US-based medical device company Zimmer Biomet has received the US Food and Drug Administration (FDA) 510(k) approval for its Identity Shoulder System.
The Identity system is indicated for anatomic, reverse and revision shoulder replacement.
It is a convertible system that leverages advanced technologies to alleviate pain and optimise range of motion.
Zimmer Biomet designed the Identity Shoulder System based on the traditional inlay and onlay reconstruction technique used in reverse shoulder arthroplasty.
The system provides eight humeral tray combinations, increasing the surgeons’ options for aligning the humerus with the glenoid, without lengthening the arm.
It allows for 5mm of additional joint space below resection, which facilitates potential revision procedures in the future.
The Identity Shoulder System enables surgeons to devise and execute a patient-specific surgical plan precisely, said Zimmer Biomet.
Zimmer Biomet chief operating officer Ivan Tornos said: “The FDA clearance of the Identity Shoulder System is exciting because it offers surgeons a highly adaptable solution for anatomic, reverse and revision procedures to help patients optimise natural shoulder movement.
“This significant milestone adds to progress in our growing Sports Medicine, Extremities and Trauma (S.E.T.) portfolio, a critical area of focus as we expand our position as a global leader in innovative medical technologies that maximize mobility.”
Zimmer Biomet said that its new Identity Shoulder System uses the same technologies used in its portfolio of shoulder systems
The system leverages Versa-Dial for infinite humeral head offset placement, and Alliance Glenoid for a wide range of glenoid options.
Zimmer Biomet the system expands its upper extremities portfolio, which includes the Comprehensive Nano Stemless Shoulder and the Signature ONE Surgical Planning System.
Columbia University department of orthopaedic surgery chair William N Levine said: “The Identity Shoulder System was designed to help surgeons restore the centre of rotation and achieve optimal range of motion after reverse shoulder replacements, the main goal of these procedures.
“Shoulder specialists will value this system’s adaptability and flexibility to support their unique surgical approaches and complement diverse patient anatomies.”
