Work Item
ASTM WK78557

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

1. Scope

The scope of the Committee shall be the development of standardized nomenclature and definitions of terms, test methods, recommended practices, guides, specifications and performance standards for medical and surgical materials and devices. The Committee will encourage research in this field and sponsor symposia, workshops and publications to facilitate the development of such standards. The Committee will promote liaison with other ASTM Committees and other organizations with mutual interests.

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: