ASTM_F_2423_-_11.pdf

Designation:F242311Standard Guide forFunctional,Kinematic,and Wear Assessment of Total DiscProstheses1This standard is issued under the fixed designation F2423;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This guide provides guidance for wear and/or fatiguetesting of total disc prostheses under functional and kinematicconditions and,to this end,describes test methods for assess-ment of the wear or functional characteristics,or both,of totaldisc prostheses.1.2 Both lumbar and cervical prostheses are addressed.1.3 Load and kinematic profiles for lumbar and cervicaldevices are not identical and,therefore,are addressed sepa-rately in the guide.1.4 Partial disc replacements,such as nucleus replacementsor facet joint replacements,are not intended to be addressed.1.5 Wear is assessed using a weight loss method in a testingmedium as defined in this guide.1.6 This guide does not address any potential failure modeas it relates to the fixation of the implant to its bony interfaces.1.7 It is the intent of this guide to enable comparison ofintervertebral disc(IVD)prostheses with regard to wear andfatigue characteristics when tested under the specified condi-tions.It must be recognized,however,that there are manypossible variations in the in vivo conditions.Asingle laboratorysimulation with a fixed set of parameters might not beuniversally representative.1.8 Most IVD prostheses primarily fall into two classifica-tions:articulating ball-in-socket type prostheses,and elasto-meric or compliant type prostheses.For the former,this guideprimarily addresses Mode 1 wear(defined herein);whereas forthe latter,this guide addresses potential failure of the prosthesiswhen the implant is subjected to a range of motion and/or loadsthat fall within the full range of possible physiologic motionsand loads.1.9 For articulating components,this guide predominantlydescribes a Mode 1 test.The user is cautioned that other modesof wear may occur and may have significant influence on thefunctionality and performance of an articulating IVDprosthesis,and therefore the user should consider the effects ofother wear modes on the performance of the prosthesis.1.10 In order that the data be reproducible and comparablewithin and between laboratories,it is essential that uniformprocedures are established.This guide is intended to facilitateuniform methods for testing and reporting of data for total discreplacement prostheses.1.11 Without a substantial clinical retrieval history of IVDprostheses,actual loading profiles and patterns cannot bedelineated at the time of the writing of this guide.It thereforefollows that the load and motion conditions specified by thisguide do not necessarily accurately reproduce those occurringin vivo.Rather,this guide provides useful boundary/endpointconditions for evaluating prosthesis designs in a functionalmanner.1.12 The values stated in SI units are to be regarded as thestandard with the exception of angular measurements,whichmay be reported in either degrees or radians.1.13 This guide is not intended to be a performance stan-dard.It is the responsibility of the user of this guide tocharacterize the safety and effectiveness of the prosthesis underevaluation.1.14 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2F561 Practice for Retrieval and Analysis of MedicalDevices,and Associated Tissues and FluidsF1582 Terminology Relating to Spinal ImplantsF1714 Guide for Gravimetric WearAssessment of Prosthetic1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.25 on Spinal Devices.Current edition approved July 1,2011.Published August 2011.Originallyapproved in 2005.Last previous edition approved in 2005 as F2423 05.DOI:10.1520/F2423-11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 Hip Designs in Simulator DevicesF1877 Practice for Characterization of ParticlesF2077 Test Methods For Intervertebral Body Fusion Devices2.2 ISO Standard:3ISO 181921 Implants for SurgeryWear of Total Interver-tebral Spinal Disc ProsthesesPart 1:Loading and Dis-placement Parameters for Wear Testing and Correspond-ing Environmental Condition