Gyder Surgical secures FDA 510(k) clearance for GYDER® Hip System

Gyder Surgical, a leading MedTech company focused on developing intuitive orthopedic navigation solutions, has announced that its groundbreaking GYDER® Hip System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This regulatory milestone marks a pivotal step in making the GYDER® Hip System the first commercially available non-invasive (pin-less) and image-less solution designed to enhance the accuracy of acetabular cup placement during Anterior Hip Arthroplasty. Prior to this clearance, the system had already achieved regulatory approval from Australia's Therapeutic Goods Administration (TGA), with successful surgical cases performed in both Australia and India.

Accurate positioning of the acetabular cup is critical in hip arthroplasty, as it significantly reduces the risk of post-surgery complications, thereby improving patient outcomes and reducing healthcare costs. In the United States alone, approximately 700,000 hip replacement procedures are conducted annually, with this number expected to rise due to an aging population and increasing demand from individuals maintaining active lifestyles.

What sets the GYDER® Hip System apart from traditional hip navigation technologies is its patented, non-invasive approach. Unlike conventional systems that rely on invasive metallic pins for anatomical registration, the GYDER® Hip System eliminates the need for such procedures, enhancing patient safety and comfort. Additionally, the system operates without requiring pre-operative or intra-operative imaging, streamlining the surgical process and reducing radiation exposure.

The GYDER® Hip System features a rapid one-minute calibration and quick registration process, making it an efficient and user-friendly computer-assisted navigation tool. Its design ensures seamless integration into existing surgical workflows, minimizing disruption and maintaining procedural efficiency. This efficiency, combined with its compact footprint and low training requirements, makes the GYDER® Hip System particularly well-suited for the rapidly growing Ambulatory Surgery Center (ASC) segment, where speed and operational efficiency are paramount.

“The FDA 510(k) clearance of the GYDER® Hip System is a monumental achievement, allowing us to introduce this innovative technology to surgeons in the world's largest hip replacement market,” said Sujit Dike, CEO of Gyder Surgical. “Our goal has always been to develop solutions that enhance surgical precision without adding complexity, and the GYDER® Hip System embodies this philosophy by delivering superior performance with minimal changes to existing surgical practices.”