ASTM F1582-98(2011)

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: 30-Nov-2011
• 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(2003) - Standard Terminology Relating to Spinal Implants
• Effective Date: 01-Dec-2011
• Replaced By: ASTM F1582-98(2016) - Standard Terminology Relating to Spinal Implants
• Effective Date: 01-Oct-2016
• Referred By: ASTM F3574-22 - Standard Test Methods for Sacroiliac Joint Fusion Devices
• 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-Dec-2011
• Referred By: ASTM F1717-21 - Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• Effective Date: 01-Dec-2011
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 01-Dec-2011
• 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-Dec-2011
• 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-Dec-2011
• 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-Dec-2011
• Referred By: ASTM F2077-22 - Standard Test Methods for Intervertebral Body Fusion Devices
• Effective Date: 01-Dec-2011
• Referred By: ASTM F3292-19 - Standard Practice for Inspection of Spinal Implants Undergoing Testing
• Effective Date: 01-Dec-2011
• Referred By: ASTM F2346-18 - Standard Test Methods for Static and Dynamic Characterization of Spinal Artificial Discs
• Effective Date: 01-Dec-2011
• Referred By: ASTM F2423-11(2020) - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
• Effective Date: 01-Dec-2011

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 2011)
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—an anchoring component that fastens to the spine by
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:
E6 Terminology Relating to Methods of Mechanical Testing
hook body—that portion of a spinal hook that connects the
E1150 Definitions of Terms Relating to Fatigue (Withdrawn
hook blade to the longitudinal element.
1996)
post, n—a non-threaded anchor component that connects to
the bony elements of the spine, pelvis, or ribs by means of a
3. Terminology
non-threaded hole in the bony element.
Definitions Related to Spinal Implant Devices
screw, n—an anchor component that connects to the bony
anchor, n—components that are directly attached to the bony
elements of the spine, pelvis, or ribs by means of threads.
elements of the spine (sacrum, lamina, pedicle, vertebral
staple, n—an anchor component that connects the bony
body, spinous process, transverse process, the pelvis, or
elements of the spine, pelvis, or ribs to each other or to other
ribs).
implant components by using at least two interconnected
band, n—a flexible anchor component with a noncircular
posts.
cross section that connects the bony elements of the spine,
wire—a single strand flexible anchor component with a
pelvis, or ribs to each other or to other implant components
circular cross section that connects the bony elements of the
using a knot or similar tying mechanism, forming a locked,
spine, pelvis, or ribs to each other or to other implant
closed loop.
components. A series of wire components can be bound
bolt, n—an anchor component that connects to the bony
together to form a cable (see cable).
elements of the spine, pelvis, or ribs by means of threads
assembly, n—a complete implant configuration (not including
with the lead threads accomodating a nut thus sandwiching
spine, pelvis, ribs, or substitute material) as intended for
the bony element or implant component between the nut or
surgical use.
washer and bolt head or other fixed stop.
component, n—any single element used in an assembly.
expansion anchor, n—a component that forms a connection
to bony element by means of a mechanism which enlarges
construct, n—a complete implant configuration attached to
once the component is inserted into the bony elements.
and including the spine, pelvis, ribs or substitute material as
intended for surgical use.
interbody spacer, n—a structure (biologic or synthetic) to
ThisterminologyisunderthejurisdictionofASTMCommitteeF04onMedical
replace (partially or totally) the vertebral body or interver-
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.25 on Spinal Devices. tebral disk(s), or both.
Current edition approved Dec. 1, 2011. Published January 2012. Originally
approved in 1998. Last previous edition approved in 2003 as F1582 – 98 (2003). intervertebral body fusion devices, n—a structure which is
DOI: 10.1520/F1582-98R11.
placed in the disc space between two adjacent vertebral
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
bodies to provide support for eventual arthrodeses of the two
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
adjacent vertebral bodies.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
intervertebral body fusion cage,n—a hollow device which
The last approved version of this historical standard is referenced on
www.astm.org. contains graft material.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1582 − 98 (2011)
partial replacement disc—a structure intended to restore a subconstruct, n—any portion of an implant construct that is
portion of the support and motion or a portion thereof, composed of two or more components including the spine,
between adjacent vertebral bodies. pelvis, ribs, or substitute structure.
transverse element, n—a component or subassembly that
replacement disc, n—a structure intended to restore support
links longitudinal members together.
and motion between adjacent vertebral bodies.
vertebral span,n—the number of vertebra that are spanned by
vertebral body replacement device, n—a structure which is
the longitudinal element, including the vertebrae containing
designed to restore anatomic position and support to a
anchor components.
section of spine lacking one or more vertebral bodies and
intervening disc(s).
Definitions Related to Spinal Implant Testing Defined in
Other Documents, or are Established Terminology
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.
DISCUSSION—In certain instances, a value for moment or load can be
substituted for stress when describing fatigue life. This is true in cases
bolt interconnection, n—an interconnection having an im-
in which the actual stress values are unknown or not easily obtainable.
plant component sandwiched between two nuts or between a
The moment or load can be substituted when comparing devices
nut and fixed stop.
assigned to perform the same mechanical function. The value for load
or moment thus determined is subject to the same conditions as those
clamp, n—an interconnection component whose mechanism
that apply to stress in this terminology standard. However, whenever
to secure the longitudinal element is through a squeezing
possible, stress should be the standard employed.
action.
fatigue, n—the process of progressive localized permanent
DISCUSSION—For example, crimps, wedges, set screws.
structural change occurring in a material subjected to con-
ditions that produce fluctuating stresses and strains at some
screw interconnection, n—an interconnection having an
point or points and that may culminate in cracks or complete
implant component sandwiched between the screw head (or
fracture after a sufficient number of fluctuations.
screw thread) and bony element or other implant compo-
DISCUSSION—See Definitions E1150.
nents.
...