ASTM F1829-98(2003)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F1829–98 (Reapproved 2003)
Standard Test Method for
Static Evaluation of Glenoid Locking Mechanism in Shear
This standard is issued under the fixed designation F 1829; 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 3.1.4 glenoid component—the prosthetic portion that re-
places the glenoid fossa of the scapula and articulates with the
1.1 This test method covers a method for determining the
natural humeral head or a prosthetic replacement.
static shear disassembly force of modular glenoid components
used in shoulder prostheses. It is intended to be used as a
4. Significance and Use
design validation and for comparison with other prostheses.
4.1 This test method can be used to describe the effects of
1.2 This test method covers modular glenoid components
materials, manufacturing, and design variables on the perfor-
comprised of a separate articular insert and backing. The insert
manceofmetalbackedglenoidprostheseslockingmechanisms
and backing can be fabricated from any combination of the
to resist static shear loading.
following materials: metal alloys, polymeric materials, com-
4.2 The glenoid component is used in shoulder replace-
posite materials.
ments and should conform to the criteria specified in Specifi-
1.3 The values stated in SI units are regarded as the
cation F 1378.
standard.
4.3 The loading of metal backed glenoid prostheses in vivo
1.4 This standard does not purport to address all of the
will, in general, differ from the loading defined in this test
safety concerns, if any, associated with its use. It is the
method. The results obtained here can not be used to directly
responsibility of the user of this standard to establish appro-
predict in vivo performance. However, this test method is
priate safety and health practices and determine the applica-
designed to allow for comparisons between different metal
bility of regulatory limitations prior to use.
backed glenoid locking mechanism designs, when tested under
2. Referenced Documents similar circumstances.
4.4 This test method may not be appropriate for all types of
2.1 ASTM Standards:
implant applications. The user is cautioned to consider the
E 4 Practices for Force Verification of Testing Machines
3 appropriateness of the method in view of the materials being
F 1378 Specification for Shoulder Prosthesis
tested and their potential application.
3. Terminology 4.5 In order for the test data on metal backed glenoid
components to be comparable, reproducible, and capable of
3.1 Definitions:
being correlated among laboratories, it is essential that uniform
3.1.1 articular insert—the polymeric prosthetic portion of a
procedures be established.
multiple piece glenoid component that articulates with the
humeral head.
5. Apparatus
3.1.2 “d”—offset distance from the edge of the glenoid
5.1 The test fixture shall be constructed so that the line of
backing locking mechanism to the centerline of the point of
load application is parallel to the intended axis of the implant
load application on the articular insert as shown in Fig. 1 and
(that is, inferior to superior or anterior to posterior).
Fig. 2.
3.1.3 glenoid backing—the metallic or composite material
6. Equipment
prosthetic portion of a multiple piece glenoid component that
6.1 The tests will be performed on either mechanical or
attaches to the scapula.
hydraulic load frames with adequate load capacity and that
meet the criteria of Practices E 4.
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
7. Sampling
F04.22 on Arthroplasty.
7.1 Aminimum of five samples with the load oriented in the
Current edition approved Sept. 10, 2003. Published October 2003. Originally
approved in 1997. Last previous edition approved in 1998 as F 1829 - 98. inferior to superior direction shall be tested per device.
Annual Book of ASTM Standards, Vol 03.01.
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.
F1829–98 (2003)
FIG. 1 Schematic of Static Glenoid Locking Strength Inferior to Superior Direction
FIG. 2 Schematic of Static Glenoid Locking Strength Anterior to Posterior Direction
7.2 Aminimum of five samples with the load oriented in the products. All manufacturing processes (including heat treat-
anterior to posterior direction shall be tested per device. ment) should be followed.
8.3 All components should be sterilized according to manu-
8. Sample and Test Specimen
facturer recommended specifications for clinical use, if this
8.1 All articular insert test components shall be representa-
process could affect the results.
tive of final manufactured implant quality products.
8.4 A new articular insert should be used for each test.
8.2 Glenoid backing test components may either be in the
form of the final implant or may be a simplified model with the
exact locking mechanism to be used on the final implant. The
materials and surface shall be representative of implant quality
F1829–98 (
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