ASTM F1781-21

Standard Specification for Elastomeric Flexible Hinge Finger Total Joint Implants

ABSTRACT
This specification covers the biocompatibility and other performance requirements, and associated test methods for elastomeric flexible hinge finger total joint implants, used with and without metal grommets in the reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints. This specification excludes those implants that do not have an across-the-joint elastomeric linkage, and is limited to implants made from one material in a single one-step molding procedure.
SCOPE
1.1 This specification covers elastomeric flexible hinge finger total joint implants, used with and without metal grommets, in the reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints.  
1.2 This specification excludes those implants that do not have an across-the-joint elastomeric linkage. This specification is limited to implants made from one material in a single, one-step molding procedure.  
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.4 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: Published
• Publication Date: 31-Aug-2021
• 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)

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.
Designation: F1781 −21
Standard Specification for
1
Elastomeric Flexible Hinge Finger Total Joint Implants
This standard is issued under the fixed designation F1781; 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 F86 Practice for Surface Preparation and Marking of Metal-
lic Surgical Implants
1.1 This specification covers elastomeric flexible hinge
F601 Practice for Fluorescent Penetrant Inspection of Me-
finger total joint implants, used with and without metal
tallic Surgical Implants
grommets, in the reconstruction of the metacarpophalangeal
F748 PracticeforSelectingGenericBiologicalTestMethods
(MCP) and proximal interphalangeal (PIP) joints.
for Materials and Devices
1.2 This specification excludes those implants that do not
F981 Practice for Assessment of Compatibility of Biomate-
have an across-the-joint elastomeric linkage.This specification
rials for Surgical Implants with Respect to Effect of
is limited to implants made from one material in a single,
Materials on Muscle and Insertion into Bone
one-step molding procedure.
F983 Practice for Permanent Marking of Orthopaedic Im-
1.3 The values stated in SI units are to be regarded as plant Components
F2038 GuideforSiliconeElastomers,Gels,andFoamsUsed
standard. No other units of measurement are included in this
standard. in Medical Applications Part I—Formulations and Un-
cured Materials
1.4 This international standard was developed in accor-
F2042 GuideforSiliconeElastomers,Gels,andFoamsUsed
dance with internationally recognized principles on standard-
in Medical Applications Part II—Crosslinking and Fabri-
ization established in the Decision on Principles for the
cation
Development of International Standards, Guides and Recom-
F2503 Practice for Marking Medical Devices and Other
mendations issued by the World Trade Organization Technical
Items for Safety in the Magnetic Resonance Environment
Barriers to Trade (TBT) Committee.
F2943 Guide for Presentation of End User Labeling Infor-
mation for Musculoskeletal Implants
2. Referenced Documents
3
2.2 Government Standards:
2
2.1 ASTM Standards:
21 CFR 820 Quality System Regulation
D412 Test Methods forVulcanized Rubber andThermoplas-
21 CFR 888.6 Degree of Constraint
tic Elastomers—Tension
MIL STD 177A Rubber Products, Terms for Visible De-
D624 Test Method for Tear Strength of Conventional Vul-
3
fects
canized Rubber and Thermoplastic Elastomers
4
2.3 ISO Standard:
D813 TestMethodforRubberDeterioration—CrackGrowth
ISO 10993-1 Biological Evaluation of Medical Devices—
D1052 Test Method for Measuring Rubber Deterioration—
Part 1: Evaluation and testing within a risk management
Cut Growth Using Ross Flexing Apparatus
process
D2240 Test Method for Rubber Property—Durometer Hard-
ness
3. Significance and Use
F67 Specification for Unalloyed Titanium, for Surgical Im-
3.1 The prostheses described in this specification are in-
plant Applications (UNS R50250, UNS R50400, UNS
tended for use in the proximal interphalangeal (PIP) and
R50550, UNS R50700)
metacarpophalangeal (MCP) joints.
4. Classification
1
This specification is under the jurisdiction of ASTM Committee F04 on
4.1 Constrained—A constrained joint prosthesis is used for
Medical and Surgical Materials and Devices and is the direct responsibility of
Subcommittee F04.22 on Arthroplasty.
joint replacement and prevents dislocation of the prosthesis in
Current edition approved Sept. 1, 2021. Published September 2021. Originally
approved in 1997. Last previous edition approved in 2015 as F1781 – 15. DOI:
3
10.1520/F1781-21. AvailablefromU.S.GovernmentPrintingOfficeSuperintendentofDocuments,
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM www.access.gpo.gov.
4
Standards volume information, refer to the standard’s Document Summary page on Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
the ASTM website. 4th Floor, New York, NY 10036, http://www.ansi.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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F1781 − 21
5
more than one anatomic plane and consists of either a single, hinge have been reported (1-3). The fatigue characteristics of
flexible, across-the-joint component or more t
...

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: F1781 − 15 F1781 − 21
Standard Specification for
1
Elastomeric Flexible Hinge Finger Total Joint Implants
This standard is issued under the fixed designation F1781; 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 specification covers elastomeric flexible hinge finger total joint implants, used with and without metal grommets, in the
reconstruction of the metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joints.
1.2 This specification excludes those implants that do not have an across-the-joint elastomeric linkage. TheThis specification is
limited to implants made from one material in a single, one-step molding procedure.
1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.4 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:
D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
D624 Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D813 Test Method for Rubber Deterioration—Crack Growth
D1052 Test Method for Measuring Rubber Deterioration—Cut Growth Using Ross Flexing Apparatus
D2240 Test Method for Rubber Property—Durometer Hardness
F67 Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS
R50700)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F601 Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Insertion into Bone
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F2038 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part I—Formulations and Uncured
Materials
F2042 Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications Part II—Crosslinking and Fabrication
F2503 Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
1
This specification 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 Oct. 1, 2015Sept. 1, 2021. Published December 2015September 2021. Originally approved in 1997. Last previous edition approved in 20092015
as F1781 – 03 (2009).F1781 – 15. DOI: 10.1520/F1781-15.10.1520/F1781-21.
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 ----------------------
F1781 − 21
F2943 Guide for Presentation of End User Labeling Information for Musculoskeletal Implants
3
2.2 Government Standards:
21 CFR 820 Good Manufacturing Practices for Medical DevicesQuality System Regulation
21 CFR 888.6 Degree of Constraint
3
MIL STD 177A Rubber Products, Terms for Visible Defects
4
2.3 ISO Standard:
ISO 10993-1 Biological EvaluationsEvaluation of Medical Devices — Part Devices—Part 1: Evaluation and testing within a risk
management process
3. Significance and Use
3.1 The prostheses described in this specification are intended for use in the proximal interphalangeal (PIP) and metacarpopha-
langeal (MCP) joints.
4. Classification
4.1 Constrained—A constrained joint prosthesis is used for joint replacement and prevents dislocation of the prosthesis in more
than one anatomicalanatomic plane and consists of either a single, flexible, across-the-joint component,component or more than
one component linked together or affined.affined (21 CFR 888
...