Exactech Announces FDA 510(k) Clearance of the World’s First Surgical Navigation for Total Ankle Replacement

06 December 2023 | Wednesday | News


Exactech, a developer and producer of innovative implants, instrumentation and smart technologies for joint replacement surgery, announced its subsidiary, BlueOrtho, has received 510(k) clearance from the Food and Drug Administration for ExactechGPS® Ankle, the world’s first surgical navigation system for total ankle arthroplasty (TAA)

GPS Ankle is a first-of-its-kind technology, which connects the preoperative plan with real-time intraoperative instrument guidance and confirms that resections meet the surgical plan. The system uses proprietary active tracker technology and a compact touchscreen tablet in the sterile field to provide surgeons with dynamic intraoperative feedback throughout their cases.

“I am already a fan of Exactech’s patient-specific instrumentation solution and am thrilled how GPS Ankle provides intraoperative flexibility at my fingertips. The ability to quantify soft tissue laxity will be a game changer for me and my patients,” said design team surgeon Edward Haupt, MD, of the Mayo Clinic in Florida.

GPS Ankle is compatible with Exactech’s flagship Vantage® Total Ankle System, and will be available to hospitals and ASC centers without capital cost. Pre-clinical studies, based on bench testing, reported an accuracy of 2mm and 2 degrees relative to the CT-based surgical plan.1 This was further confirmed by two studies performed on sawbones, which were recently accepted by the Orthopaedic Research Society. 2-3

“Exactech has introduced new concepts in the ankle market, but this clearance represents the first intraoperative guidance for ankle surgery and solidifies us as a company focused on innovation,” said Laurent Angibaud, Exactech’s vice president of development for advanced surgical technologies.

GPS Ankle is the latest product introduction of Exactech’s Active Intelligence® dynamic ecosystem of enabling technologies and smart solutions that empowers surgeons with data-rich, comparatively low-cost solutions to help improve patient outcomes. The company’s GPS technology has been in use across the globe for more than a decade for shoulder and knee surgery.

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