The FDA clearance of the ROBODOC system
Even though the Integrated Surgical Systems Inc. developed the Robodoc and sold app. 50 units in Europe and Asia, due to the continuing liquidity problems it could not live long enough to vitnes the FDA approval of the robot. (See previous post.)
The ROBODOC, a Curexo Tech, Inc. was founded in 2002 to marketize and profit from the Robodoc system. In August 2008 the system finally received a 510(k) clearance from FDA.
This 510(k) FDA clearance is an important milestone because it opens up doors to other manufacturers of similar (automated) robotic surgery systems. The process of applying for FDA clearance is easier for other robotic systems if they can prove that they are sufficiently similar to an existing product (i.e., ROBODOC).
"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.
This system includes two components; ORTHODOC®, a computer workstation equipped with proprietary software for 3-D preoperative surgical planning, and the ROBODOC® 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).
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."
Update: TV coverage of the approval, and the press conference (video) about it.
Update2: ROBODOC starts to sell large in Japan