Integra LifeScience’s TITAN Reverse Shoulder get US approval

Reverse Shoulder

INTEGRA’S TITAN (REVERSE SHOULDER) LIFTS OFF (Orthopedics This Week)

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.

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