ASTM F2193-02

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Designation: F 2193 – 02
Standard Specifications and Test Methods for
Components Used in the Surgical Fixation of the Spinal
Skeletal System
This standard is issued under the fixed designation F 2193; 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 1.4 These specifications and test methods may not be
appropriateforalltypesofspinalsurgicalfixationsystems.The
1.1 These specifications and test methods are intended to
user is cautioned to consider the appropriateness of this
provide a comprehensive reference for the components of
document in view of the particular implant system and its
systems used in the surgical fixation of the spinal skeletal
potential application.
system. The document catalogs standard specifications that
1.5 This document includes the following specifications and
specify material, labeling, and handling requirements. The
test methods that are used in determining the spinal compo-
specifications and test methods also establish common termi-
nent’s mechanical performance characteristics:
nology that can be used to describe the size and other physical
1.5.1 Specification for Metallic Spinal Screws—Annex A1.
characteristics of spinal components and performance defini-
1.5.2 Specification for Metallic Spinal Plates—Annex A2.
tions related to the performance of spinal components. Addi-
1.5.3 Specification for Metallic Spinal Rods—Annex A3.
tionally, the specifications and test methods establish perfor-
1.5.4 Test Method for Measuring the Static and Fatigue
mance requirements and standard test methods to consistently
Bending Strength of Metallic Spinal Screws—Annex A4.
measure performance-related mechanical characteristics of
1.6 Unless otherwise indicated, the values stated in SI units
spinal components.
shall be regarded as the standard.
1.2 These specifications and test methods are a series of
1.7 This standard may involve hazardous materials, opera-
standards available for addressing the concerns related to
tions, and equipment. This standard does not purport to
systems used in the surgical fixation of the spinal skeletal
address all of the safety concerns, if any, associated with its
system. These specifications and test methods concentrate on
use. It is the responsibility of the user of this standard to
the individual components, which are found in many spinal
establish appropriate safety and health practices and deter-
fixation systems. If the user is interested in evaluating the next
mine the applicability of regulatory limitations prior to use.
level in the spinal fixation system chain, the interconnections
between individual components and subassemblies (two or
2. Referenced Documents
more components), the user should consult Guide F 1798.At
2.1 ASTM Standards: General
the highest level in this chain is Test Methods F 1717, which is
E4 Practices for Load Verification of Testing Machines
used to evaluate an entire construct assembled from many
E 6 Terminology Relating to Methods of Mechanical Test-
components and involves numerous interconnections and sev-
ing
eral subassemblies.
E 122 Practice for Calculating Sample Size to Estimate,
1.3 It is not the intention of these specifications and test
With a Specified Tolerable Error, the Characteristic of a
methods to define levels of performance or case-specific
Lot or Process
clinical performance for spinal components addressed by this
E 467 Practice for Verification of Constant Amplitude Dy-
document. Insufficient knowledge is available to predict the
namic Forces in an Axial Fatigue Testing System
consequences of using any of these components in individual
E 1823 Terminology Relating to Fatigue and Fracture Test-
patients for specific activities of daily living. Furthermore, it is
ing
not the intention of this document to describe or specify
E 1942 Guide for Evaluating Data Acquisition Systems
specific designs for the individual components of systems used
Used in Cyclic Fatigue and Fracture Mechanics Testing
in the surgical internal fixation of the spinal skeletal system.
F 382 Specification and Test Method for Metallic Bone
Plates
These specifications and test methods are under the jurisdiction of ASTM
Committee F04 on Medical and Surgical Materials and Devices and is the direct Annual Book of ASTM Standards, Vol 03.01.
responsibility of Subcommittee F04.25 on Spinal Devices. Annual Book of ASTM Standards, Vol 14.02.
Current edition approved June 10, 2002. Published August 2002. Annual Book of ASTM Standards, Vol 13.01.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2193–02
F 543 Specification and Test Methods for Metallic Medical 3.3.2 locking screw—a threaded anchor that is rigidly con-
Bone Screws nected to the longitudinal element of the spinal construct.
F 565 Practice for Care and Handling of Orthopaedic Im-
3.3.3 self-locking screw—a threaded anchor design that
plants and Instruments
undergoes a deformation process at the end of the insertion
F 983 Practice for Permanent Marking of Orthopedic Im-
process which results in the screw’s locking to the mating
plant Components
spinal construct element.
