US-based medical device company Exactech, through its subsidiary BlueOrtho, has received the US Food and Drug Administration (FDA) 510(k) approval for its GPS Ankle device.

GPS Ankle is an advanced technology that connects preoperative planning with real-time intraoperative instrument guidance to ensure resections meet the surgical plan.

The system leverages unique active tracker technology and a compact touchscreen tablet in the sterile field to provide surgeons with dynamic intraoperative feedback.

It is also the world’s first surgical navigation system for total ankle arthroplasty (TAA), claims the US-based medical device company.

Exactech advanced surgical technologies development vice president Laurent Angibaud said: “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.”

Mayo Clinic in Florida design team surgeon Edward Haupt said: “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.”

Exactech said its GPS Ankle is the latest addition to its Active Intelligence dynamic ecosystem of technologies and smart solutions.

It is compatible with the company’s Vantage Total Ankle System and will be offered to hospitals and ASC centres without additional capital costs.

Also, its GPS technology has been used for shoulder and knee surgery across the world, for more than a decade, said the medical device maker.

In the pre-clinical studies conducted based on bench testing, GPS Ankle showed an accuracy of 2mm and two degrees relative to the CT-based surgical plan.

The pre-clinical study results were further confirmed by two studies performed on sawbones, which were recently accepted by the Orthopaedic Research Society.

Exactech is planning to commercialise the GPS Ankle device only in the US, with a limited release starting in 2024.