Zimmer (NYSE:ZMH) said it won 510(k) clearance from the FDA for its iAssist Knee personalized guidance system for knee replacements.
The Warsaw, Ind.-based medical device company said the system allows surgeons to precisely position knee implants using disposable electronic "pod components" with accelerometers that relay positioning information to the physician, according to a press release.
"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," Zimmer reconstructive president Jeff McCaulley said in prepared remarks. "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."