1. Scope

1.1 This test method specifies the materials and methods for the axial compressive subsidence testing of non-biologic intervertebral body fusion devices, spinal implants designed to promote arthrodesis at a given spinal motion segment.

1.2 This test method is intended to provide a basis for the mechanical comparison among past, present, and future non-biologic intervertebral body fusion devices. This test method allows comparison of intervertebral body fusion devices with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to mechanically compare intervertebral body fusion devices and does not purport to provide performance standards for intervertebral body fusion devices.

1.3 This test method describes a static test method by specifying a load type and a specific method of applying this load. This test is designed to allow for the comparative evaluation of intervertebral body fusion devices.

1.4 Guidelines are established for measuring test block deformation and determining the subsidence of intervertebral body fusion devices.

1.5 Units The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in terms of either degrees or radians.

1.6 Since some intervertebral body fusion devices require the use of additional implants for stabilization, the testing of these types of implants may not be in accordance with the manufacturer's recommended usage.

1.7 The use of this standard may involve the operation of potentially hazardous equipment. This standard 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 standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.

ASTM Standards

E4 Practices for Force Verification of Testing Machines

F1582 Terminology Relating to Spinal Implants

F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments

F2077 Test Methods For Intervertebral Body Fusion Devices

Keywords

intervertebral body fusion device; spinal implants; subsidence and static axial compression; Arthrodesis; Axial compression tests; Body fusion devices; Compression testing--surgical applications; Implantable surgical materials/applications; Intervertebral body fusion devices; Spinal implants; Static axial compression; Subsidence

ICS Code

ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

DOI: 10.1520/F2267-03

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