Globus Gets FDA OKs for ExcelsiusFlex Robotic Navigation & Actify 3D Total Knee

Globus Medical has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its ExcelsiusFlex with total knee arthroplasty (TKA) application and Actify 3D total knee system to pair with it.

ExcelsiusFlex assists surgeons in primary TKA for robotically-guided resections based on their implant placement planning. Its unrestricted jig-less resections and multiple workflows help restore control of the saw and procedure to the surgeon.

When used with Globus’ ExcelsiusHub, ExcelsiusFlex is an aid to precisely locate anatomical structures and for tool holder spatial positioning and orientation. This way, surgeons can navigate and/or guide compatible instruments, provided the needed fiducial markets and rigid patient anatomy can be identified on CT scans, fluoroscopy, or directly acquired anatomical structures.

The Actify 3D knee pairs cementless reconstruction with an anatomic fit. It’s additive engineered, combining strength and a porous lattice interface. The system touts a suite of implants and instruments to accommodate surgeon preference and varying anatomies, as well.

The company said it will soon commercially release ExcelsiusFlex and Actify 3D and is ramping up production.

“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.”