Active Standard ASTM F2028 | Developed by Subcommittee: F04.22
Book of Standards Volume: 13.01
Historical (view previous versions of standard)
Significance and Use
5.1 This test method is intended to investigate the resistance of a glenoid component to loosening. Glenoid loosening is the most common clinical complication in total shoulder arthroplasty (see X1.1). The method assumes that loosening occurs because of edge loading, often called the rocking-horse phenomenon.
5.2 This test method can be used both to detect potential problems and to compare design features. Factors affecting loosening performance include articular geometry, flange geometry, materials, fixation design, bone quality, and surgical technique.
1.1 These test methods measure how much a prosthetic glenoid component rocks or pivots following cyclic displacement of the humeral head to opposing glenoid rims (for example, superior-inferior or anterior-posterior). Performance is judged by the tensile displacement opposite each loaded rim after dynamic rocking.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
E4 Practices for Force Verification of Testing Machines
F1378 Specification for Shoulder Prostheses
F1839 Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)