Exactech received FDA Clearance for its First-of-its-Kind Surgical Navigation for Total Ankle Replacement

Exactech, a developer and manufacturer of cutting-edge implants, surgical instruments, and intelligent technologies for joint replacement procedures, recently announced that its subsidiary, BlueOrtho, has obtained 510(k) clearance from the Food and Drug Administration for ExactechGPS® Ankle. This groundbreaking surgical navigation system is the first of its kind for total ankle arthroplasty (TAA).

The GPS Ankle system connects preoperative plans with real-time intraoperative instrument guidance, ensuring that surgical resections align with the planned procedure. It employs proprietary active tracker technology and a compact touchscreen tablet in the sterile field, providing surgeons with dynamic intraoperative feedback.

This marks a significant leap for Exactech in the ankle surgery market, as they introduce innovative concepts and secure the first-ever intraoperative guidance for ankle surgery. GPS Ankle is the latest addition to Exactech's Active Intelligence® dynamic ecosystem, offering surgeons data-rich and cost-effective solutions to enhance patient outcomes.

The company has a decade-long global track record of using GPS technology in shoulder and knee surgery, and this clearance solidifies their dedication to innovation in joint replacement surgery, particularly in the realm of ankle arthroplasty.



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