Standardization News

A proposed ASTM International standard aims to improve quality of life for patients who have had total knee replacement surgery due to conditions such as osteoarthritis.

The proposed standard (WK49175, Practice for Finite Element Analysis (FEA) of Metallic Orthopedic Total Knee Femoral Components Under Closing Conditions) outlines how to evaluate the strength of knee replacement femoral components using finite element analysis, a computer simulation technique that has been historically used to evaluate the structural integrity of engineering designs.

Specifically, the standard will establish requirements and considerations for developing finite element analysis models to evaluate metallic orthopedic total knee femoral component designs. This will allow manufacturers and designers to establish the worst-case femoral component size (in terms of stresses and strains) to limit the amount of physical testing requirements. This, in turn, supports the regulatory submission and review process.

In addition to patients themselves, beneficiaries of this standard could include medical device manufacturers, global regulatory body reviewers, university researchers and mechanical test laboratories.

Subcommittee F04.22 on Arthroplasty invites involvement from all interested parties as it develops this standard. The subcommittee is particularly interested in expanding the number of orthopedic industry and academic partners who are interested in developing clinically relevant mechanical test models and their computational simulation analogs.

CONTACT Technical Information: Walter Schmidt, Stryker Orthopaedics • Mahwah, N.J. • tel +1.201.831.5386 | ASTM Staff: Pat Picariello • tel +1.610.832.9720 | Upcoming Meeting: Nov. 17-20 • November Committee Week • Tampa, Fla.