Gyder Surgical has garnered U.S. Food and Drug Administration 510(k) clearance for the GYDER Hip System, touted as the world’s first commercially available non-invasive (pinless), image-less solution for accurate acetabular cup positioning during anterior hip arthroplasty.

The FDA clearance decision is the second significant regulatory milestone for the GYDER Hip System, as the product has previously won Australia’s TGA regulatory approval. Surgical cases have already been successfully performed in Australia and India.

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 minimize complexity and do not require surgeons to change their practice significantly. The GYDER Hip System does exactly that,” Gyder Surgical CEO Sujit Dike said.

Gyder Surgical specializes in intuitive, orthopedic navigation products. Its first product, the GYDER Hip Navigation System, is designed to help surgeons accurately place the acetabular cup during anterior hip replacement surgery. Gyder Surgical is a member of the 2024 Medtech Innovator Asia Pacific cohort.