Testing Solutions for Spinal Implant Construct Testing
Spinal implants have a highly complex and variable loading due to the nonlinear force-deflection characteristics of the spine. In order to improve patient’s life during and after the surgery, development of a higher quality spinal implant is crucial.
Spinal implants are composed of many different components that are assembled to stabilize and strengthen the spine. For FDA validation, it is critical to perform testing on all components. These systems come in different shapes and sizes to accommodate different age groups. Spinal implants are categorized into two groups with different functions: fusion devices and non-fusion devices. Fusion devices are used to treat fractures and correct deformities by joining motion segments together. Certain ASTM standards specific for fusion devices have been developed such as ASTM F2077, ASTM 2267, ASTM 1798 and ASTM 2193. The second group, non-fusion devices, includes pedicle screws, hooks and rod and plate-based systems that stabilize the spine. ASTM standards developed for these systems include ASTM F1717, ASTM 2423 and ASTM F2624. These standards focus on the comparison of static and dynamic mechanical characteristics of different designs of the spinal implant components.
ADMET offers multiple mechanical force testing systems configured to meet and exceed these ASTM test standards. All of the systems are controlled with ADMET’s proven MTESTQuattro testing software that automatically performs each test according to ASTM and ISO standards, as well as custom test procedure.
Read more about spinal implant testing standards here: