Expanded Shoulder Product Line

Integra LifeSciences Holdings Corp. officials announce that the Integra(R) Proximal Humeral Fracture Plate System received 510k clearance from the U.S. Food and Drug Administration (FDA), and expect to begin a controlled market release in 2013. It is the latest addition to Integra's growing shoulder product line and complements the Integra Titan Shoulder portfolio by offering treatment options for proximal humeral fractures.

"We are very excited to introduce our new Proximal Humeral Fracture Plate System. Not only does the system expand our shoulder product family, but the plate design also has some unique advantages, including a four screw hole option for calcar screws that allows for solid fixation in the calcar neck and provides humeral head support," states Bill Weber, Integra's vice president and general manager, Extremity Reconstruction.

The Integra Proximal Humeral Fracture Plate System offers two plate designs to address varying degrees of complex proximal humeral fractures. The two designs include a GT Plate and LP Plate in multiple anatomic left and right plate options. Both plate designs allow for varying screw diameters and lengths in locking, non-locking and lag screws options.

Approximately 108,000 shoulder fixation procedures will be performed on patients 65 years and older in the United States this year. A proximal humeral fracture is the third most common fracture reported in emergency rooms. More than 50% of all humeral fractures that are surgically treated are corrected using humeral plating systems.