Work Item
ASTM WK68696

New Test Method for Intra-operative Impaction Durability of Intervertebral Body Fusion Devices

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

Cage, IBFD, Fracture, Insertion

Rationale

This standard will provide a test method for manufacturers to assess the ability of their intervertebral body fusion device/inserter instrument assembly to withstand expected impact loading often applied during surgical implantation. Numerous adverse events reporting cage/instrument fracture during surgical implantation have been reported in this device area. The method will provide an ability to compare performance between intervertebral body fusion device/instrument designs.

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

Details

Developed by Subcommittee: F04.25

Committee: F04

Staff Manager: Kathleen Chalfin

Work Item Status

Date Initiated: 06-14-2019

Technical Contact: Jonathan Peck

Item: 001

Ballot: F04.25 (20-01)

Status: Will Reballot Item

Item: 001

Ballot: F04.25 (21-02)

Status: Will Reballot Item

Item: 001

Ballot: F04.25 (21-04)

Status: Negative Votes Need Resolution