CORRECTING and REPLACING OrthoHelix(TM) Surgical Design, Inc. Receives Clearance from FDA for Calcaneal Trauma System

Please do not use the photo that accompanied the release dated July 17, 2006. The news content of the release is unchanged.

The release reads:


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.

"The anatomically contoured design of the plate reduces the problem of hardware impingement on the peroneal tendons and allows more rigid fixation where you need it, at the posterior facet," stated Dr. Bryan Den Hartog of Black Hills Surgery Center in Rapid City, South Dakota.

OrthoHelix Surgical Designs, Inc. is an early stage medical device company developing a comprehensive line of implants and instruments for use in hand and foot reconstructive surgery. Our mission is to develop and deliver innovative orthopedic implants and instruments that elevate the art of small bone surgery. Our executive team brings over 70 years of successful orthopedic industry experience and is backed by an elite Medical Advisory Board whose membership consist of the nations top surgeons practicing in the hand/wrist, foot/ankle and podiatry surgery. "Surgeons Speak. We DELIVER."(TM)

The OrthoHelix product line is based on a portfolio of patent and patent pending designs that will offer the most complete and innovative line of specialized implants and instruments.

For more information please contact OrthoHelix(TM) at 1-866-90 HELIX or email; .

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