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ASTM Medical and Surgical Materials Committee Developing Proposed Standard for Unicondylar Knee Joint Replacements


A proposed new ASTM International standard will cover fatigue testing of metallic tibial trays, which are components used in partial knee joint replacement. ASTM WK45235, Practice for Cyclic Fatigue Testing of Metal Tibial Tray Components of Unicondylar Knee Joint Replacements, is being developed by Subcommittee F04.22 on Arthroplasty, part of ASTM International Committee F04 on Medical and Surgical Materials and Devices.

According to Gokce Yildirim, research engineer, Stryker MAKO, and a member of F04, the test in ASTM WK45235 is for materials used in transplants for a middle-aged population (40 and up) who have arthritis forming on the medial side of their knees, but who have healthy cruciate ligaments. “Solving the arthritis pain issue is known to restore normal knee function and give patients more mobility for their daily lives,” says Yildirim.

Yildirim notes that the testing described in ASTM WK45235 mirrors fatigue testing that covers total knee replacement tibial trays. Once the standard has been approved, it will be used by medical device companies as well as testing laboratories. The purpose of the test will be to indicate that the tibial metal component will not fail over its expected lifetime.

All interested parties are invited to join in the ongoing development of ASTM WK45235. ASTM International welcomes participation in the development of its standards. For more information on becoming an ASTM member, visit

For more news in this sector, visit or follow us on Twitter @ASTMMedical.

ASTM Committee F04 Next Meeting: May 6-9, 2014, May Committee Week, Toronto, Ontario, Canada
Technical Contact: Gokce Yildirim, Stryker MAKO, Jersey City, N.J., Phone: 973-946-6994; 
ASTM Staff Contact: Pat Picariello, Phone: 610-832-9720; 
ASTM PR Contact: Barbara Schindler, Phone: 610-832-9603;

Release #9630

March 27, 2014

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