Orthocrat Receives 510K Clearance for TraumaCad Digital Preoperative Orthopedic Solution

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Orthocrat, Ltd. has received U.S. Federal Food and Drug Administration (FDA) 510K K042816 clearance of the sale of its newset version of TraumaCad digital orthopedic planning solutions in the U.S.

Seamlessly integrating with any PACS, TraumaCad enables surgeons to utilize digital images, tools and templates for the planning of a full range of orthopedic surgeries, providing an easier and more accurate alternative to traditional preoperative planning using hard copy film and overlays. TraumaCad displays PACS images from a full range of modalities. It enables preoperative plans to be archived with patient files and viewed in the operating room.

Featuring a complete library of implants and fixation element templates from most leading manufacturers, TraumaCad streamlines comparison of templates with digital patient images to allow selection of the best surgical option. TraumaCad automatically displays implants to scale with patient anatomical images. Using a simple wizard-like process, surgeons are guided through all pre-surgical planning steps.

"We see this as an important step in further positioning our company in the market, as well as a validation for our product and for our development strategy. It is a part of our goal to offer a comprehensive, affordable orthopedic planning package to the U.S. and worldwide market, “said Miron Liram, President, CTO and a founder of Orthocrat Ltd.

By improving planning accuracy and workflow and eliminating film, TraumaCad enables a range of clinical benefits including precise, reproducible measurements of implants. Using the advanced software, surgeons can enter the operating room equipped with the specific tools, instruments and implants they need, shortening procedure time.

Scaleable and Web-based, TraumaCad turns any PC into a full-featured diagnostic workstation, delivering affordable enterprise-wide access to images and surgical plans. It is compatible with CR, DR, CT, MRI modalities. Among the supported implant manufacturers are Biomet, Depuy, Smith and Nephew, Stryker, Wright and Zimmer.

About Orthocrat

Orthocrat was established in early 2003 by a team of experienced surgeons, with the goal of developing practical computer assisted surgical techniques. TraumaCad was Orthocrat’s first introduction in a growing product line and enables pre-surgical planning of trauma, arthroplasty and osteotomy procedures. Orthocrat products are equally suited for small- to medium-size practices as well as for larger academic institutions.

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Visit their website at http://www.ortho-cad.com

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Zeev Glozman