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Significance and Use
3.1 This test method includes the use of static and fatigue shear and bending force conditions to evaluate the bearing retention mechanism of a mobile bearing knee design and its ability to prevent disassociation.
3.2 In general, disassociation does not occur during activities where the contact locations are within the boundaries of the bearing surfaces. Disassociation is most likely to occur with forces at the edges of the bearing component or with large AP shear forces on a posterior stabilized knee tibial component post. Extreme bearing rotation, bone/bearing impingement, severe varus or valgus moments, high flexion or any combination of the above can increase the likelihood of disassociation.
3.3 The test method described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism. With modification, the test can be applied to a unicompartmental mobile bearing knee with a bearing retention mechanism.
1.2 The test described is applicable to any bicompartmental mobile bearing knee with a bearing retention mechanism. With modification, the test can be applied to a unicompartmental mobile bearing knee with a bearing retention mechanism.
1.3 Although the methodology described does not replicate all physiological force conditions, it is a means of in vitro comparison of mobile bearing knee designs and the strength of the bearing retention mechanism between the tibial baseplate and bearing components under the stated test conditions.
2. Referenced Documents (purchase separately) The documents listed below are referenced within the subject standard but are not provided as part of the standard.
F1223 Test Method for Determination of Total Knee Replacement Constraint
ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)
UNSPSC Code 42321805(Tibial baseplate)