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Zimmer receives 510(k) clearance for knee replacement system
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Zimmer Holdings, Inc. announced that it has received 510(k) clearance from the FDA for iAssist Knee, a personalized guidance system for knee replacement procedures.
According to a press release, the iAssist provides intraoperative feedback and alignment validation to surgeons during joint replacement procedures. Comprised of small electronic disposable pod components that are used at the site of knee replacement surgery, the iAssist does not require the use of pins or additional incisions and does not rely on external systems or stimulus.
The disposable pods are manipulated within the surgical field with positioning information provided by a series of internal accelerometers. The system also provides alignment validation through a simple electronic display.
“iAssist Knee represents the next step in intelligent instruments, offering significant benefits to patient, health care providers and health systems. This innovative technology supports more streamlined and personalized knee replacement procedures through a simple, disposable intraoperative device,” Jeff McCaulley, president of Zimmer Reconstructive, stated in a press release. “We are greatly excited by the potential of iAssist technology, which delivers on the promise of accurate implant positioning and alignment validation without the complexity, cost and time associated with current capital-intensive navigation and robotic systems.”