F 1582 Terminology Relating to Spinal Implants
3.3.4 shaft screw—a threaded anchor having an unthreaded
F 1717 Test Methods for Static and Fatigue for Spinal
shank equal to its thread diameter.
Implant Constructs in a Vertebrectomy Model
3.4 Terminology—Geometric:
F 1798 Guide for Evaluating the Static and Fatigue Proper-
ties of Interconnections Mechanisms and Subassemblies 3.4.1 rod diameter (mm)—the length of a chord passing
through the center of the rod’s cross-section.
Used in Spinal Arthrodesis Implants
F 1839 Specification for Rigid Polyurethane Foam for Use
3.4.2 rod length (mm)—the overall dimension measured
as a Standard Material for Testing Orthopaedic Devices
between the ends of a given rod.
and Instruments
3.5 Terminology—Mechanical/Structural:
2.2 ASTM Standards: Materials
3.5.1 0.2 % offset displacement (mm)—a permanent dis-
F67 Specification for Unalloyed Titanium (UNS R50250,
placement equal to 0.002 times the test gage section length for
R50400, R 50550, R50700) for Surgical ImplantApplica-
4 the specific test. The test gage section length is equal to the
tions
bending moment arm for spinal screw tests. The test gage
F 136 Specification for Wrought Titanium-6Aluminum-
section length is equal to the center span distance for spinal
4Vanadium ELI (Extra Low Interstitial) Alloy (UNS
4 plate and rod tests where the loading rollers are directly
R56401) for Surgical Implant Applications
contacting the test specimen (Fig.A2.1 and Fig.A3.1).The test
F 138 Specification for Wrought 18Chromium-14Nickel-
gage section length is equal to the unsupported distance
2.5Molybdenum Stainless Steel Bar and Wire for Surgical
betweentheendsoftheextensionsegmentsforspinalplateand
Implants (UNS S31673)
rod tests where extension segments are used to load the test
F 1295 Specification for Wrought Titanium-6Aluminum-
sample (Fig. A2.2). (distance 0B in Fig. A4.1).
7Niobium Alloy for Surgical Implant Applications
F 1314 Specification for Wrought Nitrogen Strengthened-
3.5.2 axial pull-out load (N)—the tensile force required to
22Chromium-12.5Nickel-5Manganese-2.5Molybdenum
failorremoveascrewfromamaterialintowhichthescrewhas
Stainless Steel Bar and Wire for Surgical Implants (UNS
been inserted when tested in accordance with Specification and
S20910)
Test Methods F 543, Annex A3.
F 1341 Specification for Unalloyed Titanium Wire (UNS
3.5.3 bending fatigue runout moment (N·m)—the value of
R50250) for Surgical Implant Applications
the maximum moment that can be applied to a spinal compo-
F 1472 Specification for Wrought Titanium Ti-6Al-4V Al-
nent where all of the tested samples have experienced
loy for Surgical Implant Applications (UNS R56400)
2 500 000 loading cycles without a failure at a specific R-ratio.
2.3 ISO Standards:
3.5.4 bending moment arm, L (mm)—the distance between
ISO 14630:1997 Non-active Surgical Implants—General
5 the point where the test sample is gripped (typically the axis of
Requirements
the longitudinal element) and the line-of-action for the applied
force prior to any deformation of of the assembly. (See
3. Terminology
dimension L of Fig. A4.2).
3.1 Unless otherwise defined in these specifications and test
3.5.5 bending stiffness, S (N/mm)—the slope of the initial
methods, the terminology used in this document that is related
linear elastic portion of the load versus total displacement
to spinal implants will be in accordance with the definitions of
curve (slope of line 0m in Fig. A4.1).
Specification F 382, Specification F 543, and Terminology
F 1582.
3.5.6 bending ultimate moment (N·m)—the maximum bend-
3.2 Unless otherwise defined in these specifications and test
ing moment that can be applied to a test sample. This would
methods, the terminology related to mechanical testing that is
correspond to the bending moment at Point E in Fig. A4.1.
usedinthisdocumentwillbeinaccordancewiththedefinitions
3.5.7 bending yield moment (N·m)—the bending moment
of Terminology E 6, Terminology E 1823, Specification F 382,
necessary to produce a 0.2 % offset displacement in the spinal
Terminology F 1582, Test Methods F 1717, and Guide F 1798.
component. If the specimen fractures before the test reaches
3.3 Terminology—General:
the 0.2 % offset displacement point, the bending yield moment
3.3.1 expansion head screw—a threaded anchor that is
shall be defined as the bending moment at fracture (point D in
designed so that the head can be elastically deformed, through
Fig. A4.1).
mechanicalmeans,toestablishaninterconnectionwithanother
3.5.8 exposed length (mm)—the linear distance measured
spinal construct element.
between the surface of the test block that the screw is
embedded in during the test and the location where the screw
5 is anchored (typically the axis of the longitudinal element) in
Available from International Organization for Standardization (ISO), 1 rue de
Varembe, Case postale 56, CH-1211, Geneva 20, Switzerland. the test fixture (see Fig. A4.2).
