Exactech, a leading developer of innovative implants, instruments, and smart technologies for joint replacement surgery, has announced that its subsidiary, BlueOrtho, has obtained FDA 510(k) clearance for the ExactechGPS® Ankle. This pioneering surgical navigation system is recognized as the world's first technology designed specifically for total ankle arthroplasty (TAA). Serving as a groundbreaking solution, GPS Ankle seamlessly integrates preoperative plans with real-time intraoperative instrument guidance, ensuring precise execution in alignment with the surgical plan. 

The system employs proprietary active tracker technology and features a compact touchscreen tablet within the sterile field, providing surgeons with dynamic intraoperative feedback throughout procedures. Compatible with Exactech's flagship Vantage® Total Ankle System, GPS Ankle will be accessible to hospitals and ASC centers without incurring capital costs. Validated through pre-clinical studies and bench testing, the system demonstrates an impressive accuracy of 2mm and 2 degrees relative to the CT-based surgical plan. This accuracy has been further corroborated by two studies conducted on sawbones, recently accepted by the Orthopaedic Research Society. 

The FDA 510(k) clearance is a significant achievement for Exactech, reinforcing the company's commitment to innovation and introduction of groundbreaking concepts in the ankle market. GPS Ankle not only represents a major stride in intraoperative guidance for ankle surgery but also highlights Exactech's dedication to continuous innovation. As part of the Active Intelligence® dynamic ecosystem, GPS Ankle joins a suite of enabling technologies and smart solutions, providing surgeons with data-rich, cost-effective tools to enhance patient outcomes. With a proven track record of over a decade in global use for shoulder and knee surgery, Exactech's GPS technology has consistently demonstrated reliability. 

Source:  businesswire.com