| Part B: Supplementary Information Sheet (SIS) |
|
FR Recognition List Number
|
055
|
Date of Entry 12/21/2020
|
|
FR Recognition Number
|
11-330
|
| Standard | |
ASTM F2028-17
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation |
|
Scope/Abstract1.1 These test methods measure how much a prosthetic anatomic glenoid component rocks or pivots following cyclic displacement of the humeral head to opposing glenoid rims (for example, superior-inferior or anterior-posterior). Motion is quantified by the tensile displacement opposite each loaded rim after dynamic rocking. Similarly, these test methods measure how much a prosthetic reverse glenoid component rocks or pivots following cyclic articulation with a mating humeral liner. Motion is quantified by the magnitude of displacement measured before and after cyclic loading.
1.2 The same setup can be used to test the locking mechanisms of modular glenoid components, for example, disassociation of both anatomic and reverse shoulder components.
1.3 These test methods cover shoulder replacement designs with monolithic or modular glenoid components for cemented fixation as well as reverse glenoid components for uncemented fixation. |
|
Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
- Subclause 24.2.4 Procedure (number of cycles)
- Subclause X2.9 in APPENDIX X2 Rationale for Reverse Shoulder Glenoid Loosening/Disassociation Test (number of cycles)
|
|
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:
In regard to Procedure Subclause 24.2.4 (number of cycles) and Subclause X2.9 in APPENDIX X2 Rationale for Reverse Shoulder Glenoid Loosening/Disassociation Test: Current trends in usage and patient populations, such as discussed in references #2 and #3 below, provide medical device manufacturers considerations to support an appropriate number of cycles. |
|
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. |
|
| FDA Technical Contact
|
| Standards Development Organization
|
| FDA Specialty Task Group (STG)
|
| *These are provided as examples and others may be applicable. |
|
|
