1、Designation:F158298(Reapproved 2011)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 paren
2、theses 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:2E
3、6 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 pr
4、ocess,transverse process,the pelvis,orribs).band,na flexible anchor component with a noncircularcross section that connects the bony elements of the spine,pelvis,or ribs to each other or to other implant componentsusing a knot or similar tying mechanism,forming a locked,closed loop.bolt,nan anchor c
5、omponent that connects to the bonyelements of the spine,pelvis,or ribs by means of threadswith the lead threads accomodating a nut thus sandwichingthe bony element or implant component between the nut orwasher and bolt head or other fixed stop.expansion anchor,na component that forms a connectionto
6、bony element by means of a mechanism which enlargesonce the 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 open
7、ing.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.post,na non-threaded anchor component that connects tothe bony elements of the spine,pe
8、lvis,or ribs by means of anon-threaded hole in the bony element.screw,nan anchor component that connects to the bonyelements of the spine,pelvis,or ribs by means of threads.staple,nan anchor component that connects the bonyelements of the spine,pelvis,or ribs to each other or to otherimplant compone
9、nts by using at least two interconnectedposts.wirea single strand flexible anchor component with acircular cross section that connects the bony elements of thespine,pelvis,or ribs to each other or to other implantcomponents.A series of wire components can be boundtogether to form a cable(see cable).
10、assembly,na complete implant configuration(not includingspine,pelvis,ribs,or substitute material)as intended forsurgical 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 sur
11、gical use.interbody spacer,na structure(biologic or synthetic)toreplace(partially or totally)the vertebral body or interver-tebral disk(s),or both.intervertebral body fusion devices,na structure which isplaced in the disc space between two adjacent vertebralbodies to provide support for eventual art
12、hrodeses of the twoadjacent vertebral bodies.intervertebral body fusion cage,na hollow device whichcontains graft material.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 De
13、vices.Current edition approved Dec.1,2011.Published January 2012.Originallyapproved in 1998.Last previous edition approved in 2003 as F1582 98(2003).DOI:10.1520/F1582-98R11.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annua
14、l 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
15、 partial replacement disca structure intended to restore aportion of the support and motion or a portion thereof,between adjacent vertebral bodies.replacement disc,na structure intended to restore supportand motion between adjacent vertebral bodies.vertebral body replacement device,na structure whic
16、h isdesigned to restore anatomic position and support to asection of spine lacking one or more vertebral bodies andintervening disc(s).interconnection,nthe mechanical interface or connectionmechanism between at least two components or betweencomponents and bony elements of the spine,pelvis,or ribs.bolt interconnection,nan interconnection having an im-plant component sandwiched between two nuts or between anut and fixed stop.clamp,nan interconnection component whose mechanismto secure the longitu
