ASTM F1814-97a(2009)
(Guide)Standard Guide for Evaluating Modular Hip and Knee Joint Components
Standard Guide for Evaluating Modular Hip and Knee Joint Components
SIGNIFICANCE AND USE
The tests suggested within this guide cover many different, but not all possible, areas of research and concern with regard to modular hip stems and modular knee components.
Due to the unlimited possible modular designs, this guide should be utilized as a guide for what should be considered with regard to device safety testing. There may be circumstances where alternative test methods may be useful. It is still the responsibility of the investigator to address all safety concerns that are inherent to individual modular designs.
The tests suggested herein should be utilized in such a way that the results reflect the effects of modularity, if any.
Tests that are checked in Fig. 1 or Fig. 2 or indicated in this guide as a possible test to consider may not be applicable to every implant design.
FIG. 1 Total Hip Implants
FIG. 2 Total Knee Implant
SCOPE
1.1 This guide covers a procedure to assist the developer of a modular joint replacement implant in the choice of appropriate tests and evaluations to determine device safety.
1.2 This guide does not attempt to define all test methods associated with modular device evaluation.
1.3 This guide does not cover intentional intraoperative disassembly but is meant only to suggest testing necessary to determine inadvertent disassembly loads.
1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.
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Standards Content (Sample)
NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: F1814 − 97a(Reapproved 2009)
Standard Guide for
Evaluating Modular Hip and Knee Joint Components
This standard is issued under the fixed designation F1814; 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 Part 4 Determination of Endurance Properties of Stemmed
Femoral Components With Application of Torsion
1.1 This guide covers a procedure to assist the developer of
Part 6 Determination of Endurance Properties of Head and
a modular joint replacement implant in the choice of appropri-
Neck Region of Stemmed Femoral Components
ate tests and evaluations to determine device safety.
Part 8 Endurance Performance of Stemmed Femoral Com-
1.2 This guide does not attempt to define all test methods
ponents With Application of Torsion
associated with modular device evaluation.
1.3 This guide does not cover intentional intraoperative 3. Terminology
disassembly but is meant only to suggest testing necessary to
3.1 Definitions of Terms Specific to This Standard:
determine inadvertent disassembly loads.
3.1.1 modular femoral hip implant—anydevice,constructed
1.4 This standard does not purport to address all of the
of two or more mating parts intended for implantation into the
safety concerns, if any, associated with its use. It is the
femur for the purpose of replacing the femoral hip joint.
responsibility of the user of this standard to establish appro-
3.1.1.1 bolts/screws—a fastener used to secure modular
priate safety and health practices and determine the applica-
pieces of a femoral component.
bility of regulatory limitations prior to use.
3.1.1.2 bullets/distal sleeves—modular accessories for in-
creasing the length or distal diameter of the femoral compo-
2. Referenced Documents
nent.
2.1 ASTM Standards:
3.1.1.3 collars—a medial platform located immediately dis-
F648 Specification for Ultra-High-Molecular-Weight Poly-
tal to the femoral neck.
ethylene Powder and Fabricated Form for Surgical Im-
plants 3.1.1.4 femoral head—a modular bearing, spherical in
shape, that mates with the femoral component.
F897 Test Method for Measuring Fretting Corrosion of
Osteosynthesis Plates and Screws
3.1.1.5 neck extensions—an intermediate modular couple
F1440 Practice for Cyclic Fatigue Testing of Metallic
between the femoral component and the femoral head.Attach-
Stemmed HipArthroplasty Femoral Components Without
ment can vary (for example, threads, tapers).
Torsion (Withdrawn 2012)
3.1.1.6 proximal sleeves/pads—modular accessories for
F1800 Practice for Cyclic Fatigue Testing of Metal Tibial
varying the geometry of the femoral component in the meta-
Tray Components of Total Knee Joint Replacements
physeal area.
2.2 ISO Standard:
3.1.2 modular knee implant—anydevice,constructedoftwo
ISO 7206 Implants for Surgery-Partial and Total Hip Joint
or more mating parts intended for implantation into the femur
Prosthesis
or tibia for the purpose of replacing the knee joint.
3.1.2.1 metal backed patella—a modular patellar replace-
1 ment consisting of an articular piece which is secured to a
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
Surgical Materials and Devices.
metal backing by means of a locking mechanism.
Current edition approved Feb. 1, 2009. Published March 2009. Originally
3.1.2.2 metal tibial tray—a metal component secured to the
approved in 1997. Last previous edition approved in 2003 as F1814 – 97a(2003).
DOI: 10.1520/F1814-97AR09. proximal tibia which provides mechanical support to and
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
couples directly with the modular tibial inserts.
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
3.1.2.3 stem extension or sleeve—any modular extension to
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
either a knee femoral or tibial component which extends into
The last approved version of this historical standard is referenced on
the medullary canal. A stem extension may be attached to the
www.astm.org.
femoral or tibial component by a variety of means including a
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036, http://www.ansi.org. taper, screw, etc.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F1814 − 97a (2009)
3.1.2.4 tibial insert—a modular bearing member of a tibial 5.2.3 Bending—The possibility of static disassociation un-
component, usually made in accordance with Specification der combined loading. Consider the following:
F648, that is secured to a knee tibial tray by means of a locking 5.2.3.1 Reporting a load-versus-deflection curve.
mechanism. 5.2.4 Torsion—The torque required to disconnect the com-
ponents (for example, bolt or screw). This may only be
3.1.2.5 wedge—a modular addition to a total knee replace-
applicable for threaded connections.
ment that serves the function of filling voids left by deficient or
5.3 Cyclic Fatigue Properties—The nature of in vivo load-
absent bone stock.
ing generates the need for cyclic fatigue evaluation. Tests
should be designed to examine pre-cycle and post-cycle
4. Significance and Use
properties to gain an understanding of how the design
4.1 The tests suggested within this guide cover many
withstands, and is affected by, cyclic loading.
different, but not all possible, areas of research and concern
5.3.1 Fracture—The possibility of fracture of either a
with regard to modular hip stems and modular knee compo-
modular construct or the connections under fatigue loading.
nents.
Consider the following:
4.2 Due to the unlimited possible modular designs, this
5.3.1.1 Loading that represents that applied to the compo-
guide should be utilized as a guide for what should be
nent in vivo,
considered with regard to device safety testing. There ma
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