Zimmer Biomet announced Tuesday that it received 510(k) clearance from the Food and Drug Administration for a new shoulder replacement system that the company says will help surgeons tailor their approach to an individual patient’s anatomy.
The company’s Identity Shoulder System was designed to help surgeons restore rotation and a patient’s range of motion after reverse shoulder replacements, where a surgeon attaches a plastic socket to the upper arm bone and an artificial ball to the shoulder blade.
“Shoulder specialists will value this system's adaptability and flexibility to support their unique surgical approaches and complement diverse patient anatomies," Dr. William Levine, chair of the Department of Orthopedic Surgery at Columbia University who helped develop the device, said in the press release.
The system provides eight humeral tray combinations that give surgeons more options for aligning the humerus with the shoulder socket without lengthening the arm. The device was also designed to allow adaptability in the event of future shoulder surgeries, by allowing 5 mm of additional joint space below resection.
The launch is expected to be a significant one for the company, with Zimmer’s Chief Operating Officer Ivan Tornos saying in an Aug. 2 earnings call that it would be the company’s “biggest shoulder launch in the last five years.”
“This is going to be a much more customizable shoulder for a more personalized feel for the patient that should optimize movement in the shoulder,” CEO Bryan Hanson said during the call.
Zimmer Biomet’s sports medicine, extremities and trauma segment, which includes shoulder replacements, had sales of $446.4 million last quarter, a 3.4% decrease from the prior-year period.
In an emailed statement, the company said it expects to make the shoulder system available in the U.S. in the fourth quarter.