F2193–02
3.5.9 gross failure—permanent displacement resulting from 5.1.3 Rods—Standard Specification for Metallic Spinal
fracture or plastic deformation in excess of the yield displace- Rods (see Annex A3).
ment that renders the spinal component ineffective in fulfilling
its intended function. 6. Marking, Packaging, Labeling, and Handling
3.5.10 insertion depth (mm)—the linear advancement of the
6.1 Mark spinal components using the methods specified in
screwintothetestblockmeasuredrelativetoitsseatedposition
Practice F 983.
at the test block’s surface prior to testing.
6.2 Markings on spinal components shall identify the manu-
3.5.11 median bending fatigue moment at N cycles (N·m)—
facturer or distributor. When size permits, the following
the value of the maximum moment that can be applied to a
information should be legibly marked on the spinal component
spinal component for which 50 % of the test specimens of a
(items listed in order of preference):
given sample can be expected to survive N loading cycles at a
6.2.1 Manufacturer’s name or logo,
specific R-ratio.
6.2.2 Materialand,whenapplicable,theASTMdesignation,
3.5.12 permanent displacement (mm)—the total displace-
6.2.3 Catalog number,
ment remaining after the applied load has been removed from
6.2.4 Manufacturing lot number, and
the test specimen.
6.2.5 If the component is manufactured according to an
3.5.13 torsion yield moment (N·m)—the applied torque at
ASTM specification, the ASTM designation.
which the screw reaches its proportional limit when tested in
6.3 Packaging shall be adequate to protect the spinal com-
accordance with Specification and Test Methods F 543,Annex
ponent during shipment.
A1. The value is determined by using an offset method with a
2° angular offset. 6.4 Package labeling for spinal components shall include
3.5.14 total displacement (mm)—the distance, in the direc- the following information:
tion of the applied load, which the load application point has
6.4.1 Manufacturer and product name,
moved relative to the zero load intercept of the initial linear
6.4.2 Catalog number,
segment of the load versus displacement curve (point 0 in Fig.
6.4.3 Lot or serial number,
A4.1).
6.4.4 Material and, when applicable, theASTM designation
3.5.15 yield displacement (mm)—the total displacement
for the material, and
associated with the bending yield strength (distance 0A in Fig.
6.4.5 The sterility condition of the packaged spinal compo-
A4.1).
nent.
6.5 Spinal components shall be cared for and handled
4. Significance and Use
according to the requirements specified in Practice F 565.
4.1 Spinal implant constructs are typically a compilation of
several components. Screws, plates, and rods are integral
7. Materials
components of many spinal implant constructs. These compo-
7.1 The manufacturer is responsible for ensuring that mate-
nents are designed to transfer load between the bone and the
rials used to manufacture spinal components are suitable for
longitudinal or transverse element, or both. These specifica-
implanting into the body. Material suitability can be verified
tions and test methods identify specifications for such compo-
with the methods described in ISO 14630.
nents and define standard equivalent test methods that can be
7.2 The manufacturer should also consider the materials of
used when evaluating different related component designs.
other spinal components within the spinal implant construct
4.2 Since the loading of spinal components in-vivo may
whenselectingamaterial.Avoidthemixingofmaterialswithin
differ from the loading configurations addressed in these
a spinal implant construct in order to prevent the development
specifications and test methods, the results obtained from this
of undesirable corrosion conditions.
document may not predict in-vivo performance of either the
7.3 All spinal components that are made of materials that
components or the construct as a whole. Such tests can,
have an ASTM standard designation shall meet those require-
however, be used to compare different component designs in
ments given in the ASTM standards. The following is a list of
terms of relevant mechanical performance characteristics.
some materials that have been used for spinal components:
4.3 The performance-related mechanical characteristics de-
7.3.1 Unalloyed Titanium (see SpecificationF67).
termined by these specifications and test me
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