510(k) for iASSIST Guidance Technology

Zimmer Holdings Inc. received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market iASSIST Knee, the Personalized Guidance System for knee replacement procedures.

iASSIST represents a revolutionary 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.

Watch a video demonstration on how the system functions.

Zimmer's iASSIST Knee 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.  iASSIST Knee does not require the use of pins or additional incisions and does not rely on external systems or stimulus. 

"iASSIST Knee represents the next-step in intelligent instruments, offering significant benefits to patients, health care providers and health systems. This innovative technology supports more streamlined and personalized knee replacement procedures through a simple, disposable intraoperative device," says Jeff McCaulley, president, Zimmer Reconstructive.  "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." 

iASSIST Knee technology is compatible with Zimmer's current and next generation knee systems.