Musculoskeletal company Globus Medical has received the US Food and Drug Administration (FDA) 510(k) clearance for ExcelsiusFlex and ACTIFY 3D Total Knee System.
ExcelsiusFlex is a new robotic navigation system designed for total knee arthroplasty (TKA) application.
The new platform joins Globus Medical’s Excelsius ecosystem, which provides surgeons with control, precision in resection, and procedural flexibility in total knee arthroplasty.
ExcelsiusFlex is engineered to support surgeons in primary total knee arthroplasty procedures by guiding robotically controlled resections based on implant placement planning.
It offers multiple workflows and jig-less resections to restore saw control and procedural management to the surgeon, supported by streamlined user software for efficient operations.
The ACTIFY 3D Total Knee System features advanced implant technology designed to complement ExcelsiusFlex.
The system is a contemporary solution for total knee replacement, combining cementless reconstruction with operational efficiency and anatomical precision.
Engineered for both manual and robotic-assisted workflows, ACTIFY 3D integrates strength with a porous lattice interface conducive to cementless fixation.
Additionally, the system offers a range of implants and instruments, accommodating surgeon preferences and varying anatomies in a diverse patient population.
Globus Medical CEO and president Dan Scavilla said: “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.
“The precision, efficiency, and flexibility these systems offer will help to provide surgeons a best-in-class solution for treating patients.”
The use of ExcelsiusFlex in conjunction with ExcelsiusHub aids precise anatomical structure location and surgical tool positioning during orthopaedic procedures.
Compatible with ExcelsiusFlex are GENflex2 and ACTIFY Total Knee System for total knee arthroplasty.
Additionally, the system aids in locating anatomical structures for navigating surgical instruments in open or percutaneous procedures, using CT scans, fluoroscopy, or direct acquisition.
ACTIFY Total Knee System and ACTIFY 3D Total Knee System are intended for single use in skeletally mature patients undergoing joint reconstruction.
Globus Medical, which is based in Pennsylvania, is now increasing production and planning for commercial launch soon.
