GYDER® Hip System

The GYDER® Hip System is a computer-controlled surgical navigation system designed to assist orthopedic surgeons in positioning the acetabular cup during anterior hip arthroplasty procedures. The system uses sensors and software to determine reference alignment axes relative to anatomical structures, helping surgeons achieve accurate implant placement in patients positioned supine.

The GYDER® system uses non-invasive mechanical devices for patient registration (referencing the Anterior Pelvic Plane) rather than invasive pins used by the predicate. Both employ Inertial Measurement Units (IMU) with accelerometers and rate gyroscopes, computer-derived spatial coordinates, integrated graphical user interfaces, and DC battery power. The GYDER® system includes a sterile Clam Shell enclosure, ASIS Markers, and an Orthopaedic Brace with Impactor Set, whereas the predicate uses pelvic pins with an instrument set.

ASTM F2554-18 (consensus performance standard for angle measurement accuracy), ISO 10993-1 (2018) for biocompatibility assessment. Testing included software verification and validation, hardware verification and validation, sterilization validation, system accuracy testing via bench testing, formative and summative usability testing, and simulated use testing on cadaver models.

The GYDER® system is substantially equivalent because it performs the same intended function as the OrthAlign Plus System predicate—computer-assisted navigation for acetabular cup positioning during anterior hip arthroplasty—using equivalent measurement principles (IMU-based orientation tracking and computer-derived spatial coordinates). Although the GYDER® uses non-invasive mechanical registration rather than invasive pins, both systems achieve the same clinical outcome through comparable control mechanisms, workflows, and performance validated against the same FDA consensus standard. Testing demonstrates equivalent safety and effectiveness, with the primary clinical difference being a narrower patient population (anterior approach only, versus both anterior and posterior approaches for the predicate).