The US Food and Drug Administration (FDA) has issued 510(k) clearance for Globus Medical’s ExcelsiusFlex with Total Knee Arthroplasty application and the ACTIFY 3D Total Knee System.

ExcelsiusFlex is designed to support surgeons in primary total knee arthroplasty. It offers robotically guided resections based on pre-planned implant placement.

The robotic navigation platform also provides multiple workflows and jig-less resections, giving surgeons greater control over the procedure.

Globus Medical’s ACTIFY 3D total knee system combines cementless fixation with operative efficiency and anatomical fit.

It is engineered for strength and features a porous lattice interface, suitable for both manual and robotic-assisted workflows. The system includes a comprehensive suite of implants and instruments.

With these FDA clearances, Globus Medical is preparing for increased production and the commercial launch of these systems.

When used with ExcelsiusHub, the ExcelsiusFlex platform aids in locating anatomical structures and positioning surgical tools during orthopaedic procedures, provided that fiducial markers and rigid patient anatomy are identifiable.

The ExcelsiusFlex is compatible with GENflex2 and ACTIFY Total Knee Systems while the ExcelsiusHub assists in navigating surgical instruments in various procedures.

Globus Medical president and CEO 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 orthopaedic market.

“The precision, efficiency, and flexibility these systems offer will help to provide surgeons a best-in-class solution for treating patients.”