VerteGlide Spinal Growth Guidance System

The VerteGlide Spinal Growth Guidance System is a growing rod system designed for skeletally immature children under 10 years old with early-onset scoliosis and risk of thoracic insufficiency syndrome. It uses fusion screws at the apex to lock the rod rigidly and non-fusion sliding screws above and below to allow continued spinal growth without repeated lengthening surgeries, and is removed after skeletal maturity.

The device consists of titanium alloy (ASTM F136), unalloyed titanium (ASTM F67), or cobalt chromium (ASTM F1537) rods, screws, and connectors in multiple sizes. Differences from the predicate include variations in materials, sizes, and design features, but the submission concludes these differences do not raise new safety or effectiveness questions.

Biocompatibility per ISO 10993-1; MR safety testing per ASTM F2052, F2213, F2182, and F2119; mechanical testing per ASTM F1717, F2193, F1798, and F543; and tulip-shank dissociation and construct wear testing.

The VerteGlide has the same intended use and principle of operation as the SHILLA predicate device—both are growing rod systems for early-onset scoliosis in skeletally immature patients using fusion and non-fusion screws to allow growth. Although materials, sizes, and design details differ, mechanical testing demonstrated substantially equivalent performance, and these differences do not raise new questions of safety or effectiveness.