FDA Clears PSI Shoulder System by Zimmer

Zimmer (Warsaw, IN) received clearance from FDA regulators for its Patient Specific Instruments (PSI) Shoulder system. The system uses a 3D visualization tool with the Trabecular Metal Reverse Shoulder implant to create an operational plan for surgeries. According to the company, the new device can make device placement easier.

Zimmer's PSI Shoulder entered the European market in May of this year. The company's Trabecular shoulder implant has been available for approximately two years. The Trabecular Shoulder implant uses the same technology found in hip and knee implants. As a porous bone implant, Zimmer's Trabecular Metal technology can promote biologic ingrowth. At the same time, the system promotes optimal function and overall stability.

"Reverse Shoulder Arthroplasty has helped restore function and alleviate pain for thousands of patients each year," noted Roberto Munoz, vice president of 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..."

When used with the company's planning software and patient-specific instrument guides, the PSI system is designed to match patients' specific anatomy, while providing the appropriate level of porosity and a friction to support ingrowth into the the glenoid bone.

In the first half of the year, Zimmer reported net sales of $1.7 billion. This represents a 4% increase over the first half of 2012. However, the company faces a $228 million one-time payout following the loss of a patent lawsuit against Stryker. The lawsuit alleges that Zimmer's Pulsavac Plus infringes on Stryker's intellectual property.