Exactech subsidiary BlueOrtho has obtained the US Food and Drug Administration (FDA) 510(k) clearance for its surgical navigation system, GPS Ankle, intended for total ankle arthroplasty (TAA).
The GPS Ankle is the latest addition to Exactech’s Active Intelligence lineup, featuring advanced technologies and smart solutions.
Claimed to be the first-of-its-kind technology worldwide, GPS Ankle connects the preoperative plan with real-time intraoperative instrument guidance, ensuring that resections align with the surgical plan.
Using active tracker technology and a compact touchscreen tablet in the sterile field, it offers dynamic intraoperative feedback to surgeons throughout their cases.
Designed to be available to hospitals without capital cost, the system is compatible with the company’s Vantage Total Ankle System.
Pre-clinical tests conducted through bench testing showed an accuracy of 2mm and 2° when compared to the CT-based surgical plan.
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Two studies on sawbones, accepted by the Orthopaedic Research Society, further validate these findings.
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.”
The GPS Ankle will only be introduced in the US and undergo a pilot launch with limited availability starting next year.
Exactech distributes GPS, Equinoxe Planning App and Predict+ developed by BlueOrtho.
In September, Exactech received 10(k) clearance from the FDA for its Activit-E polyethylene for the VantageTotal Ankle System.
An advanced crosslinked polyethylene with vitamin E antioxidant stabilisation, Activit-E utilises a unique manufacturing process for the replacement of gamma irradiation crosslinking with peroxide crosslinking.
