| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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061
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Date of Entry 12/18/2023
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FR Recognition Number
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11-405
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| Standard | |
ASTM F1829-23
Standard Test Method for Static Evaluation of Anatomic Glenoid Locking Mechanism in Shear |
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Scope/Abstract1.1 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. |
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| Extent of Recognition
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Rationale for Recognition
| This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies |
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Transition Period
| FDA recognition of ASTM F1829-17 [Rec# 11-334] will be superseded by recognition of ASTM F1829-23 [Rec# 11-405]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-334] until December 21, 2025. After this transition period, declarations of conformity to [Rec# 11-334] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Regulation Number |
Device Name |
Device Class |
Product Code |
| §888.3640 |
Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented
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Class 3
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KWR
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| §888.3650 |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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Class 2
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KWT
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| §888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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Class 2
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KWS
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| §888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
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Class 2
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PAO
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| §888.3660 |
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
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Class 2
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PKC
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| §888.3660 |
Total Shoulder Arthroplasty System
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Class 2
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QHQ
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| §888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
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Class 2
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MBF
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| §888.3680 |
Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
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Class 3
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KYM
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Relevant FDA Guidance and/or Supportive Publications*
1. Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis - Guidance for Industry and FDA Staff, issued October 2000.
2. Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement, issued April 1994.
3. Guidance for Industry and for FDA Reviewers/Staff - Guidance for Industry on the Testing of Metallic Plasma Sprayed Coatings on Orthopedic Implants to Support Reconsideration of Postmarket Surveillance Requirements, issued February 2000.
4. Guidance Document - 510(k) Information Needed for Hydroxyapatite Coated Orthopedic Implants, issued February 1997.
5. Guidance Document for Testing Non-Articulating, "Mechanically Locked", Modular Implant Components, issued May 1995.
6. Characterization of Ultrahigh Molecular Weight Polyethylene (UHMWPE) Used in Orthopedic Devices - Guidance for Industry and Food and Drug Administration Staff, issued April 2019.
7. Reporting of Computational Modeling Studies in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff, issued September 2016.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contact
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
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