FDA approves the iASSIST Knee (Zimmer) for Knee Replacement surgery

The FDA has given 510(k) clearance to the iASSIST Knee, from Zimmer, which is a personalized guidance system for Knee Replacement procedures. 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. iASSIST Knee does not require the use of pins or additional incisions and does not rely on external systems or stimulus. This system provides simple, intuitive and accurate intraoperative feedback and alignment validation to surgeons during joint replacement procedures.