Integra LifeSciences Holding Corporation has received 510(k) clearance from the FDA to market the latest addition to its shoulder product line, the Proximal Humeral Fracture Plate System. The company plans a controlled release of the product during 2013.
The company release says that the Integra Proximal Humeral Fracture Plate System offers two plate designs to address varying degrees of complex proximal humeral fractures. The 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.
“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, ” said Bill Weber, Integra’s Vice President and General Manager, Extremity Reconstruction.
The company estimates that approximately 108, 000 shoulder fixation procedures will be performed on patients 65 years and older in the U.S. this year. A proximal humeral fracture is the third most common fracture reported in emergency rooms. Over half of all humeral fractures that are surgically treated are corrected using humeral plating systems.
