Zimmer Holdings, Inc. (ZMH), announced Thursday that it has received a 510(k) clearance from the U.S. Food and Drug Administration or FDA, enabling it to market iASSIST Knee, the company's personalized guidance system for knee replacement procedures.
The iASSIST Knee technology which comprises small electronic disposable pod components, provides accurate alignment validation through an electronic display, at the site of the knee replacement surgery.
The technology enables surgeons to easily perform joint replacement procedures as the iASSIST Knee technology provides accurate intraoperative feedback required for such procedures, said Zimmer in a statement.
Jeff McCaulley, President of Zimmer Reconstructive stated, "This technology supports more streamlined and personalized knee replacement procedures through a simple, disposable intraoperative device and delivers accurate implant positioning and alignment validation without the complexity, cost and time associated with current intensive navigation and robotic systems."
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