Gyder Surgical, a MedTech company specialising in intuitive, orthopaedic navigation solutions, today announced the 510(k) FDA clearance for the GYDER® Hip System, the world’s first commercially available non-invasive (pin-less) and image-less solution for the accurate positioning of the acetabular cup during Anterior Hip Arthroplasty. The FDA’s clearance decision is the second significant regulatory milestone for the GYDER® Hip System, which received Australia’s TGA regulatory approval previously. Surgical cases have already been successfully performed in Australia and India.
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Improving acetabular cup placement accuracy is clinically important with significant potential to reduce post-surgery complications, thereby improving patient outcomes and lowering health system cost burden. An estimated 700,000 hip procedures are performed annually in the United States, with growing demand driven by aging demographics and more active lifestyles. Unlike traditional hip navigation approaches, the GYDER® Hip System’s patented technology does not use invasive metallic pins. Developed by Gyder Surgical, the innovation also does not rely on pre-operative or intra-operative imaging for anatomical landmark registration. One-minute calibration and quick registration make the GYDER® Hip Navigation System a fast, easy-to-use computer-assisted navigation solution that seamlessly integrates into existing surgical workflows.
“The FDA 510(k) clearance of the GYDER® Hip System marks a significant milestone in bringing this innovation to surgeons in the world’s largest hip replacement market. The GYDER® Hip System is well suited for use in the fast-growing Ambulatory Surgery Center (outpatient) segment, with its small footprint, low training burden, speed, and efficiency. We believe the best solutions minimise complexity and do not require surgeons to change their practice significantly. And the GYDER® Hip System does exactly that.” Sujit Dike, CEO, Gyder Surgical.
