FDA regulators gave a thumbs-up to Zimmer’s (NYSE:ZMH) Patient Specific Instruments shoulder system, a personalized shoulder surgery planning system designed to complement the company’s Trabecular Metal Reverse Shoulder system for reverse shoulder arthroplasty procedures.
Zimmer’s PSI system, which received 510(k) clearance from the FDA this month, uses 3D-visualization software to help surgeons plan the implant size and position, bone preparation and the positioning of the screws, according to a press release from the Warsaw, Indiana- headquartered company.
"Reverse Shoulder Arthroplasty has helped restore function and alleviate pain for thousands of patients each year," extremities vice president and general manager Roberto Munoz said in prepared remarks. "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."
The device has been available to a limited number of surgeons in Europe since May, Zimmer said.
"Zimmer’s PSI Shoulder makes you look at the patient in an entirely different way," Dr. Olivier Verborgt, of AZ-Monica hospital, Antwerp Belgium, said in a press statement. "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’s had a few ups and down recently, including an Australian recall of its NexGen CR Complete Knee Systems over concerns about labeling. The orthopedics giant has spent some time in court as well, recently losing a $210 million verdict to rival device maker Stryker (NYSE:SYK), after a federal judge in Michigan ruled that Zimmer willfully infringed patents for wound debridement devices
