Globus Medical, Inc. (GMED) announced on Wednesday that it has received 510(k) clearance from the FDA for both the ExcelsiusFlex and Actify 3D Total Knee System.
ExcelsiusFlex is designed to provide surgeons with enhanced control, precise cutting, and increased flexibility for robotic-assisted Total Knee Arthroplasty procedures.
The company stated that the Actify 3D Total Knee System is intended for single-use in skeletally mature individuals requiring reconstruction of severely impaired and/or extremely painful joints, typically in total knee replacement surgeries.
Globus Medical is accelerating production and gearing up for the commercial launch of these products in the near future.
