ASTM F1582-98(2003)

Standard Terminology Relating to Spinal Implants

SCOPE
1.1 This terminology covers basic terms and considerations for spinal implant devices and their mechanical analyses.

General Information

• Status: Historical
• Publication Date: 31-Oct-2003
• ICS: 01.040.11 - Health care technology (Vocabularies)
• 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 F1582-98 - Standard Terminology Relating to Spinal Implants
• Effective Date: 01-Nov-2003
• Replaced By: ASTM F1582-98(2011) - Standard Terminology Relating to Spinal Implants
• Effective Date: 01-Dec-2011
• Referred By: ASTM F2790-10(2019)e1 - Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
• Effective Date: 01-Nov-2003
• Referred By: ASTM F3574-22 - Standard Test Methods for Sacroiliac Joint Fusion Devices
• Effective Date: 01-Nov-2003
• Referred By: ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
• Effective Date: 01-Nov-2003
• Referred By: ASTM F2423-11(2020) - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
• Effective Date: 01-Nov-2003
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 01-Nov-2003
• Referred By: ASTM F2346-18 - Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
• Effective Date: 01-Nov-2003
• Referred By: ASTM F2077-22 - Standard Test Methods for Intervertebral Body Fusion Devices
• Effective Date: 01-Nov-2003
• Referred By: ASTM F2267-22 - Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
• Effective Date: 01-Nov-2003
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 01-Nov-2003
• Referred By: ASTM F2706-18 - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
• Effective Date: 01-Nov-2003
• Referred By: ASTM F1717-21 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• Effective Date: 01-Nov-2003

