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ROBODOC(R) announced today that, under the name of its predecessor, it received 510(k) clearance from the FDA for its DigiMatch(TM) ROBODOC(R) Surgical System.

ROBODOC(R), a CUREXO Technology Company, the pioneer in medical robotics and world leader in image-directed robotic products for orthopaedic applications, announced today 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 US 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 US FDA.