510k for Titan Reverse Shoulder System

Integra LifeSciences Holdings Corp. officials announced that the Integra Titan Reverse Shoulder System has received 510k clearance from the U.S. Food and Drug Administration (FDA). Integra expects to begin a limited market release in the United States in the third quarter of 2013, and upon CE Mark clearance in Europe, begin a full global commercial launch.

The Reverse Shoulder System is built on a unique platform stem. This platform stem simplifies the conversion of a primary total shoulder, or hemi for fracture, to a reverse shoulder, without the need to remove a stem that is well fixed in the patient's bone. The system offers fully interchangeable components, which allow all primary, reverse, and fracture humeral bodies to be used with either the press-fit or cemented platform stems. This flexibility provides surgeons with minimally invasive intraoperative options, and the ability to offer continued care for the lifetime of the patient.

William Geissler, M.D., Professor of Orthopaedic Surgery, University of Mississippi Medical Center, says that, "The versatility of the Integra Titan Reverse Shoulder System will allow me to custom fit the prosthesis intraoperatively to the unique anatomy of each of my patients. Additionally, it builds off the same platform-based press-fit stem as the Titan Total Shoulder, which allows for easier conversion, if ever required."

"The Reverse Shoulder System is an exciting addition to Integra's shoulder portfolio, which includes the Total Shoulder System and the Humeral Resurfacing Arthroplasty System" states Robert Paltridge, Integra's president, Extremity Reconstruction. "The patient and surgeon benefits built into our new platform-based system are a true testimony to our continued investment in advancing cost-effective technology in shoulder surgery."

The global shoulder replacement market is estimated to reach approximately $865 million in 2014 and $1.3 billion by 2017. With the addition of the Titan Reverse Shoulder System, which addresses both the press-fit and cemented reverse shoulder market, Integra is well positioned to gain a key foothold in this rapidly growing market.