ASTM F1582-98(2016)

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.
Designation: F1582 − 98 (Reapproved 2016)
Standard Terminology Relating to
Spinal Implants
This standard is issued under the fixed designation F1582; 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 bolt interconnection,n—aninterconnectionhavinganimplant
component sandwiched between two nuts or between a nut
1.1 This terminology covers basic terms and considerations
and fixed stop.
for spinal implant devices and their mechanical analyses.
cable, n—a multi-strand, flexible longitudinal element de-
2. Referenced Documents
signed primarily to resist axial tension loading.
2.1 ASTM Standards:
clamp,n—an interconnection component whose mechanism to
E6 Terminology Relating to Methods of Mechanical Testing
secure the longitudinal element is through a squeezing
E1150 Definitions of Terms Relating to Fatigue (Withdrawn
action.
1996)
DISCUSSION—For example, crimps, wedges, set screws.
3. Terminology
component, n—any single element used in an assembly.
Definitions Related to Spinal Implant Devices construct, n—a complete implant configuration attached to
and including the spine, pelvis, ribs or substitute material as
anchor, n—components that are directly attached to the bony
intended for surgical use.
elements of the spine (sacrum, lamina, pedicle, vertebral
body, spinous process, transverse process, the pelvis, or expansion anchor, n—a component that forms a connection to
ribs). bonyelementbymeansofamechanismwhichenlargesonce
the component is inserted into the bony elements.
assembly, n—a complete implant configuration (not including
hook, n—an anchoring component that fastens to the spine by
spine, pelvis, ribs, or substitute material) as intended for
surgical use. means of a curved blade passed under or over lamina,
transverse or spinous processes or into an anatomic or
band,n—a flexible anchor component with a noncircular cross
surgically created notch or opening.
section that connects the bony elements of the spine, pelvis,
hook blade, n—that portion of a spinal hook that is placed
or ribs to each other or to other implant components using a
under, over, or into a bony structure to provide attachment.
knot or similar tying mechanism, forming a locked, closed
loop.
hook body—that portion of a spinal hook that connects the
hook blade to the longitudinal element.
bolt, n—an anchor component that connects to the bony
elements of the spine, pelvis, or ribs by means of threads
hybrid longitudinal element, n—a longitudinal element con-
with the lead threads accommodating a nut, thus sandwich-
sisting of two or more types of longitudinal elements of
ing the bony element or implant component between the nut
different size or cross-section manufactured into a single
or washer and bolt head or other fixed stop.
element.
interbody spacer, n—a structure (biologic or synthetic) to
replace (partially or totally) the vertebral body or interver-
ThisterminologyisunderthejurisdictionofASTMCommitteeF04onMedical
tebral disk(s), or both.
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.25 on Spinal Devices.
interconnection, n—the mechanical interface or connection
Current edition approved Oct. 1, 2016. Published October 2016. Originally
approved in 1998. Last previous edition approved in 2011 as F1582 – 98 (2011). mechanism between at least two components or between
DOI: 10.1520/F1582-98R16.
components and bony elements of the spine, pelvis, or ribs.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
interface,n—one of the two mating surfaces, lines or points of
Standards volume information, refer to the standard’s Document Summary page on
contact within an interconnection between two components,
the ASTM website.
between any component and bone, or between two bony
The last approved version of this historical standard is referenced on
www.astm.org. elements.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1582 − 98 (2016)
intervertebral body fusion cage, n—a hollow device which vertebral span,n—the number of vertebra that are spanned by
contains graft material. the longitudinal element, including the vertebrae containing
anchor components.
intervertebral body fusion devices, n—a structure which is
placed in the disc space between two adjacent vertebral wire, n—a single strand flexible anchor component with a
bodies to provide support for eventual arthrodeses of the two
circular cross section that connects the bony elements of the
adjacent vertebral bodies.
spine, pelvis, or ribs to each other or to other implant
components. A series of wire components can be bound
longitudinal element, n—a component whose long axis is
together to form a cable (see cable).
parallel, or nearly so, to the long axis of the spine.
Definitions Related to Spinal Implant Testing Defined in
motion segment, n—two adjacent vertebrae, the intervening
Other Documents, or Established Terminology
disc, and the associated ligamentous structures.
DISCUSSION—In certain instances, a value for moment or load can be
partial replacement disc—a structure intended to restore a
substituted for stress when describing fatigue life. This is true in cases
portion of the support and motion or a portion thereof,
in which the actual stress values are unknown or not easily obtainable.
between adjacent vertebral bodies.
The moment or load can be substituted when comparing devices
assigned to perform the same mechanical function. The value for load
plate,n—alongitudinalelementasymmetricalinthetransverse
or moment thus determined is subject to the same conditions as those
plane and designed to resist tension, compression, bending,
that apply to stress in this terminology standard. However, whenever
and torsion. possible, stress should be the standard employed.
fatigue, n—the process of progressive localized permanent
post,n—a non-threaded anchor component that connects to the
bony elements of the spine, pelvis, or ribs by means of a structural change occurring in a material subjected to con-
non-threaded hole in the bony element. ditions that produce fluctuating stresses and strains at some
point or points and that may culminate in cracks or complete
replacement disc, n—a structure intended to restore support
fracture after a sufficient number of fluctuations.
and motion between adjacent vertebral bodies.
DISCUSSION—See Definitions E1150.
rod, n—a longitudinal element symmetrical in the
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