ASTM F1829-16

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.

General Information

• Status: Historical
• Publication Date: 29-Feb-2016
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.22 - Arthroplasty

Relations

• Replaces: ASTM F1829-98(2009) - Standard Test Method for Static Evaluation of the Glenoid Locking Mechanism in Shear
• Effective Date: 01-Mar-2016
• Referred By: ASTM F1378-18e1 - Standard Specification for Shoulder Prostheses
• Effective Date: 01-Mar-2016

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 − 16
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 3. Terminology
1.1 This test method covers a method for determining the 3.1 Definitions:
static shear disassembly force of modular anatomic glenoid 3.1.1 anatomic total shoulder arthroplasty system,
components used in anatomic total shoulder arthroplasty pros- n—shoulder implant system that has a concave glenoid com-
theses. ponent and a convex humeral component design.
3.1.2 glenoid component, n—the prosthetic portion that
1.2 Although the methodology described does not replicate
replaces the glenoid fossa of the scapula and articulates with
all physiological force conditions, it is a means of in vitro
the natural humeral head or a prosthetic replacement.
comparison of modular anatomic glenoid component designs
and the strength of the retention mechanism between the
3.2 Definitions of Terms Specific to This Standard:
articular insert and glenoid backing under the stated test
3.2.1 articular insert, n—the concave prosthetic portion of a
conditions.
multi-piece glenoid component that articulates with the hu-
meral head. This articular insert is most often polymeric.
1.3 This test method covers modular glenoid components
comprised of a separate articular insert and backing. The insert
3.2.2 “d”, n—offset distance from the edge of the glenoid
and backing can be fabricated from any combination of the
backing locking mechanism to the centerline of the point of
following materials: metal alloys, polymeric materials, com-
load application on the articular insert as shown in Fig. 1 and
posite materials.
Fig. 2.
1.4 The values stated in SI units are to be regarded as
3.2.3 glenoid backing, n—the metallic or composite mate-
standard. No other units of measurement are included in this
rial prosthetic portion of a multiple piece glenoid component
standard.
that attaches to the scapula.
1.5 This standard does not purport to address all of the
4. Significance and Use
safety concerns, if any, associated with its use. It is the
responsibility of the user of this standard to establish appro-
4.1 This test method can be used to describe the effects of
priate safety and health practices and determine the applica-
materials, manufacturing, and design variables on the perfor-
bility of regulatory limitations prior to use.
mance of metal or composite-backed anatomic glenoid pros-
theses’ locking mechanisms to resist static shear loading.
2. Referenced Documents
4.2 The glenoid component is used in shoulder replace-
2
2.1 ASTM Standards:
ments and should conform to the criteria specified in Specifi-
E4 Practices for Force Verification of Testing Machines
cation F1378.
F1378 Specification for Shoulder Prostheses
4.3 The loading of metal or composite-backed anatomic
F2028 Test Methods for Dynamic Evaluation of Glenoid
glenoid prostheses in vivo will, in general, differ from the
Loosening or Disassociation
loading defined in this test method. The results obtained here
cannot be used to directly predict in vivo performance.
However,thistestmethodisdesignedtoallowforcomparisons
1
This test method is under the jurisdiction ofASTM Committee F04 on Medical
between different metal or composite-backed anatomic glenoid
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.22 on Arthroplasty.
locking mechanism designs, when tested under similar circum-
Current edition approved March 1, 2016. Published April 2016. Originally
stances.
approved in 1997. Last previous edition approved in 2009 as F1829 – 98 (2009).
DOI: 10.1520/F1829-16.
4.4 This test method may not be appropriate for all types of
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
implant applications. The user is cautioned to consider the
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
appropriateness of the method in view of the materials being
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. tested and their potential application.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F1829 − 16
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
...

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 − 98 (Reapproved 2009) F1829 − 16
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 shoulder prostheses. It is intended to be used as a design validation and for comparison with other 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.
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:
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 glenoid component, n—the prosthetic portion that replaces the glenoid fossa of the scapula and articulates with the natural
humeral head or a prosthetic replacement.
3.2 Definitions:Definitions of Terms Specific to This Standard:
3.2.1 articular insert—insert, n—the polymericconcave prosthetic portion of a multiple piece multi-piece glenoid component
that articulates with the humeral head. This articular insert is most often polymeric.
3.2.2 “d”—“d”, n—offset distance from the edge of the glenoid backing locking mechanism to the centerline of the point of
load application on the articular insert as shown in Fig. 1 and Fig. 2.
3.2.3 glenoid backing—backing, n—the metallic or composite material prosthetic portion of a multiple piece glenoid component
that attaches to the scapula.
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 Feb. 1, 2009March 1, 2016. Published March 2009April 2016. Originally approved in 1997. Last previous edition approved in 20032009 as
F1829 – 98 (2009).(2003). DOI: 10.1520/F1829-98R09.10.1520/F1829-16.
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 − 16
FIG. 1 Schematic of Static Glenoid Locking Strength Inferior-to-Superior Direction
FIG. 2 Schematic of Static Glenoid Locking Strength Anterior-to-Posterior Direction
3.1.4 glenoid component—the prosthetic portion that replaces the glenoid fossa of the scapula and articulates with the natural
humeral head or a prosthetic replacement.
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-backed glenoid prosthesesmetal 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 Specifica
...