FDA grants 510(k) clearance for Zimmer PSI Shoulder system

26 August 2013 (Last Updated August 26th, 2013 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Zimmer Patient Specific Instruments (PSI) shoulder system.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Zimmer Patient Specific Instruments (PSI) shoulder system.

The PSI shoulder system helps surgeons develop a customised surgical plan for each patient by using 3D visualisation software. It complements Zimmer's Trabecular Metal Reverse base plate implant system, designed for reverse shoulder arthroplasty (RSA) procedures.

The system also provides patient-specific surgical instrument guides to facilitate placement of the implant corresponding to the personalised surgical plan. By using these plans, surgeons can size and position the implant for placement, and can even prepare bones and position screws for implant placement.

Zimmer Extremities vice president and general manager Roberto Munoz said that reverse shoulder arthroplasty helps to restore function and alleviate pain for thousands of patients each year.

"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," Munoz added.

Zimmer PSI Shoulder has been available to only a limited number of surgeons in Europe since May. With FDA clearance in place, the Indiana-based medical device firm can market the Zimmer PSI shoulder system to surgeons throughout the US.

AZ-Monica hospital's Dr Olivier Verborgt, who has handled several Zimmer PSI Shoulder cases, said: "The planning software and patient-specific instrument guides help you think about what you want to do in the operating room, and then actually do it."