The US Food and Drug administration (FDA) has granted 510(k) and limited launch approval to Wright Medical's Prophecy Inbone Pre-Operative Navigation Alignment Guides for total ankle replacement.
The Prophecy Inbone, which utilizes computed tomography (CT) scans to create patient-specific ankle alignment guides, is designed to facilitate the surgeons’ ability to precisely size, place and align the company’s Inbone Total Ankle Replacement components during surgery.
The company said full US commercial release is expected to take place in the second half of 2012.
Orthopedic Foot & Ankle Center surgeon Gregory Berlet said the Prophecy Inbone enable them to accurately position the Inbone Total Ankle Replacement components while providing predictable implant alignment from case to case.
Wright Medical president and CEO Robert Palmisano said with this new addition to their foot and ankle products, surgeons now have a visual plan that details implant placement in advance of the actual surgery, which can reduce the amount of standard instrumentation required in the operating room and streamline the surgical procedure.