| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
065
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Date of Entry 12/22/2025
|
|
FR Recognition Number
|
11-433
|
| Standard | |
ASTM F2028-25a
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening |
|
Scope/Abstract1.1 These test methods measure how much a prosthetic anatomic glenoid component rocks or pivots following dynamic displacement of the humeral head between opposing glenoid rims (e.g., superior-inferior or anterior-posterior). Motion of the anatomic glenoid component is quantified by measuring displacement opposite each loaded rim after dynamic rocking. Similarly, these test methods measure how much a prosthetic reverse glenoid baseplate rocks or pivots following dynamic articulation of the reverse glenoid component with a mating humeral liner. Motion of the reverse glenoid baseplate is quantified by measuring displacement before and after dynamic articulation.
1.2 These test methods cover shoulder replacement designs with monolithic or modular anatomic glenoid components for cemented fixation as well as reverse glenoid components for uncemented fixation with the use of screws.
1.3 This test method is intended to be used to compare or rank device designs. |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
- Subclause 16.2.4 Procedure (number of cycles)
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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.
This standard is recognized in part because:
The number of cycles in subclause 16.2.4 is not aligned with current trends in usage and patient populations described in published literature. See references #2 and #3 below. |
|
Transition Period
| FDA recognition of ASTM F2028-17 [Rec# 11-330] will be superseded by recognition of ASTM F2028-25a [Rec# 11-433]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-330] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 11-330] will not be accepted. |
|
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
|
Class 3
|
KWR
|
| §888.3650 |
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
|
Class 2
|
KWT
|
| §888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
|
Class 2
|
KWS
|
| §888.3660 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
|
Class 2
|
PAO
|
| §888.3660 |
Shoulder Prosthesis, Reverse Configuration
|
Class 2
|
PHX
|
| §888.3670 |
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
|
Class 2
|
MBF
|
| §888.3680 |
Metallic Cemented Glenoid Hemi-Shoulder Prosthesis
|
Class 3
|
KYM
|
|
Relevant FDA Guidance and/or Supportive Publications*
1. Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis - Class II Special Controls Guidance for Industry and FDA Staff, issued October 2000.
2. Langohr GDG, Haverstock JP, Johnson JA, Athwal GS. Comparing daily shoulder motion and frequency after anatomic and reverse shoulder arthroplasty. J Shoulder Elbow Surg. 2018 Feb;27(2):325-332.
3. Leathers MP, Ialenti MN, Feeley BT, Zhang AL, Ma CB. Do younger patients have better results after reverse total shoulder arthroplasty? J Shoulder Elbow Surg. 2018 Jun;27(6S):S24-S28.
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 Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