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:F1582–98 (Reapproved 2003)
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 hook,n—ananchoringcomponentthatfastenstothespineby
means of a curved blade passed under or over lamina,
1.1 This terminology covers basic terms and considerations
transverse or spinous processes or into an anatomic or
for spinal implant devices and their mechanical analyses.
surgically created notch or opening.
2. Referenced Documents
hook blade, n—that portion of a spinal hook that is placed
under, over, or into a bony structure to provide attachment.
2.1 ASTM Standards:
hook body—that portion of a spinal hook that connects the
E6 Terminology Relating to Methods of Mechanical Test-
hook blade to the longitudinal element.
ing
post, n—a non-threaded anchor component that connects to
E1150 Definition of Terms Relating to Fatigue
the bony elements of the spine, pelvis, or ribs by means of a
3. Terminology
non-threaded hole in the bony element.
screw, n—an anchor component that connects to the bony
Definitions Related to Spinal Implant Devices
elements of the spine, pelvis, or ribs by means of threads.
staple, n—an anchor component that connects the bony
anchor, n—components that are directly attached to the bony
elements of the spine, pelvis, or ribs to each other or to other
elements of the spine (sacrum, lamina, pedicle, vertebral
implant components by using at least two interconnected
body, spinous process, transverse process, the pelvis, or
posts.
ribs).
wire—a single strand flexible anchor component with a
band, n—a flexible anchor component with a noncircular
circular cross section that connects the bony elements of the
cross section that connects the bony elements of the spine,
spine, pelvis, or ribs to each other or to other implant
pelvis, or ribs to each other or to other implant components
components. A series of wire components can be bound
using a knot or similar tying mechanism, forming a locked,
together to form a cable (see cable).
closed loop.
assembly, n—a complete implant configuration (not including
bolt, n—an anchor component that connects to the bony
spine, pelvis, ribs, or substitute material) as intended for
elements of the spine, pelvis, or ribs by means of threads
surgical use.
with the lead threads accomodating a nut thus sandwiching
component, n—any single element used in an assembly.
the bony element or implant component between the nut or
construct, n—a complete implant configuration attached to
washer and bolt head or other fixed stop.
and including the spine, pelvis, ribs or substitute material as
expansion anchor, n—a component that forms a connection
intended for surgical use.
to bony element by means of a mechanism which enlarges
interbody spacer, n—a structure (biologic or synthetic) to
once the component is inserted into the bony elements.
replace (partially or totally) the vertebral body or interver-
tebral disk(s), or both.
intervertebral body fusion devices, n—a structure which is
ThisterminologyisunderthejurisdictionofASTMCommitteeF04onMedical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
placed in the disc space between two adjacent vertebral
F04.25 on Spinal Devices.
bodies to provide support for eventual arthrodeses of the two
Current edition approved Nov. 1, 2003. Published November 2003. Originally
adjacent vertebral bodies.
approved in 1998. Last previous edition approved in 1998 as F1582 – 98. DOI:
intervertebralbodyfusioncage,n—ahollowdevicewhich
10.1520/F1582-98R03.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contains graft material.
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
partial replacement disc—a structure intended to restore a
Standards volume information, refer to the standard’s Document Summary page on
portion of the support and motion or a portion thereof,
the ASTM website.
Withdrawn. between adjacent vertebral bodies.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F1582–98 (2003)
replacement disc, n—a structure intended to restore support Definitions Related to Spinal Implant Testing Defined in
and motion between adjacent vertebral bodies. Other Documents, or are Established Terminology
vertebral body replacement device, n—a structure which is
DISCUSSION—In certain instances, a value for moment or load can be
designed to restore anatomic position and support to a
substituted for stress when describing fatigue life. This is true in cases
section of spine lacking one or more vertebral bodies and
in which the actual stress values are unknown or not easily obtainable.
intervening disc(s). The moment or load can be substituted when comparing devices
assigned to perform the same mechanical function. The value for load
interconnection, n—the mechanical interface or connection
or moment thus determined is subject to the same conditions as those
mechanism between at least two components or between
that apply to stress in this terminology standard. However, whenever
components and bony elements of the spine, pelvis, or ribs.
possible, stress should be the standard employed.
bolt interconnection, n—an interconnection having an im-
plant component sandwiched between two nuts or between a fatigue, n—the process of progressive localized permanent
nut and fixed stop. structural change occurring in a material subjected to con-
clamp, n—an interconnection component whose mechanism ditions that produce fluctuating stresses and strains at some
to secure the longitudinal element is through a squeezing point or points and that may culminate in cracks or complete
action. fracture after a sufficient number of fluctuations.
DISCUSSION—For example, crimps, wedges, set screws. DISCUSSION—See Definitions E1150.
screw interconnection, n—an interconnection having an fatiguelife, n—the number of loading cycles, N, of a specified
implant component sandwiched between the screw head (or character that a given specimen sustains before failure of a
screw thread) and bony element or other implant compo- specified nature occurs.
nents.
DISCUSSION—See Definitions E1150
sleeve interconnection, n—an interconnection in which an
−2
fatigue strength at N Cycles, S [FL ], n—a value of stress
implant component passes through any opening that limits
n
for failure at exactly N cycles as determined from an S-N
motion in one or more
...

