ASTM F1814-97a(2003)
(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 diassembly 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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Designation:F1814–97a (Reapproved 2003)
Standard Guide for
Evaluating Modular Hip and Knee Joint Components
This standard is issued under the fixed designation F 1814; 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 Part 8 Endurance Performance of Stemmed Femoral Com-
ponents With Application of Torsion
1.1 This guide covers a procedure to assist the developer of
a modular joint replacement implant in the choice of appropri-
3. Terminology
ate tests and evaluations to determine device safety.
3.1 Definitions of Terms Specific to This Standard:
1.2 This guide does not attempt to define all test methods
3.1.1 modular femoral hip implant—any device, con-
associated with modular device evaluation.
structed of two or more mating parts intended for implantation
1.3 This guide does not cover intentional intraoperative
into the femur for the purpose of replacing the femoral hip
disassembly but is meant only to suggest testing necessary to
joint.
determine inadvertent disassembly loads.
3.1.1.1 bolts/screws—a fastener used to secure modular
1.4 This standard does not purport to address all of the
pieces of a femoral component.
safety concerns, if any, associated with its use. It is the
3.1.1.2 bullets/distal sleeves—modular accessories for in-
responsibility of the user of this standard to establish appro-
creasing length or distal diameter of the femoral component.
priate safety and health practices and determine the applica-
3.1.1.3 collars—a medial platform located immediately dis-
bility of regulatory limitations prior to use.
tal to the femoral neck.
2. Referenced Documents 3.1.1.4 femoral head—a modular bearing, spherical in
shape, that mates with the femoral component.
2.1 ASTM Standards:
3.1.1.5 neck extensions—an intermediate modular couple
F 648 Specification for Ultra-High-Molecular-Weight Poly-
between the femoral component and the femoral head.Attach-
ethylene Powder and Fabricated Form for Surgical Im-
ment can vary (for example, threads, tapers).
plants
3.1.1.6 proximal sleeves/pads—modular accessories for
F 897 Test Method for Measuring Fretting Corrosion of
2 varying the geometry of the femoral component in the meta-
Osteosynthesis Plates and Screws
physeal area.
F 1440 Practice for Cyclic Fatigue Testing of Metallic
3.1.2 modular knee implant—any device, constructed of
Stemmed Hip Arthroplasty Femoral Components Without
two or more mating parts intended for implantation into the
Torsion
femur or tibia for the purpose of replacing the knee joint.
F 1800 Test Method for Cyclic Fatigue Testing of Metal
3.1.2.1 metal backed patella—a modular patellar replace-
Tibial Components of Total Knee Joint Replacements
ment consisting of an articular piece which is secured to a
2.2 ISO Standard:
metal backing by means of a locking mechanism.
ISO 7206 Implants for Surgery-Partial and Total Hip Joint
3 3.1.2.2 metal tibial tray—a metal component secured to the
Prosthesis
proximal tibia which provides mechanical support to and
Part 4 Determination of Endurance Properties of Stemmed
3 couples directly with the modular tibial inserts.
Femoral Components With Application of Torsion
3.1.2.3 stem extensions or sleeve—any modular extension
Part 6 Determination of Endurance Properties of Head and
toeitherakneefemoralortibialcomponentwhichextendsinto
Neck Region of Stemmed Femoral Components
the medullary canal. Stem extensions may be attached to the
femoral or tibial component by a variety of means including
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
tapers, screws, etc.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
3.1.2.4 tibial insert—a modular bearing member of a tibial
F04.22 on Arthroplasty.
component, usually made in accordance with Specification
Current edition approved Apr. 10, 2003. Published June 2003. Originally
approved in 1997. Last previous edition approved in 1997 as F 1814 – 97a.
F 648,thatissecuredtoakneetibialtraybymeansofalocking
Annual Book of ASTM Standards, Vol 13.01.
mechanism.
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036.
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F1814–97a (2003)
3.1.2.5 wedge—a modular addition to a total knee replace- 5.2.4 Torsion—The torque required to disconnect the com-
ment that serves the function of filling voids left by deficient or ponents (for example, bolt or screw). This may only be
absent bone stock. applicable for threaded connections.
5.3 Cyclic Fatigue Properties—The nature of in vivo load-
ing generates the need for cyclic fatigue evaluation. Tests
4. Significance and Use
should be designed to examine pre-cycle and post-cycle
4.1 The tests suggested within this guide cover many
properties to gain an understanding of how the design with-
different, but not all possible, areas of research and concern
stands, and is affected by, cyclic loading.
with regard to modular hip stems and modular knee compo-
5.3.1 Fracture—The possibility of fracture of either a
nents.
modular construct or the connections under fatigue loading.
4.2 Due to the unlimited possible modular designs, this
Consider the following:
guide should be utilized as a guide for what should be
5.3.1.1 Loading that represents that applied to the compo-
considered with regard to device safety testing. There may be
nent in vivo,
circumstances where alternative test methods may be useful. It
5.3.1.2 An P-N curve to determine the load levels at which
is still the responsibility of the investigator to address all s
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