ASTM F1829-17

Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear

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.  
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.  
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.
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 health 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.

General Information

• Status: Historical
• Publication Date: 30-Nov-2017
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: F1829 − 17
Standard Test Method for
Static Evaluation of Anatomic Glenoid Locking Mechanism
1
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 2. Referenced Documents
2
1.1 This test method covers a method for determining the 2.1 ASTM Standards:
static shear disassembly force of modular anatomic glenoid E4 Practices for Force Verification of Testing Machines
components used in anatomic total shoulder arthroplasty pros- F1378 Specification for Shoulder Prostheses
theses. F2028 Test Methods for Dynamic Evaluation of Glenoid
Loosening or Disassociation
1.2 Although the methodology described does not replicate
all physiological force conditions, it is a means of in vitro
3. Terminology
comparison of modular anatomic glenoid component designs
3.1 Anatomic Total Shoulder Replacement (TSR) Definitions
and the strength of the retention mechanism between the
3.1.1 anatomic total shoulder arthroplasty system,
articular insert and glenoid backing under the stated test
n—shoulder implant system that has a concave glenoid com-
conditions.
ponent and a convex humeral component design.
1.3 This test method covers modular glenoid components
3.1.2 anatomic glenoid component, n—the concave pros-
comprised of a separate articular insert and backing. The insert
thetic portion that replaces, in part or in total, the glenoid fossa
and backing can be fabricated from any combination of the
of the scapula and articulates with the natural humeral head or
following materials: metal alloys, polymeric materials, com-
a prosthetic replacement.
posite materials.
3.1.3 glenoid backing, n—the metallic or composite mate-
1.4 The values stated in SI units are to be regarded as
rial prosthetic portion of a multi-piece anatomic glenoid
standard. No other units of measurement are included in this
component that attaches to the scapula.
standard.
3.1.4 glenoid liner, n—the polymeric prosthetic portion of a
1.5 This standard does not purport to address all of the
multiple piece anatomic glenoid component that articulates
safety concerns, if any, associated with its use. It is the
with the humeral head.
responsibility of the user of this standard to establish appro-
3.2 Additional Definitions
priate safety and health practices and determine the applica-
3.2.1 collar, n—flange at the junction of the humeral neck
bility of regulatory limitations prior to use.
and stem.
1.6 This international standard was developed in accor-
dance with internationally recognized principles on standard- 3.2.2 keel, (or pegs), n—single or multiple projections that
provide resistance to translation or rotation of the glenoid
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom- component, or both, by mating with cavities created in the
glenoid fossa.
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
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;
1
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
2
F04.22 on Arthroplasty. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Dec. 1, 2017. Published January 2018. Originally contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
approved in 1997. Last previous edition approved in 2016 as F1829 – 16. DOI: Standards volume information, refer to the standard’s Document Summary page on
10.1520/F1829-17. the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1829 − 17
in planar and asymmetric anatomic glenoids, it is defined by between different metal or composite-backed anatomic glenoid
the back (medial) surface. locking mechanism designs, when tested under similar circum-
stances.
3.2.4.1 Discussion—Although the glenoid fossa is not truly
4.4 This test method may not be appropriate for all types of
a planar structure, the terms plane of the glenoid and glenoid
implant applications. The user is cautioned to consider the
plane have both been used in the scientific literature to describe
appropriateness of the method in view of the materials being
the anatomic orientation of the glenoid.
te
...

This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F1829 − 16 F1829 − 17
Standard Test Method for
Static Evaluation of Anatomic Glenoid Locking Mechanism
1
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 health 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
2.1 ASTM Standards:
E4 Practices for Force Verification of Testing Machines
F1378 Specification for Shoulder Prostheses
F2028 Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
3. Terminology
3.1 Definitions: Anatomic Total Shoulder Replacement (TSR) Definitions
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 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 anatomic glenoid component that articulates with the
humeral head.
3.2 Additional Definitions
3.2.1 collar, n—flange at the junction of the humeral neck and stem.
1
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 March 1, 2016Dec. 1, 2017. Published April 2016January 2018. Originally approved in 1997. Last previous edition approved in 20092016 as
F1829 – 98 (2009).F1829 – 16. DOI: 10.1520/F1829-16.10.1520/F1829-17.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1829 − 17
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 anatomi
...