Integra LifeSciences Gets FDA Nod For Titan Reverse Shoulder System

(RTTNews) - Medical device maker Integra LifeSciences Holdings Corp. (IART) said the Integra Titan Reverse Shoulder System has received 510k clearance from the U.S. Food and Drug Administration or FDA. Integra expects to begin a limited market release in the U.S. 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, which 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, allowing all primary, reverse, and fracture humeral bodies to be used with either the press-fit or cemented platform stems.

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

Integra would offer surgeons hands-on training on the Titan Reverse Shoulder System at the "Clinical Concepts in Shoulder Arthroplasty Course" being held at the Pacific American Life Science Learning Center on August 10, 2013 in San Diego, CA.