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Spinal Devices

ASTM is one of the leading standards developers for medical devices. With 24 categories, addressing everything from surgical implements to automated analysis, ASTM medical device standards cover a truly wide range. With how much research and training goes into the medical industry, standardization plays a key role in productively actualizing that effort. Organized below for your convenience by usage, industry, and theme are over 300 standards. This list includes standards related to Spinal Devices.

ASTM F1717-21

Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model

1.1 These test methods cover the materials and methods for the static and fatigue testing of spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of spinal implant components can be specific, depending on the intended spinal location and intended method of application to the spine. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future spinal implant assemblies. They allow comparison of spinal implant constructs with different intended spinal locations and methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device. 1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and one fatigue test are defined for the comparative evaluation of spinal implant assemblies. 1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of the spinal implant assembly. 1.5 Some spinal constructs may not be testable in all test configurations. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2789-10(2020)

Standard Guide for Mechanical and Functional Characterization of Nucleus Devices

1.1 This guide describes various forms of nucleus replacement and nucleus augmentation devices. It further outlines the types of testing that are recommended in evaluating the performance of these devices. 1.2 Biocompatibility of the materials used in a nucleus replacement device is not addressed in this guide. However, users should investigate the biocompatibility of their device separately (see X1.1 ). 1.3 While it is understood that expulsion and endplate fractures represent documented clinical failures, this guide does not specifically address them, although some of the factors that relate to expulsion have been included (see X1.3 ). 1.4 Multiple tests are described in this guide; however, the user need not use them all. It is the responsibility of the user of this guide to determine which tests are appropriate for the devices being tested and their potential application. Some tests may not be applicable for all types of devices. Moreover, some nucleus devices may not be stable in all test configurations. However, this does not necessarily mean that the test methods described are unsuitable. 1.5 The science of nucleus device design is still very young and includes technology that is changing more quickly than this guide can be modified. Therefore, the user must carefully consider the applicability of this guide to the user s particular device; the guide may not be appropriate for every device. For example, at the time of publication, this guide does not address the nucleus replacement and nucleus augmentation devices that are designed to be partially or completely resorbable in the body. However, some of the test recommended in this guide may be applicable to evaluate such devices. It has not been demonstrated that mechanical failure of nucleus devices is related to adverse clinical results. Therefore this standard should be used with care in evaluating proposed nucleus devices. 1.6 This guide is not intended to be a performance standard. It is the responsibility of the user of this guide to characterize the safety and effectiveness of the nucleus device under evaluation. 1.7 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. Angular measurements may be reported in either degrees or radians. 1.8 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2077-18

Test Methods For Intervertebral Body Fusion Devices

1.1 This test method covers the materials and methods for the static and dynamic testing of intervertebral body fusion device assemblies, 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 nonbiologic intervertebral body fusion device assemblies. This test method allows comparison of intervertebral body fusion device assemblies with different intended spinal locations and methods of application to the intradiscal spaces. This test method is intended to enable the user to compare intervertebral body fusion device assemblies mechanically and does not purport to provide performance standards for intervertebral body fusion device assemblies. 1.3 The test method describes static and dynamic tests by specifying force types and specific methods of applying these forces. These tests are designed to allow for the comparative evaluation of intervertebral body fusion device assemblies. 1.4 These tests are designed to characterize the structural integrity of the device and are not intended to test the bone-implant interface. 1.5 This test method does not address expulsion testing of intervertebral body fusion device assemblies (see 1.4 ). 1.6 Guidelines are established for measuring displacements, determining the yield force or moment, evaluating the stiffness, and strength of the intervertebral body fusion device assemblies. 1.7 Some intervertebral body fusion device assemblies may not be testable in all test configurations. 1.8 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians. 1.9 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.10 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2193-20

Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

1.1 These specifications and test methods are intended to provide a comprehensive reference for the components of systems used in the surgical fixation of the spinal skeletal system. The document catalogs standard specifications that specify material, labeling, and handling requirements. The specifications and test methods also establish common terminology that can be used to describe the size and other physical characteristics of spinal components and performance definitions related to the performance of spinal components. Additionally, the specifications and test methods establish performance requirements and standard test methods to consistently measure performance-related mechanical characteristics of spinal components. 1.2 These specifications and test methods are part of a series of standards addressing systems used in the surgical fixation of the spinal skeletal system. These specifications and test methods concentrate on the individual components, which are found in many spinal fixation systems. If the user is interested in evaluating the next level in the spinal fixation system chain, the interconnections between individual components and subassemblies (two or more components), the user should consult Guide F1798 . At the highest level in this chain is Test Methods F1717 , which is used to evaluate an entire construct assembled from many components and involves numerous interconnections and several subassemblies. 1.3 It is not the intention of these specifications and test methods to define levels of performance or case-specific clinical performance for spinal components addressed by this document. Insufficient knowledge to predict the consequences of using any of these components in individual patients for specific activities of daily living is available. Furthermore, it is not the intention of this document to describe or specify specific designs for the individual components of systems used in the surgical internal fixation of the spinal skeletal system. 1.4 These specifications and test methods may not be appropriate for all types of spinal surgical fixation systems. The user is cautioned to consider the appropriateness of this document in view of the particular implant system and its potential application. 1.5 This document includes the following specifications and test methods that are used in determining the spinal component's mechanical performance characteristics: 1.5.1 Specification for Metallic Spinal Screws Annex A1 . 1.5.2 Specification for Metallic Spinal Plates Annex A2 . 1.5.3 Specification for Metallic Spinal Rods Annex A3 . 1.5.4 Test Method for Measuring the Static and Fatigue Bending Strength of Metallic Spinal Screws Annex A4 . 1.6 Unless otherwise indicated, the values stated in SI units shall be regarded as the standard. 1.7 This standard may involve hazardous materials, operations, and 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2706-18

Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model

1.1 These test methods cover the materials and methods for the static and fatigue testing of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies in a vertebrectomy model. The test materials for most combinations of occipital-cervical and occipital-cervical-thoracic spinal implant components can be specific depending on the intended location and intended method of attachment. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future occipital-cervical and occipital-cervical-thoracic spinal implant assemblies. They allow comparison of occipital-cervical and occipital-cervical-thoracic spinal implant constructs with different methods of application to the spine. These test methods are not intended to define levels of performance, since sufficient knowledge is not available to predict the consequences of the use of a particular device. 1.3 These test methods set out guidelines for load types and methods of applying loads. Methods for three static load types and two fatigue tests for the comparative evaluation of occipital-cervical and occipital-cervical-thoracic spinal implant assemblies are defined. 1.4 These test methods establish guidelines for measuring displacements, determining the yield load, and evaluating the stiffness and strength of occipital-cervical or occipital-cervical-thoracic spinal implant assemblies. 1.5 It may not be possible to test some occipital-cervical and some occipital-cervical-thoracic spinal constructs in all test configurations. 1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2790-10(2019)e1

Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses

1.1 This practice provides guidance for the static and dynamic testing of Lumbar Total Facet Prostheses (FPs). These implants are intended to allow motion and lend support to one or more functional spinal unit(s) through replacement of the natural facets. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic FPs. These test methods allow comparison of devices with different methods of application to the lumbar spine. These test methods are intended to enable the user to mechanically compare devices and do not purport to provide performance standards for them. 1.3 These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads. 1.4 These test methods do not purport to address all clinically relevant failure modes for FPs, some of which will be device-specific. For example, these test methods do not address implant wear resistance under expected in vivo loads and motions. In addition, the biologic response to wear debris is not addressed in these test methods. 1.5 Requirements are established for measuring displacements and evaluating the stiffness of an FP. 1.6 Some devices may not be testable in all test configurations. 1.7 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. 1.8 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F1798-21

Standard Test Method for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants

1.1 This test method covers the measurement of uniaxial static and fatigue strength, and resistance to loosening of the component interconnection mechanisms of spinal arthrodesis implants. 1.2 The purpose of this test method is to provide a means of mechanically characterizing different designs of spinal implant interconnections. Ultimately, the various components and interconnections should be combined for static and fatigue testing of the spinal implant construct. It is not the intention of this test method to address the analysis of spinal implant constructs or subconstructs or to define levels of performance of spinal implants, as insufficient knowledge is available to predict the consequences of the use of particular spinal implant designs. 1.3 This standard defines test methods to measure the strength of spinal implant component interconnections and how to report test results. 1.4 The values stated in SI units are to be regarded as standard, with the exception of angular measurements, which may be reported in terms of either degrees or radians. 1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2694-16(2020)

Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses

1.1 This practice provides guidance for the functional, kinematic, and wear testing of motion-preserving total facet prostheses for the lumbar spine. These implants are intended to allow motion and lend support to the functional spinal unit(s) through replacement of the natural facets. 1.2 This practice is not intended to address the bone implant interface or the static characteristics of the prosthesis components. Fatigue characteristics are included, but only as a by-product of cyclic wear testing under facet load and thus are not addressed in the typical process of generating a Stress-Life (S-N) characterization. 1.3 Biocompatibility of the materials used in a total facet prosthesis are not addressed in this practice. 1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4.1 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in either degrees or radians. 1.5 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.6 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2624-12(2020)

Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs

1.1 This test method describes methods to assess the static and dynamic properties of single level spinal constructs. 1.2 An option for assessing wear using a weight loss method and a dimensional analysis is given. This method, described herein, is used for the analysis of devices intended for motion preservation, using testing medium as defined in this standard ( 6.1 ). 1.3 This test method is not intended to address any potential failure mode as it relates to the fixation of the device to its bony interfaces. 1.4 It is the intent of this test method to enable single level extra-discal spinal constructs with regard to kinematic, functional, and wear characteristics when tested under the specified conditions. 1.5 This test method is not intended to address facet arthroplasty devices. 1.6 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures be established. This test method is intended to facilitate uniform testing methods and data reporting. 1.7 The motion profiles specified by this test method do not necessarily accurately reproduce those occurring in vivo . Rather this method provides useful boundary/endpoint conditions for evaluating implant designs in a functional manner. 1.8 This test method is not intended to be a performance standard. It is the responsibility of the user of this test method to characterize the safety and effectiveness of the device under evaluation. 1.9 Multiple test methods are included in this standard. However, it must be noted that the user is not obligated to test using all of the described methods. Instead, the user should only select test methods that are appropriate for a particular device design. In most instances, only a subset of the herein described test methods will be required. 1.10 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in either degrees or radians. No other units of measurement are included in this standard. 1.11 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.12 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F1582-98(2016)

Standard Terminology Relating to Spinal Implants

1.1 This terminology covers basic terms and considerations for spinal implant devices and their mechanical analyses.

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ASTM F2267-04(2018)

Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression

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 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 method 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 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. 1.6 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. 1.7 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2346-18

Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs

1.1 These test methods specify the materials and methods for the static and dynamic testing of artificial intervertebral discs. 1.2 These test methods are intended to provide a basis for the mechanical comparison among past, present, and future non-biologic artificial intervertebral discs. These test methods allow comparison of artificial intervertebral discs with different intended spinal locations (cervical, thoracic, and lumbar) and methods of application to the intervertebral spaces. These test methods are intended to enable the user to mechanically compare artificial intervertebral discs and do not purport to provide performance standards for artificial intervertebral discs. 1.3 These test methods describe static and dynamic tests by specifying load types and specific methods of applying these loads. These tests are designed to allow for the comparative evaluation of artificial intervertebral discs. 1.4 These test methods do not purport to address all clinically relevant failure modes for artificial intervertebral discs, some of which will be device specific. For example, these test methods do not address the implant's resistance to expulsion or implant wear resistance under expected in vivo loads and motions. In addition, the biologic response to wear debris is not addressed in these test methods. 1.5 Requirements are established for measuring displacements, determining the yield load or moment, and evaluating the stiffness of artificial intervertebral discs. 1.6 Some artificial intervertebral discs may not be testable in all test configurations. 1.7 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. 1.8 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.9 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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ASTM F2423-11(2020)

Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses

1.1 This guide provides guidance for wear and/or fatigue testing of total disc prostheses under functional and kinematic conditions and, to this end, describes test methods for assessment of the wear or functional characteristics, or both, of total disc prostheses. 1.2 Both lumbar and cervical prostheses are addressed. 1.3 Load and kinematic profiles for lumbar and cervical devices are not identical and, therefore, are addressed separately in the guide. 1.4 Partial disc replacements, such as nucleus replacements or facet joint replacements, are not intended to be addressed. 1.5 Wear is assessed using a weight loss method in a testing medium as defined in this guide. 1.6 This guide does not address any potential failure mode as it relates to the fixation of the implant to its bony interfaces. 1.7 It is the intent of this guide to enable comparison of intervertebral disc (IVD) prostheses with regard to wear and fatigue characteristics when tested under the specified conditions. It must be recognized, however, that there are many possible variations in in-vivo conditions. A single laboratory simulation with a fixed set of parameters might not be universally representative. 1.8 Most IVD prostheses primarily fall into two classifications: articulating ball-in-socket type prostheses, and elastomeric or compliant type prostheses. For the former, this guide primarily addresses Mode 1 wear (defined in 3.2.17.1 ); whereas for the latter, this guide addresses potential failure of the prosthesis when the implant is subjected to a range of motion and/or loads that fall within the full range of possible physiologic motions and loads. 1.9 For articulating components, this guide predominantly describes a Mode 1 test. The user is cautioned that other modes of wear may occur and may have significant influence on the functionality and performance of an articulating IVD prosthesis; therefore, the user should consider the effects of other wear modes on the performance of the prosthesis. 1.10 In order that the data be reproducible and comparable within and between laboratories, it is essential that uniform procedures are established. This guide is intended to facilitate uniform methods for testing and reporting of data for total disc replacement prostheses. 1.11 Without a substantial clinical retrieval history of IVD prostheses, actual loading profiles and patterns cannot be delineated at the time of the writing of this guide. It therefore follows that the load and motion conditions specified by this guide do not necessarily accurately reproduce those occurring in vivo . Rather, this guide provides useful boundary/endpoint conditions for evaluating prosthesis designs in a functional manner. 1.12 The values stated in SI units are to be regarded as the standard with the exception of angular measurements, which may be reported in either degrees or radians. 1.13 This guide is not intended to be a performance standard. It is the responsibility of the user of this guide to characterize the safety and effectiveness of the prosthesis under evaluation. 1.14 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.15 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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