In a poignant LinkedIn post that has resonated across the orthopedic community, Robert Clayton, President of the British Orthopaedic Foot and Ankle Society, shared a bittersweet milestone: he implanted what is believed to be the last Scandinavian Total Ankle Replacement (STAR) in the United Kingdom.Developed in the 1970s by Hakon Kofoed and refined over decades, the STAR ankle prosthesis boasts the longest-standing survivorship data of any current ankle implant, with excellent long-term outcomes backed by years of real-world evidence.
Yet, it's being withdrawn—not because it fails patients, but because the EU Medical Device Regulation (MDR) has made it economically unviable for manufacturers to maintain certification for lower-volume, niche products like this one.
Clayton pulls no punches: "The costs are so high it is now uneconomic to sell such implants, no matter how effective they are." He warns that this issue extends far beyond ankle replacements, threatening treatments across healthcare. Without political intervention, we'll see fewer options, stifled innovation, and rising oligopoly power among the few large manufacturers who can afford the regulatory burden.The comments on...
