Surgical products developer Zimmer Holdings has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Patient Specific Instruments (PSI) Shoulder system.
The system enables surgeons to plan the implant size and position, apart from facilitating the placement of the implant and positioning of the screws, using 3D visualization software.
In addition, the system will also enable surgeons in creating a customized surgical plan for each patient.
PSI Shoulder system, which complements the company’s Trabecular Metal Reverse Shoulder system for reverse shoulder arthroplasty procedures, has been available in the Europe on limited scale since May 2013.
The new shoulder system will now be made available to shoulder surgeons across the US.
Commenting on the approval, Zimmer Extremities vice president and general manager Roberto Munoz said with PSI Shoulder, the company presents its 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."
Zimmer’s Trabecular Metal reverse base plate implant system is based on its proprietary Trabecular Metal technology that is designed to provide optimal porosity and a friction fit for the implant into the glenoid bone, while supporting biologic ingrowth.