ASTM F2423-11

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

SIGNIFICANCE AND USE
This guide can be used to determine the fatigue and wear behavior of IVD prostheses subjected to functional and kinematic cyclic loading/motion for relatively large numbers of cycles (for example, various designs of IVD prostheses, as well as the effects of materials, manufacturing techniques and other design variables on one particular design can be determined using this guide).
This guide is intended to be applicable to IVD prostheses that support load and transmit motion by means of an articulating joint or by use of compliant materials. Ceramics, metals, or polymers, or combination thereof, are used in IVD prosthesis, and it is the goal of this guide to enable a kinematic wear and/or fatigue comparison of these devices, regardless of material and type of device.
SCOPE
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 the 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 herein); 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, and 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,...

General Information

• Status: Historical
• Publication Date: 30-Jun-2011
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.25 - Spinal Devices

Relations

• Replaces: ASTM F2423-05 - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
• Effective Date: 01-Jul-2011
• Referred By: ASTM F3295-18 - Standard Guide for Impingement Testing of Total Disc Prostheses
• Effective Date: 01-Jul-2011
• Referred By: ASTM F2759-19 - Standard Guide for Assessment of the Ultra-High Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic and Spinal Devices
• Effective Date: 01-Jul-2011
• Referred By: ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
• Effective Date: 01-Jul-2011
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 01-Jul-2011
• Referred By: ASTM F2624-12(2020) - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• Effective Date: 01-Jul-2011
• Referred By: ASTM F2694-16(2020) - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
• Effective Date: 01-Jul-2011

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F2423 − 11
Standard Guide for
Functional, Kinematic, and Wear Assessment of Total Disc
1
Prostheses
This standard is issued under the fixed designation F2423; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope of wear may occur and may have significant influence on the
functionality and performance of an articulating IVD
1.1 This guide provides guidance for wear and/or fatigue
prosthesis,andthereforetheusershouldconsidertheeffectsof
testing of total disc prostheses under functional and kinematic
other wear modes on the performance of the prosthesis.
conditions and, to this end, describes test methods for assess-
ment of the wear or functional characteristics, or both, of total 1.10 In order that the data be reproducible and comparable
disc prostheses. within and between laboratories, it is essential that uniform
procedures are established. This guide is intended to facilitate
1.2 Both lumbar and cervical prostheses are addressed.
uniformmethodsfortestingandreportingofdatafortotaldisc
1.3 Load and kinematic profiles for lumbar and cervical
replacement prostheses.
devices are not identical and, therefore, are addressed sepa-
1.11 Without a substantial clinical retrieval history of IVD
rately in the guide.
prostheses, actual loading profiles and patterns cannot be
1.4 Partial disc replacements, such as nucleus replacements
delineated at the time of the writing of this guide. It therefore
or facet joint replacements, are not intended to be addressed.
follows that the load and motion conditions specified by this
guide do not necessarily accurately reproduce those occurring
1.5 Wearisassessedusingaweightlossmethodinatesting
medium as defined in this guide. in vivo. Rather, this guide provides useful boundary/endpoint
conditions for evaluating prosthesis designs in a functional
1.6 This guide does not address any potential failure mode
manner.
as it relates to the fixation of the implant to its bony interfaces.
1.12 The values stated in SI units are to be regarded as the
1.7 It is the intent of this guide to enable comparison of
standard with the exception of angular measurements, which
intervertebral disc (IVD) prostheses with regard to wear and
may be reported in either degrees or radians.
fatigue characteristics when tested under the specified condi-
1.13 This guide is not intended to be a performance stan-
tions. It must be recognized, however, that there are many
possiblevariationsintheinvivoconditions.Asinglelaboratory dard. It is the responsibility of the user of this guide to
characterizethesafetyandeffectivenessoftheprosthesisunder
simulation with a fixed set of parameters might not be
universally representative. evaluation.
1.14 This standard does not purport to address all of the
1.8 Most IVD prostheses primarily fall into two classifica-
safety concerns, if any, associated with its use. It is the
tions: articulating ball-in-socket type prostheses, and elasto-
responsibility of the user of this standard to establish appro-
meric or compliant type prostheses. For the former, this guide
priate safety and health practices and determine the applica-
primarilyaddressesMode1wear(definedherein);whereasfor
bility of regulatory limitations prior to use.
thelatter,thisguideaddressespotentialfailureoftheprosthesis
whentheimplantissubjectedtoarangeofmotionand/orloads
2. Referenced Documents
that fall within the full range of possible physiologic motions
2
and loads.
2.1 ASTM Standards:
F561 Practice for Retrieval and Analysis of Medical
1.9 For articulating components, this guide predominantly
Devices, and Associated Tissues and Fluids
describesaMode1test.Theuseriscautionedthatothermodes
F1582Terminology Relating to Spinal Implants
F1714GuideforGravimetricWearAssessmentofProsthetic
1
This guide is under the jurisdiction ofASTM Committee F04 on Medical and
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.25 on Spinal Devices. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved July 1, 2011. Published August 2011. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 2005. Last previous edition approved in 2005 as F2423–05. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F2423-11. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F2423 − 11
Hip Designs in Simulator Devices 3.2.2.3 Y-axis, n—posi
...

This document is not anASTM standard and is intended only to provide the user of anASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation:F2423–05 Designation: F2423 – 11
Standard Guide for
Functional, Kinematic, and Wear Assessment of Total Disc
1
Prostheses
This standard is issued under the fixed designation F2423; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope
1.1 This guide is intended to provide provides guidance for the functional, kinematic, and wear 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 isdoes not intended to 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 kinematic,
functional, wear and wearfatigue characteristics when tested under the specified conditions. It must be recognized, however, that
there are many possible variations in the in vivo conditions.Asingle laboratory simulation with a fixed set of parameters may not
be universally representative.
1.8In 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.
1.9Without 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 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 herein); 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, and
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, the maximum loads and motions specified in this guide represent
a severe and therefore conservative case for testing the wear properties of IVD prostheses. Because of this, a substantially greater
rate of wear may be realized than that which may occur during the routine daily activities of a typical patient. It should be noted,
however, that a full characterization of a candidate IVD prosthesis should include testing under both typical and extreme
conditions.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.25
on Spinal Devices.
Current edition approved Nov.
...