Applied Technology

Two Titanium alloy Devices Completed Clinical Trials

The new Ti2448 titanium alloy for medical use developed by Yang Rui, Hao Yulin and their colleagues from the Engineering Alloys Division, Shenyang National Laboratory for Materials Science, Institute of Metal Research, CAS was granted a US patent (US 7,722,805) on May 28. In addition, the two types of implantation devices made of Ti2448 alloy, which are bone plate for orthopedic use and spinal internal fixation system, have completed clinical trials in several hospitals and entered into the stage of large-scale application. Ti2448 alloy and its method of processing and preparation was granted a national invention patent (CN 2004100928 58.1) in 2007. The Institute of Metal Research, CAS has been carrying out sustained cooperative research with some medical universities and other medical units in terms of Ti2448 and its application and obtained large amounts of specific and reliable data in materials, surface bioactive treatment, in vitro cell, in vivo animal test and other areas, succeeded in developing elastic bone plate for wound, elastic intramedullary nail, elastic spinal internal fixation system and other products, and completed biomechanical characterization, fatigue life test and animal experiment for these products. These cooperative research results provide important scientific foundations for promoting the medical use of Ti2448. Through cooperation with the Wego Orthopedic Materials Co. Ltd., the Institute of Metal Research has been engaged in the development of implantation devices and application for product registration certificate since 2005. Now, the clinical trials of these two products have been completed. The Wego Orthopedic Materials Co. Ltd. has already applied to the State Food and Drug Supervision Administration for registration certificate of these products.