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.

The title and scope are in draft form and are under development within this ASTM Committee.

Details

Developed by Subcommittee: F04.22

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 10-12-2021

Technical Contact: Michael Lowry

Item: 000

Ballot:

Status: