DigiMatch(TM) ROBODOC(R) Surgical System Receives U.S. FDA 510(k) Marketing Clearance

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals;  IT / Internet / E-mail
Article Date: 14 Aug 2008 - 1:00 PDT

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ROBODOC(R), a CUREXO Technology Company, the pioneer in medical robotics and world leader in image-directed robotic products for orthopaedic applications, announced that under the name of its predecessor, Integrated Surgical Systems, Inc., it received 510(k) clearance from the United States Food and Drug Administration (FDA) for its DigiMatch(TM) ROBODOC(R) Surgical System.

The newly cleared system delivers a precise, repeatable surgical technique to prepare the joint for hip replacement procedures. The process allows the surgeon to select an ideal implant from multiple implant manufacturers after reviewing a detailed CT scan of the patient's joint. Utilizing the proprietary system software, surgeons for the first time can now preview the surgical outcome before beginning the actual operation.

The robotic assistant has been used in over 24,000 joint replacement procedures worldwide and is shown to be less traumatic for patients and more precise than manual preparation techniques. In Total Hip surgery applications the ROBODOC System executes exact bone cutting and precise implant placement to reduce surgical fractures and complications and minimize human error.

"We are very pleased to receive FDA clearance for the ROBODOC System. This milestone represents the first active robotic system cleared by the FDA for orthopaedic surgery allowing our advanced technology to be marketed in US, the largest market in the world for medical devices," commented Dr. Ramesh Trivedi, President and CEO of ROBODOC. "We will continue our efforts to further penetrate existing markets where we have met the local regulatory requirements. At the same time we are building an infrastructure to introduce the ROBODOC system to U.S. orthopaedic surgeons, hospitals, and patients."

In 2007, Integrated Surgical Systems with the approval of its shareholders transferred all of its assets to Curexo, Inc. Since the formal clinical studies were started prior to the asset transfer, 510(k) clearance has been received under the name of Integrated Surgical Systems. ROBODOC, a CUREXO Technology Company is making appropriate changes in the registration of the device with U.S. FDA.

About ROBODOC

ROBODOC(R), a CUREXO Technology Company, develops, manufactures, and markets an image directed surgical robotic system for orthopaedic surgery. This 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 System, previously marketed by Integrated Surgical Systems (ISS), made medical history in 1992 as the first robot assisting in a human Total Hip Arthroplasty (THA).

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

ROBODOC
http://www.robodoc.com