1.1 This guide covers materials and methods for the static and fatigue testing of referenced thoracolumbar pedicle screw systems intended for spinal fusion. 1.2 This guide is intended to provide a summary of test methods and comparative performance values available for characterizing thoracolumbar pedicle screw system components and full systems. Equivalency with the data presented in this guide does not itself define a device that will provide adequate clinical performance. Nor does this guide preclude clinical success from devices that do not meet the specifications contained herein, should a clinically successful comparison be provided. 1.3 The guides, specifications, and test methods referred to are part of a series of standards addressing systems used in the surgical fixation of the spinal skeletal system. The user should consult Specification F2193 for methods to assess the individual components, Guide F1798 for the interconnections between individual components and subassemblies, and Test Method F1717 to evaluate an entire construct assembled. 1.4 Multiple test methods are referenced in this guide. However, the user is not necessarily obligated to test using all of the described methods. Instead, the user should only select, with justification, test methods that are appropriate for a particular device design. This may be only a subset of the herein described test methods. 1.5 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard. 1.6 This guide does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this guide to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
Keywordsfatigue test methods; spinal implant assembly; spinal implant construct; static test methods ; vertebrectomy model; bend testingrod; bend testing- screw; bend testingsurgical implants; fatigue testrod; fatigue testscrew; fatigue testsurgical implants; orthopedic medical devicerod; orthopedic medical devicescrew; orthopedic spinal devices; performance; spinal arthrodesis; surgical devices; terminology; test methodssurgical implants; thocolumbar pedicle screw system
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Draft Under Development