OrthoHelix(TM) Surgical Design, Inc. Receives Clearance From FDA For Calcaneal Trauma System

AKRON, Ohio--(BUSINESS WIRE)--July 18, 2006-- OrthoHelix Surgical Design, Inc. received 510k clearance from the Food and Drug Administration on the Calcaneal Trauma System. The Calcaneal Trauma System is a set of titanium, implantable, bone fixation plates and screws. Its intended use is to stabilize and aid in the fixation of fractures of the calcaneus. The system includes four fixation plates and an assortment of locking and non-locking screws. The plates are offered in two different sizes; standard and large in both left and right versions. The plates are fully contoured so it offers a better fit with the lateral surface of the calcaneus and allows for multi-planar fixation. This unique plate design was modeled from a proprietary software system and human bone, allowing for a significantly stronger construction than those plates currently on the market.
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