Mechanical performance of thoracolumbosacral pedicle screw systems: An analysis of data submitted to the Food and Drug Administration.
Thoracolumbosacral pedicle screw systems (TPSSs) are spinal implants commonly utilized to stabilize the spine as an adjunct to fusion for a variety of spinal pathologies. These systems consist of components including pedicle screws, rods, hooks, and various connectors that allow the surgeon to create constructs that can be affixed to a wide range of spinal anatomy. During the development and regulatory clearance process, TPSSs are subjected to mechanical testing such as static and dynamic compression bending per ASTM F1717, axial and torsional grip testing per ASTM F1798, and foam block pullout testing per ASTM F543. In this study, design and mechanical testing data were collected from 200 premarket notification (510(k)) submissions for TPSSs submitted to FDA between 2007 and 2018. Data were aggregated for the most commonly performed mechanical tests, and analyses were conducted to assess differences in performance based on factors such as component type, dimensions, and materials of construction. Rod material had a significant impact on construct stiffness in static compression bending testing with cobalt chromium rods being significantly stiffer than titanium rods of the same diameter. Pedicle screw type had an impact on compression bending yield strength with monoaxial screws having significantly higher yield strength as compared to polyaxial or uniplanar screws. Axial and torsional gripping capacities between components and the rods were significantly lower for cross-connectors than the other component types. The aggregated data presented here can be utilized for comparative purposes to aid in the development of future TPSSs.