ASTM F1378-05(2010)

This document is not anASTM standard and is intended only to provide the user of anASTM 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:F1378–05 Designation: F1378 – 05 (Reapproved 2010)
Standard Specification for
Shoulder Prostheses
This standard is issued under the fixed designation F1378; 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 shoulder prostheses for total or hemiarthroplasty used to provide functioning articulation by
employing glenoid and humeral components.
1.2 Devices for custom applications are not covered by this specification. Modular prostheses are included in this specification.
1.3 The values stated in SI are to be regarded as the standard. The inch-pound units given in parentheses are for information
only.
2. Referenced Documents
2.1 ASTM Standards:
F75 Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS
R30075)
F86 Practice for Surface Preparation and Marking of Metallic Surgical Implants
F90 Specification for Wrought Cobalt-20Chromium-15Tungsten-10Nickel Alloy for Surgical Implant Applications (UNS
R30605)
F136 Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant
Applications (UNS R56401)
F138 Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants
(UNS S31673)
F562 Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications
(UNS R30035)
F563 Specification for Wrought Cobalt-20Nickel-20Chromium-3.5Molybdenum-3.5Tungsten-5IronAlloy for Surgical Implant
Applications (UNS R30563)
F603 Specification for High-Purity Dense Aluminum Oxide for Medical Application
F648 Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants
F745 Specification for 18Chromium-12.5Nickel-2.5Molybdenum Stainless Steel for Cast and Solution-Annealed Surgical
Implant Applications
F746 Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F799 Specification for Cobalt-28Chromium-6Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538,
R31539)
F981 Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on
Muscle and Bone
F983 Practice for Permanent Marking of Orthopaedic Implant Components
F1044 Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
F1108 Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406)
F1147 Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings
F1537 Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS
R31538, and UNS R31539)
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, 2005. Published October 2005. Originally approved in 1992. Last previous edition approved in 2004 as F1378–04. DOI:
10.1520/F1378-05.
Current edition approved Dec. 15, 2010. Published February 2011. Originally approved in 1992. Last previous edition approved in 2005 as F1378 – 05. DOI:
10.1520/F1378-05R10.
For referencedASTM standards, visit theASTM website, www.astm.org, or contactASTM 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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F1378 – 05 (2010)
F1829 Test Method for Static Evaluation of Glenoid Locking Mechanism in Shear
F2028 Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation
2.2 ANSI Standard:
ASME B46.1–1995
3. Terminology
3.1 Definitions of Terms Specific to This Standard:
3.1.1 collar—flange at the junction of the neck and stem.
3.1.2 glenoid component—the 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 head—bearing member for articulation with the glenoid.
3.1.4 humeral component—the prosthetic portion that replaces, in part or in toto, the proximal humerus or humeral head and
articulates with the natural glenoid fossa or a prosthetic replacement.
3.1.5 keel, (or pegs)—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.
3.1.6 neck—segment connecting the head and the stem.
3.1.7 reverse design shoulder implants—implants that have a ball-shaped glenoid component and a concave humeral design.
3.1.8 stem—segment intended for insertion within the humeral medullary canal.
4. Classification
4.1 Constrained—A constrained joint prosthesis is used for joint replacement and resists dislocation of the prosthesis in more
than one anatomical plane and consists of either a single, flexible, across-the-joint component or more than one component linked
together or affined.
4.2 Partially Constrained—A semi-constrained joint prosthesis is used for partial or total joint replacement and limits
translation and rotation of the prosthesis in one or more planes via the geometry of its articulating surfaces. It has no
across-the-joint linkages.
4.3 Unconstrained—An unconstrained joint prosthesis is used for partial or total joint replacement and restricts minimally
prosthesis movement in one or more planes. Its components have no across-the-joint linkage.
5. Materials and Manufacture
5.1 The choice of materials is understood to be a necessary but not sufficient ensurance of function of the device made from
them. All devices conforming to this specification shall be fabricated from materials, with adequate mechanical strength and
durability, corrosion resistance, and biocompatibility.
5.1.1 Mechanical Strength—Various components of shoulder prostheses have been successfully fabricated from the following
materials. However, not all of these materials may possess sufficient mechanical strength for critical highly-stressed components.
See Specifications F75, F90, F136, F138, F562, F563 (nonbearing use only), F603, F648, F745, F799, F1108, and F1537.
5.1.2 Corrosion Resistance—Materials with limited or no history of successful use for orthopedic implant application mustshall
be determined to exhibit corrosion resistance equal to or better than one of the materials listed in 5.1.1 when tested in accordance
with Test Method F746.
5.1.3 Biocompatibility—Materials with limited or no history of successful use for orthopedic implant application must be
determined to exhibit acceptable biological response equal to or better than one of the materials listed in 5.1.1 when tested in
accordance with Practices F748 and F981.
6. Performance Requirements
6.1 Wear of Alternative Materials—It is important to understand the wear performance for articulating surfaces. Any new or
different material should not exceed the wear rates of the following material couple when tested under physiological conditions.
The current standard wear couple is CoCrMo alloy (Specification F75) against ultra high molecular weight polyethylene
(Specification F648), both having prosthetic quality surface finishes according toin accordance with 8.2.
NOTE 1—In situations where the pin-on-flat test may not be considered appropriate, other test methods may be considered.
6.2 Range of Motion of Shoulder Prosthesis Prior to Implantation—Flexion shall be equal to or greater than 90°. Abduction
shall be equal to or greater than 90°. Internal rotation shall be equal to or greater than 90°. External rotation shall be equal to or
greater than 45°. Extension shall be equal to or greater than 45°.
6.3 Porous metal coatings shall be tested according to Test Method F1044 (shear strength) and Test Method F1147 (tensile
strength).
6.4 Guidelines for In-Vitro Laboratory Testing:
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036.
F1378 – 05 (2010)
6.4.1 Implanttestingshouldreflectcurrentclinicalfailuresa
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