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Work Item

ASTM WK78557

New Test Method for Cyclic Fatigue Testing of Posterior-Stabilized Tibial Bearing Components

1. Scope
1.1 This test method covers a procedure for the shear and bending fatigue testing of the tibial posts of posterior-stabilized tibial bearing components. This test method covers the procedures for the performance of fatigue tests on posterior-stabilized components using a cyclic, constant-amplitude force. 1.2 This test method is intended to provide useful, consistent, and reproducible information about the fatigue performance of tibial posts of posterior-stabilized tibial bearing components.
Keywords
Total Knee Replacement; TKR, Total Knee Arthroplasty; TKA, fatigue, Posterior-Stabilized; PS; Tibial Post; Tibial Spine; Tibial Insert
Rationale

Fatigue testing of the tibial post is recommended in Section 7 D of Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA. However, no such standard exists to guide a user on testing. This method will serve to help standardize testing and reduce variability in test results similar to ASTM F1800.

Details

Developed by Subcommittee: F04.22

Committee: F04

Staff Manager: Kate Chalfin

Work Item Status

Date Initiated: 10-12-2021

Technical Contact: Christian Kaddick

Item: 000

Ballot: 

Status: 

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