ASTM F1582-98

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: 09-Apr-1998
• 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

• Replaced By: ASTM F1582-98(2003) - Standard Terminology Relating to Spinal Implants
• Effective Date: 01-Nov-2003
• Referred By: ASTM F1717-21 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• Effective Date: 10-Apr-1998
• Referred By: ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
• Effective Date: 10-Apr-1998
• Referred By: ASTM F2423-11(2020) - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
• Effective Date: 10-Apr-1998
• Referred By: ASTM F2790-10(2019)e1 - Standard Practice for Static and Dynamic Characterization of Motion Preserving Lumbar Total Facet Prostheses
• Effective Date: 10-Apr-1998
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 10-Apr-1998
• Referred By: ASTM F3574-22 - Standard Test Methods for Sacroiliac Joint Fusion Devices
• Effective Date: 10-Apr-1998
• Referred By: ASTM F2706-18 - Standard Test Methods for Occipital-Cervical and Occipital-Cervical-Thoracic Spinal Implant Constructs in a Vertebrectomy Model
• Effective Date: 10-Apr-1998
• Referred By: ASTM F2267-22 - Standard Test Method for Measuring Load-Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression
• Effective Date: 10-Apr-1998
• Referred By: ASTM F2346-18 - Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
• Effective Date: 10-Apr-1998
• Referred By: ASTM F2077-22 - Standard Test Methods for Intervertebral Body Fusion Devices
• Effective Date: 10-Apr-1998
• Referred By: ASTM F2193-20 - Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• Effective Date: 10-Apr-1998

Standards Content (Sample)

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 1582 – 98
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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope the bony elements of the spine, pelvis, or ribs by means of a
non-threaded hole in the bony element.
1.1 This terminology covers basic terms and considerations
screw, n—an anchor component that connects to the bony
for spinal implant devices and their mechanical analyses.
elements of the spine, pelvis, or ribs by means of threads.
2. Referenced Documents staple, n—an anchor component that connects the bony
elements of the spine, pelvis, or ribs to each other or to other
2.1 ASTM Standards:
implant components by using at least two interconnected
E 6 Terminology Relating to Methods of Mechanical Test-
posts.
ing
wire—a single strand flexible anchor component with a
E 1150 Definitions of Terms Relating to Fatigue
circular cross section that connects the bony elements of the
3. Terminology
spine, pelvis, or ribs to each other or to other implant
components. A series of wire components can be bound
Definitions Related to Spinal Implant Devices
together to form a cable (see cable).
assembly, n— a complete implant configuration (not including
anchor, n—components that are directly attached to the bony
spine, pelvis, ribs, or substitute material) as intended for
elements of the spine (sacrum, lamina, pedicle, vertebral
surgical use.
body, spinous process, transverse process, the pelvis, or
component, n— any single element used in an assembly.
ribs).
construct, n— a complete implant configuration attached to
band, n—a flexible anchor component with a noncircular
and including the spine, pelvis, ribs or substitute material as
cross section that connects the bony elements of the spine,
intended for surgical use.
pelvis, or ribs to each other or to other implant components
interbody spacer, n—a structure (biologic or synthetic) to
using a knot or similar tying mechanism, forming a locked,
replace (partially or totally) the vertebral body or interver-
closed loop.
tebral disk(s), or both.
bolt, n—an anchor component that connects to the bony
intervertebral body fusion devices, n—a structure which is
elements of the spine, pelvis, or ribs by means of threads
placed in the disc space between two adjacent vertebral
with the lead threads accomodating a nut thus sandwiching
bodies to provide support for eventual arthrodeses of the two
the bony element or implant component between the nut or
adjacent vertebral bodies.
washer and bolt head or other fixed stop.
intervertebral body fusion cage, n—a hollow device which
expansion anchor, n—a component that forms a connection
contains graft material.
to bony element by means of a mechanism which enlarges
partial replacement disc—a structure intended to restore a
once the component is inserted into the bony elements.
portion of the support and motion or a portion thereof,
hook, n—an anchoring component that fastens to the spine by
between adjacent vertebral bodies.
means of a curved blade passed under or over lamina,
replacement disc, n—a structure intended to restore support
transverse or spinous processes or into an anatomic or
and motion between adjacent vertebral bodies.
surgically created notch or opening.
vertebral body replacement device, n—a structure which is
hook blade, n— that portion of a spinal hook that is placed
designed to restore anatomic position and support to a
under, over, or into a bony structure to provide attachment.
section of spine lacking one or more vertebral bodies and
hook body—that portion of a spinal hook that connects the
intervening disc(s).
hook blade to the longitudinal element.
interconnection, n—the mechanical interface or connection
post, n—a non-threaded anchor component that connects to
mechanism between at least two components or between
components and bony elements of the spine, pelvis, or ribs.
This terminology is under the jurisdiction of ASTM Committee F-4 on Medical
bolt interconnection, n—an interconnection having an im-
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
plant component sandwiched between two nuts or between a
F04.31 on Spinal Terminology.
nut and fixed stop.
Current edition approved April 10, 1998. Published September 1998.
Annual Book of ASTM Standards, Vol. 03.01. clamp, n—an interconnection component whose mechanism
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 1582
to secure the longitudinal element is through a squeezing fatigue life, n— the number of loading cycles, N, of a specified
action. character that a given specimen sustains before failure of a
specified nature occurs.
DISCUSSION—For example, crimps, wedges, set screws.
DISCUSSION—See Definitions E 1150
screw interconnection, n—an interconnection having an
−2
implant component sandwiched between the screw head (or fatigue strength at N Cycles, S [FL ], n—a value of stress
n
screw thread) and bony element or other implant compo- for failure at exactly N cycles as determined from an S-N
nents. diagram. The value S thus determined is subject to the same
n
sleeve interconnection, n—an interconnection in which an conditions as those that apply to the S-N diagram.
implant component passes through any opening that limits
DISCUSSION—The value of S which is commonly found in the
n
motion in one or more planes.
literature is the value of S (maximum stress)or S (stress amplitude)
max a
interface, n— one of the two mating surfaces, lines or points
at which 50 % of the specimens of a given sample could survive N
of contact within an interconnection between two compo-
stress cycles in which S (mean stress) 5 0. This is also known as the
m
median fatigue strength for N cycles (see Definitions E 1150).
nents, between any component and bone, or between two
bony elements.
fatigue test, n— a test designed to evaluate the cyclic load
longitudinal element, n—a component whose long axis is
properties of a material, component, interconnection, sub-
parallel, or nearly so, to the long axis of the spine.
construct, construct, subassembly, or assembly.
cable, n—a multi-strand, flexible longitudinal element de-
load ratio, R, A, n—in fatigue loading, the algebraic ratio of
signed primarily to resist axial tension load
...