ASTM WK70906

    Revision of F2193 - 18a Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

    (What is a Work Item?)

    Active Standard: F2193 - 18a

    Developed by Subcommittee: F04.25 | Committee F04 | Contact Staff Manager



    WK70906


    Keywords

    bend testing–plate; bend testing–rod; bend testing–screw; bend testing–surgical implants; fatigue test–plate; fatigue test–rod; fatigue test–screw; fatigue test–surgical implants; orthopedic medical device–plate; orthopedic medical device–rod; orthopedic medical device–screw; orthopedic spinal devices; performance; spinal arthrodesis; surgical devices; terminology; test methods–surgical implants;;

    Rationale

    We are balloting the ASTM Standard F2193 Standard Specifications and Test Methods for Components Used in Surgical Fixation of the Spinal Skeletal System section X2.3. Recall that the update from F2193-14 to F2193-18 changed the type of polyurethane bone foam use in A1.5.3.1 Driving Torque Requirements from Grade 40 to Grade 20. Unfortunately, the Appendix section X2.3 was not updated concomitantly and states a rationale for Grade 40 polyurethane bone foam, which is no longer used in this test. The goal of this ballot is to bring consistency between the rationale in X2.3 and the change from Grade 40 to Grade 20 in A1.5.3.1 that has already been implemented.

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    Work Item Status

    Date Initiated:
    12-05-2019

    Technical Contact:
    Alexander Gage

    Item:
    016

    Ballot:
    F04 (19-06)

    Status:
    At Society Review