ASTM_F_1582_-_98_2016.pdf

Designation:F158298(Reapproved 2016)Standard Terminology Relating toSpinal Implants1This standard is issued under the fixed designation F1582;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 terminology covers basic terms and considerationsfor spinal implant devices and their mechanical analyses.2.Referenced Documents2.1 ASTM Standards:2E6 Terminology Relating to Methods of Mechanical TestingE1150 Definitions of Terms Relating to Fatigue(Withdrawn1996)33.TerminologyDefinitions Related to Spinal Implant Devicesanchor,ncomponents that are directly attached to the bonyelements of the spine(sacrum,lamina,pedicle,vertebralbody,spinous process,transverse process,the pelvis,orribs).assembly,na complete implant configuration(not includingspine,pelvis,ribs,or substitute material)as intended forsurgical use.band,na flexible anchor component with a noncircular crosssection that connects the bony elements of the spine,pelvis,or ribs to each other or to other implant components using aknot or similar tying mechanism,forming a locked,closedloop.bolt,nan anchor component that connects to the bonyelements of the spine,pelvis,or ribs by means of threadswith the lead threads accommodating a nut,thus sandwich-ing the bony element or implant component between the nutor washer and bolt head or other fixed stop.bolt interconnection,nan interconnection having an implantcomponent sandwiched between two nuts or between a nutand fixed stop.cable,na multi-strand,flexible longitudinal element de-signed primarily to resist axial tension loading.clamp,nan interconnection component whose mechanism tosecure the longitudinal element is through a squeezingaction.DISCUSSIONFor example,crimps,wedges,set ponent,nany single element used in an assembly.construct,na complete implant configuration attached toand including the spine,pelvis,ribs or substitute material asintended for surgical use.expansion anchor,na component that forms a connection tobony element by means of a mechanism which enlarges oncethe component is inserted into the bony elements.hook,nan anchoring component that fastens to the spine bymeans of a curved blade passed under or over lamina,transverse or spinous processes or into an anatomic orsurgically created notch or opening.hook blade,nthat portion of a spinal hook that is placedunder,over,or into a bony structure to provide attachment.hook bodythat portion of a spinal hook that connects thehook blade to the longitudinal element.hybrid longitudinal element,na longitudinal element con-sisting of two or more types of longitudinal elements ofdifferent size or cross-section manufactured into a singleelement.interbody spacer,na structure(biologic or synthetic)toreplace(partially or totally)the vertebral body or interver-tebral disk(s),or both.interconnection,nthe mechanical interface or connectionmechanism between at least two components or betweencomponents and bony elements of the spine,pelvis,or ribs.interface,none of the two mating surfaces,lines or points ofcontact within an interconnection between two components,between any component and bone,or between two bonyelements.1This terminology is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of SubcommitteeF04.25 on Spinal Devices.Current edition approved Oct.1,2016.Published October 2016.Originallyapproved in 1998.Last previous edition approved in 2011 as F1582 98(2011).DOI:10.1520/F1582-98R16.2For 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.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 intervertebral body fusion cage,na hollow device whichcontains graft material.intervertebral body fusion devices,na structure which isplaced in the disc space between two adjacent vertebralbodies to provide support for eventual arthrodeses of the twoadjacent vertebral bodies.longitudinal element,na component whose long axis isparallel,or nearly so,to the long axis of the spine.motion segment,ntwo adjacent vertebrae,the interveningdisc,and the associated ligamentous structures.partial replacement disca structure intended to restore aportion of the support and motion or a portion thereof,between adjacent vertebral bodies.plate,na longitudinal element asymmetrical in the transverseplane and designed to resist tension,compression,bending,and torsion.post,na non-threaded anchor component that connects to thebony elements of the spine,pelvis,or r