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:F1582–98 Designation: F 1582 – 98 (Reapproved 2003)
Standard Terminology Relating to
Spinal Implants
This standard is issued under the fixed designation F 1582; 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 terminology covers basic terms and considerations for spinal implant devices and their mechanical analyses.
2. Referenced Documents
2.1 ASTM Standards:
E6 Terminology Relating to Methods of Mechanical Testing
E 1150 Definitions of Terms Relating to Fatigue
3. Terminology
Definitions Related to Spinal Implant Devices
anchor, n—components that are directly attached to the bony elements of the spine (sacrum, lamina, pedicle, vertebral body,
spinous process, transverse process, the pelvis, or ribs).
band, n—a flexible anchor component with a noncircular cross section that connects the bony elements of the spine, pelvis, or
ribs to each other or to other implant components using a knot or similar tying mechanism, forming a locked, closed loop.
bolt, n—an anchor component that connects to the bony elements of the spine, pelvis, or ribs by means of threads with the lead
threads accomodating a nut thus sandwiching the bony element or implant component between the nut or washer and bolt head
or other fixed stop.
expansion anchor, n— a component that forms a connection to bony element by means of a mechanism which enlarges once
the component is inserted into the bony elements.
hook, n—an anchoring component that fastens to the spine by means of a curved blade passed under or over lamina, transverse
or spinous processes or into an anatomic or surgically created notch or opening.
hook blade, n— that portion of a spinal hook that is placed under, over, or into a bony structure to provide attachment.
hook body—that portion of a spinal hook that connects the hook blade to the longitudinal element.
post, n—a non-threaded anchor component that connects to the bony elements of the spine, pelvis, or ribs by means of a
non-threaded hole in the bony element.
screw, n—an anchor component that connects to the bony elements of the spine, pelvis, or ribs by means of threads.
staple, n—an anchor component that connects the bony elements of the spine, pelvis, or ribs to each other or to other implant
components by using at least two interconnected posts.
wire—asinglestrandflexibleanchorcomponentwithacircularcrosssectionthatconnectsthebonyelementsofthespine,pelvis,
or ribs to each other or to other implant components. A series of wire components can be bound together to form a cable (see
cable).
assembly, n—a complete implant configuration (not including spine, pelvis, ribs, or substitute material) as intended for surgical
use.
component, n—any single element used in an assembly.
construct, n—a complete implant configuration attached to and including the spine, pelvis, ribs or substitute material as intended
for surgical use.
This terminology is under the jurisdiction of ASTM Committee F-4 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.31 on Spinal Terminology.
Current edition approved April 10, 1998. Published September 1998.
This terminology 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. 1, 2003. Published November 2003. Originally approved in 1998. Last previous edition approved in 1998 as F 1582 – 98.
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM Customer Service at [e-mail]. For Annual Book ofASTM Standards
, Vol. 03.01.volume information, refer to the standard’s Document Summary page on the ASTM website.
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 1582 – 98 (2003)
interbodyspacer, n—a structure (biologic or synthetic) to replace (partially or totally) the vertebral body or intervertebral disk(s),
or both.
intervertebral body fusion devices, n—a structure which is placed in the disc space between two adjacent vertebral bodies to
provide support for eventual arthrodeses of the two adjacent vertebral bodies.
intervertebral body fusion cage, n—a hollow device which contains graft material.
partial replacement disc— a structure intended to restore a portion of the support and motion or a portion thereof, between
adjacent vertebral bodies.
replacement disc, n— a structure intended to restore support and motion between adjacent vertebral bodies.
vertebral body replacement device, n—a structure which is designed to restore anatomic position and support to a section of
spine lacking one or more vertebral bodies and intervening disc(s).
interconnection, n—the mechanical interface or connection mechanism between at least two components or between components
and bony elements of the spine, pelvis, or ribs.
bolt interconnection, n—an interconnection having an implant component sandwiched between two nuts or between a nut and
fixed stop.
clamp, n—an interconnection component whose mechanism to secure the longitudinal element is through a squeezing action.
DISCUSSION—For example, crimps, wedges, set screws.
screw interconnection, n—an interconnection having an implant component sandwiched between the screw head (or screw
thread) and bony element or other implant components.
sleeve interconnection, n—an interconnection in which an implant component passes through any opening that limits motion in
one or more planes.
interface, n—one of the two mating surfaces, lines or points of contact within an interconnection between two components,
between any component and bone, or between two bony elements.
longitudinal element, n— a component whose long axis is parallel, or nearly so, to the long axis of the spine.
cable, n—a multi-strand, flexible longitudinal element designed primarily to resist axial tension loading.
hybrid longitudinal element, n—a longitudinal element consisting of two or more types of longitudinal elements of different
size or cross-section manufactured into a single element.
plate, n—a longitudinal element asymmetrical in the transverse plane and designed to resist tension, compression, bending, and
torsion.
rod, n—a longitudinal element symmetrical in the transverse plane designed to resist tension, compression, bending, and torsion.
motion segment, n—two adjacent vertebrae, the intervening disc, and the
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