Zimmer Receives FDA Clearance For Patient Specific Instruments (PSI) Shoulder
Zimmer Holdings, Inc., a world leader in musculoskeletal care, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Zimmer® Patient Specific Instruments (PSI) Shoulder system to complement its Trabecular Metal™ Reverse Shoulder system for reverse shoulder arthroplasty (RSA) procedures. Zimmer PSI Shoulder utilizes 3D visualization software to allow a surgeon to create a customized surgical plan for each patient, and then provides patient-specific surgical instrument guides to facilitate placement of the implant corresponding to the personalized surgical plan. Zimmer PSI Shoulder has been available to a limited number of surgeons in Europe since May and it will now be made available to shoulder surgeons across the United States.
"Reverse Shoulder Arthroplasty has helped restore function and alleviate pain for thousands of patients each year," said Roberto Munoz, Vice President and General Manager, Zimmer Extremities. "But the primary challenges remain on the glenoid. With PSI Shoulder, we present our surgeon customers with a powerful new tool to plan the glenoid side of the surgery with the patient's unique anatomy in full view and functional needs in mind, resulting in a physical reference in the operating room to complete the surgery with confidence."
Developed in collaboration with surgeons worldwide, Zimmer® PSI Shoulder enables the surgeon to plan the implant size and position, as well as the bone preparation, even the positioning of the screws.
"Zimmer's PSI Shoulder makes you look at the patient in an entirely different way," said Dr. Olivier Verborgt, of AZ-Monica hospital, Antwerp Belgium, who has performed several Zimmer PSI Shoulder cases to date. "The planning software and patient-specific instrument guides help you think about what you want to do in the OR, and then actually do it."
Zimmer® PSI Shoulder is designed to complement Zimmer's Trabecular Metal™ Reverse base plate implant system, which has been leading the RSA market for the last two years. Zimmer's proprietary Trabecular Metal™ Technology is designed to provide optimal porosity and a friction fit for the implant into the glenoid bone, while supporting biologic ingrowth.