Globus Medical has been actively expanding its product portfolio and capabilities in 2024, marked by key FDA clearances and strategic product launches. These advancements underscore the company's commitment to innovation in orthopedic and spinal surgery.
FDA Clearance for ExcelsiusFlex Robot
The ExcelsiusFlex orthopedics robot received FDA 510(k) clearance, positioning it as a significant tool for stereotactic guidance during orthopedic joint or spine surgeries. This clearance allows surgeons to use the robot for precise navigation, potentially improving surgical accuracy and patient outcomes. The ExcelsiusFlex is designed to enhance the precision of instrument placement, which is critical in both joint and spine procedures.
Approval for Use with Actify 3D Total Knee System
Further expanding its robotic surgery applications, the ExcelsiusFlex robot was approved for use with the Actify 3D total knee system. The Actify system focuses on cementless reconstruction, operative efficiency, and achieving an optimal anatomic fit. By integrating the ExcelsiusFlex robot, surgeons can potentially enhance the accuracy and reproducibility of total knee arthroplasty, leading to improved implant stability and patient satisfaction.
Launch of Adira Extreme Lateral Interbody Fusion Plate System
Globus Medical also launched the Adira extreme lateral interbody fusion (XLIF) plate system, marking the company's first product launch compatible with its expanded lateral interbody portfolio. The Adira system is designed with a simplified insertion workflow and a rigid coupling mechanism to facilitate the alignment of plates over interbody spacers. This system aims to streamline the XLIF procedure, potentially reducing operative time and improving fusion rates.
Other Developments
In addition to these product-related milestones, a judge upheld a 2023 patent infringement verdict in favor of Globus Medical, reinforcing the company's intellectual property rights. Globus Medical also addressed FDA concerns regarding its Excelsius GPS spine robot, demonstrating its commitment to regulatory compliance and product safety. These developments, combined with leadership changes including the appointment of Keith Pfeil as COO, highlight a dynamic period for Globus Medical as it continues to innovate and expand its presence in the orthopedic and spinal surgery market.
