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Scope

1.1 This test method describes a laboratory method for evaluating the potential for mobile bearing knee tibial baseplate/bearing disassociation under repeated forces.

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.

1.4 The values stated in SI units are regarded as standard.

1.5 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Significance and Use

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.

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.

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.

Keywords

Knee replacement prosthesis; Medical devices/equipment; Surgical implants; Tibial components/dimensions/testing; ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

To find similar documents by ASTM Volume:

13.02 (Emergency Medical Services; Search and Rescue; Anesthetic and Respiratory Equipment)

To find similar documents by classification:

11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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