Zimmer’s Knee Guidance System Cleared by FDA

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-sight into the surgical field, and rely upon complex additional equipment in the operating room, providing feedback on external computer screens.”

Jeff McCaulley, president of Zimmer’s reconstructive unit, said the “innovative” technology supports more streamlined and personalized knee replacement procedures through a “simple, disposable intraoperative device.” He added that the system “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.”

The technology is compatible with Zimmer’s current and next generation knee systems and will be on display at the upcoming annual meeting of the American Academy of Orthopaedic Surgeons in March.