SDS Growing Rod

The SDS Growing Rod is a spinal implant system designed to correct and actively lengthen the spine in children under 10 years old with early-onset spinal deformities while allowing natural growth, eliminating the need for repeat surgeries. It uses titanium alloy springs with sliding bearings to provide distraction force for curve correction while enabling spinal growth over up to 5 years, after which it is removed or locked.

Both the SDS Growing Rod and predicate device consist of spinal rods with fixation components that maintain correction while allowing controlled growth. The primary differences are in component configuration and actuation mechanisms—the SDS uses alternative interconnections and spring-based mechanisms compared to the predicate—but these differences are implementation details that do not affect fundamental safety or effectiveness.

ASTM F1717 (spinal implant constructs in vertebrectomy model), ASTM F1798 (static and fatigue properties of interconnection mechanisms), ASTM F2624 (wear testing), and ISO 10993-1 (biological evaluation of medical devices and biocompatibility).

The SDS Growing Rod has the same intended use, similar indications, comparable technology and principles of operation, matching size parameters, and similar materials as the predicate (SHILLATM Growth Guidance System). The design differences do not negatively impact safety or effectiveness, and non-clinical and retrospective clinical data demonstrate substantially equivalent safety and effectiveness profiles.