FDA Clears Way For Zimmer Biomet Shoulder System
News Release
WARSAW — Zimmer Biomet continues to expand its products available for shoulder replacement surgery.
The Warsaw-based company on Tuesday, Sept. 20, announced U.S. Food and Drug Administration clearance of the Identity Shoulder System for anatomic, reverse and revision shoulder replacement.
The Identity Shoulder System is a convertible system that uses proprietary technologies to align each surgeon’s approach to an individual patient’s anatomy, with the goal of alleviating pain and optimizing range of motion. The latest addition to Zimmer Biomet’s portfolio of shoulder replacement systems, the Identity Shoulder System is designed to allow surgeons to devise and execute a patient-specific surgical plan with precision.
“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 optimize natural shoulder movement,” said Ivan Tornos, chief operating officer at Zimmer Biomet.
“This significant milestone adds to progress in our growing Sports Medicine, Extremities and Trauma portfolio,” he said.
The Identity Shoulder System expands on the traditional inlay and onlay reconstruction used in reverse shoulder arthroplasty by providing eight humeral tray combinations that give surgeons increased options for aligning the humerus (upper arm bone) with the glenoid (shoulder socket), without lengthening the arm. Designed to offer adaptability for potential revision procedures in the future, the Identity Shoulder System allows for 5mm of additional joint space below resection2, which gives surgeons more to work with if a revision is needed in the future.
Similar to all shoulder systems in Zimmer Biomet’s portfolio, the Identity Shoulder System uses proprietary technologies, including Versa-Dial for infinite humeral head offset placement and Alliance Glenoid for a broad range of glenoid options, to adapt to a patient’s unique anatomy.
“The Identity Shoulder System was designed to help surgeons restore the center of rotation and achieve optimal range of motion after reverse shoulder replacements – a main goal of these procedures,” said William N. Levine, M.D., chair of the department of orthopedic surgery at Columbia University’s College of Physicians and Surgeons.