CUREXO Technology Corporation Announces 510(k) Submission To FDA For Total Knee Arthroplasty Application

Main Category: Bones / Orthopedics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 26 Feb 2009 - 1:00 PDT

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CUREXO Technology Corporation, pioneer in medical robotics and world leader in image-directed robotic products for orthopaedic applications, which is focused on marketing its robotic system, announced that it has submitted a premarket notification 510(k) application to the U.S. Food and Drug Administration (FDA) for market clearance in the U.S. for use of its ROBODOC(R) Surgical System for Total Knee Arthroplasty (TKA).

The 510(k) application is used when there exist similar, previously-cleared technologies in the marketplace. This submission follows the company's recently cleared 510(k) for Total Hip Arthroplasty (THA) and will offer surgeons an accurate, precise, and reproducible surgical technique to prepare the joint during a knee replacement procedure. The process will allow surgeons to preoperatively plan their surgery in a 3-D virtual space and then execute the surgery exactly as planned in the operating theatre.

"We are very pleased to announce the submission of the TKA 510(k) application to the FDA, as it demonstrates that we are moving forward with achieving our goals of providing a world class multi-platform technology," said Brent D. Mittelstadt, President and CEO of CUREXO Technology Corporation. "We believe that because of our recent hip application clearance, receiving the TKA market clearance should be granted within a reasonable time frame. Offering this additional application will allow us to build upon relationships that we are establishing as we introduce the ROBODOC(R) Surgical System into the U.S. orthopaedic community," continued Mr. Mittelstadt.

About CUREXO Technology Corporation

CUREXO Technology Corporation develops, manufactures, and markets an image directed surgical robotic system for orthopaedic surgery. The ROBODOC(R) Surgical System includes two components; ORTHODOC(R), a computer workstation equipped with proprietary software for 3-D preoperative surgical planning, and the ROBODOC(R) Surgical Assistant, a computer-controlled surgical robot utilized for precise cavity and surface preparation for hip and knee replacement surgeries.

The ROBODOC(R) Surgical System has been cleared by the U.S. FDA for Total Hip Arthroplasty procedures; making it the only active robotic system cleared by the FDA for orthopaedic surgery. To date the system has been used in over 24,000 surgical procedures worldwide.

ROBODOC(R) and ORTHODOC(R) are registered trademarks of CUREXO Technology Corporation. For more information, visit http://www.robodoc.com.

CUREXO Technology Corporation
http://www.robodoc.com

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