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Exactech announced today that its BlueOrtho subsidiary has received FDA 510(k) clearance for ExactechGPS Ankle.
The Gainesville, Florida–based company described the system as the first of its kind for total ankle arthroplasty. It connects the preoperative plan with real-time intraoperative instrument guidance, confirming that resections meet the surgical plan.
Designed to improve surgical precision, the ExactechGPS Ankle combines propriety active tracker technology with a touchscreen tablet, providing dynamic feedback to surgeons during procedures.
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“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 Dr. Edward Haupt of the Mayo Clinic in Florida.
GPS Ankle has compatibility with Exactech’s flagship Vantage Total Ankle System. It will be available to hospitals and ASC centers without capital cost.
According to Exactech, bench-testing-based pre-clinical studies found an accuracy of 2 mm and 2 degrees relative to the CT-based surgical plan. This was further confirmed by two studies performed on sawbones, which were recently accepted by the Orthopaedic Research Society.
“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,” Laurent Angibaud, Exactech’s VP of development for advanced surgical technologies, added in the company’s news release.
GPS Ankle is only available in the U.S. and will enter a pilot launch with limited availability starting in 2024. The company’s GPS technology has been in use across the globe for more than a decade for shoulder and knee surgery.
Exactech develops and markets orthopaedic implant devices, related surgical instruments and the Active Intelligence platform of smart technologies.
