ASTM F2028-14

Standard Organization:

ASTM F2028-14
Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation

Recognition Date2015-01-27
Recognition List038
Recognition Number11-284
Extent Complete standard
Standards Orgs ASTM ASTM International http://www.astm.org/
STG Orthopedic
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§888.3680 Metallic Cemented Glenoid Hemi-Shoulder Prosthesis Class 3 KYM
§888.3670 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Class 2 MBF
§888.3660 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented Class 2 PAO
§888.3660 Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Class 2 KWS
§888.3650 Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Class 2 KWT
§888.3640 Prosthesis, Shoulder, Constrained, Metal/Metal Or Metal/Polymer Cemented Class 3 KWR

FDA Guidance:

Guidance for Industry and FDA Staff - Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis, October 31, 2000

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