obtained, Globus Medical is now increasing production and preparing for a commercial launch.

“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.” 

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