The folks at Integra LifeSciences Holding Corporation are celebrating. The FDA has granted a 510(k) clearance for its Titan Reverse Shoulder System. The company plans to begin a limited market release of the system in the U.S. in the third quarter of 2013 and, upon CE Mark clearance in Europe, initiate a full global commercial launch.
Integra officials explain that the Reverse Shoulder System is built on a 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.
Analysts anticipate that the global shoulder replacement market will reach nearly $865 million in 2014 and $1.3 billion by 2017. With the addition of the Titan Reverse Shoulder System that addresses both the press-fit and cemented reverse shoulder market, Integra believes that it is well positioned to gain a key foothold in this rapidly growing market.