ASTM F1829-23

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Designation: F1829 − 17 F1829 − 23
Standard Test Method for
Static Evaluation of Anatomic Glenoid Locking Mechanism
in Shear
This standard is issued under the fixed designation F1829; 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
1.1 This test method covers a method for determining the static shear disassembly force of modular anatomic glenoid components
used in anatomic total shoulder arthroplasty prostheses.
1.2 Although the methodology described does not replicate all physiological force conditions, it is a means of in vitro comparison
of modular anatomic glenoid component designs and the strength of the retention mechanism between the articular insert and
glenoid backing under the stated test conditions.
1.3 This test method covers modular glenoid components comprised of a separate articular insert and backing. The insert and
backing can be fabricated from any combination of the following materials: metal alloys, polymeric materials, composite materials.
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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 healthsafety, health, and environmental practices and determine
the applicability of regulatory limitations prior to use.
1.6 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
2. Referenced Documents
2.1 ASTM Standards:
E4 Practices for Force Calibration and Verification of Testing Machines
F1378 Specification for Shoulder Prostheses
F2028 Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
3. Terminology
3.1 Anatomic Total Shoulder Replacement (TSR) DefinitionsDefinitions:
This test method is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
Current edition approved Dec. 1, 2017March 1, 2023. Published January 2018March 2023. Originally approved in 1997. Last previous edition approved in 20162017 as
F1829 – 16.F1829 – 17. DOI: 10.1520/F1829-17.10.1520/F1829-23.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
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F1829 − 23
3.1.1 anatomic total shoulder arthroplasty system, n—shoulder implant system that has a concave glenoid component and a
convex humeral component design.
3.1.2 anatomic glenoid component, n—the concave prosthetic portion that replaces, in part or in total, the glenoid fossa of the
scapula and articulates with the natural humeral head or a prosthetic replacement.
3.1.3 glenoid backing, n—the metallic or composite material prosthetic portion of a multi-piece anatomic glenoid component that
attaches to the scapula.
3.1.4 glenoid liner, n—the polymeric prosthetic portion of a multiple piece multiple-piece anatomic glenoid component that
articulates with the humeral head.
3.2 Additional DefinitionsDefinitions:
3.2.1 collar, n—flange at the junction of the humeral neck and stem.
3.2.2 keel, (or pegs), n—single or multiple projections that provide resistance to translation or rotation of the glenoid component,
or both, by mating with cavities created in the glenoid fossa.
3.2.3 neck, n—segment connecting the head and the stem.
3.2.4 glenoid plane, n—in symmetrical anatomic glenoids, the glenoid plane is defined by joining the two articular edges; in planar
and asymmetric anatomic glenoids, it is defined by the back (medial) surface.
3.2.4.1 Discussion—
Although the glenoid fossa is not truly a planar structure, the terms plane of the glenoid and glenoid plane have both been used
in the scientific literature to describe the anatomic orientation of the glenoid.
3.2.5 humeral head, n—the bearing member that articulates with the glenoid.
3.2.6 humeral component, n—the prosthetic portion that replaces, in part or in total, the proximal humerus or humeral head and
articulates with the natural glenoid fossa or a prosthetic replacement.
3.2.7 humeral stem, n—segment intended for insertion within the humeral medullary canal.
3.3 Definitions of Terms Specific to This Standard:
3.3.1 “d”, n—offset distance from the edge of the glenoid backing locking mechanism to the centerline of the point of force
application on the articular insert as shown in Fig. 1Figs. 1 and 2 and . Fig. 2.
4. Significance and Use
4.1 This test method can be used to describe the effects of materials, manufacturing, and design variables on the performance of
metal or composite-backed anatomic glenoid prostheses’ locking mechanisms to resist static shear loading.
4.2 The glenoid component is used in shoulder replacements and should conform to the criteria specified in Specification F1378.
4.3 The loading of metal or composite-backed anatomic glenoid prostheses in vivo will, in general, differ from the loading defined
in this test method. The results obtained here cannot be used to directly predict in vivo performance. However, this test method
is designed to allow for comparisons between different metal or composite-backed anatomic glenoid locking mechanism designs,
when tested under similar circumstances.the same testing conditions.
4.4 This test method may not be appropriate for all types of implant applications. The user is cautioned to consider the
appropriateness of the method in view of the materials being tested and their potential application.
F1829 − 23
FIG. 1 Schematic of Static Glenoid Locking Strength Inferior-to-Superior Direction
FIG. 2 Schematic of Static Glenoid Locking Strength Anterior-to-Posterior Direction
4.5 In order for the test data on metal or composite-backed anatomic glenoid components to be comparable, reproducible, and
capable of being correlated among laboratories, it is essential that uniform procedures be established.
5. Apparatus
5.1 The test fixture shall be constructed so that the line of load application is parallel to the intended axis of the implant (that is,
inferior to superior or anterior to posterior).
6. Equipment
6.1 The tests will be performed on either mechanical or hydraulic load frames with adequate load capacity and that meet the
criteri
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