Zimmer gains FDA approval for iAssist Personalized TKA Guidance system

ZIMMER’S PERSONALIZED GUIDANCE SYSTEM FOR KNEES GAINS CLEARANCE (Orthopedics This Week) Calling it “Revolutionary,” Zimmer Holdings, Inc. announced the 510(k) clearance of the iASSIST Knee, the company’s personalized guidance system for knee replacement procedures. According to a company statement on January 17, the technology comprises small electronic disposable pod components that are used at the site of knee replacement surgery, providing instantaneous, accurate alignment validation through a simple electronic display. The disposable pods are manipulated within the surgical field with positioning information provided by a series of internal accelerometers. The device does not require the use of pins or additional incisions and does not rely on external systems or stimulus. No Need for Optical-Tracking The company believes the technology is revolutionary because it is the “next step in surgical guidance, providing simple, intuitive and accurate intraoperative feedback and alignment validation to surgeons during joint replacement procedures, eliminating the need for bulky capital equipment. Current robotic and navigation systems use optical-tracking, requiring a clear line-of-sig...


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