Sam Brusco, Associate Editor12.06.23
Exactech subsidiary BlueOrtho has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for ExactechGPS Ankle, which the company said is the world’s first surgical navigation system for total ankle arthroplasty (TKA).
GPS Ankle connects the preoperative plan with real-time intraoperative instrument guidance, then confirms that resections meet the surgical plan. The system’s active tracker tech and compact, touchscreen tablet in the sterile field offers surgeons 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 the company’s flagship Vantage total ankle system. Exactech said it will be available to hospitals and ambulatory surgical centers (ASCs) without a capital cost. The company also said, based on data on file, that bench tested preclinical studies showed accuracy of 2 mm and two degrees relative to the CT-based surgical plan.
This was further confirmed by two studies on sawbones, recently accepted by the Orthopaedic Research Society.1,2
“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 VP of development for advanced surgical technologies.
GPS Ankle is the latest in the company’s Active Intelligence portfolio of enabling technologies and smart solutions that provide data-rich solutions to help boost outcomes. It is expected to enter pilot launch with limited availability beginning in 2024.
References
1 Rueff M. et al. Accuracy and Precision Evaluation of Image-based Computer Assisted Surgical System for Total Ankle Arthroplasty. 2023. Accepted to ORS.
2 Rueff M. et al. Evaluation of error sources for an Image-based Computer Assisted Surgical System for Total Ankle Arthroplasty. 2023. Accepted to ORS.
GPS Ankle connects the preoperative plan with real-time intraoperative instrument guidance, then confirms that resections meet the surgical plan. The system’s active tracker tech and compact, touchscreen tablet in the sterile field offers surgeons 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 the company’s flagship Vantage total ankle system. Exactech said it will be available to hospitals and ambulatory surgical centers (ASCs) without a capital cost. The company also said, based on data on file, that bench tested preclinical studies showed accuracy of 2 mm and two degrees relative to the CT-based surgical plan.
This was further confirmed by two studies on sawbones, recently accepted by the Orthopaedic Research Society.1,2
“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 VP of development for advanced surgical technologies.
GPS Ankle is the latest in the company’s Active Intelligence portfolio of enabling technologies and smart solutions that provide data-rich solutions to help boost outcomes. It is expected to enter pilot launch with limited availability beginning in 2024.
References
1 Rueff M. et al. Accuracy and Precision Evaluation of Image-based Computer Assisted Surgical System for Total Ankle Arthroplasty. 2023. Accepted to ORS.
2 Rueff M. et al. Evaluation of error sources for an Image-based Computer Assisted Surgical System for Total Ankle Arthroplasty. 2023. Accepted to ORS.