Warsaw, Ind.-based Zimmer Holdings Inc., a musculoskeletal health technology company, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market iAssist Knee, which the company calls a “personalized guidance system” for knee replacement procedures.
It is a surgical guidance system designed to provide improved intraoperative feedback and alignment validation to surgeons during joint replacement procedures. 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.
The system, which Zimmer officials claim will keep the operating area less cluttered, is made up of small electronic disposable pod components that are used at the site of knee replacement surgery, providing alignment validation via an 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,” said Jeff McCaulley, president of Zimmer’s reconstructive business. “This innovative technology supports more streamlined and personalized knee replacement procedures through a simple, disposable intraoperative device. 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.”
Zimmer makes orthopedic reconstructive, spinal and trauma devices, dental implants, and related surgical products.
Photo of iAssist guidance system courtesy of Zimmer Holdings Inc.