Affiliations: Department of Research and Development – Metals Group, Accellent, Collegeville, PA, USA
Note: [] Address for correspondence: Hao Chen, Department of Research and Development – Metals Group, Accellent Inc., 200 West 7th Avenue, Collegeville, PA 19426, USA. Tel.: +1 610 409 2226; Fax: +1 610 409 2237; E-mail: [email protected].
Abstract: We present a comparative analysis between biocompatibility test results of wrought and Metal Injection Molded (MIM) ASTM F562-02 UNS R30035 (MP35N) and F1537 UNS R31538 (CCM) alloy samples that have undergone the same generic orthopedic implant's mechanical, chemical surface pre-treatment, and a designed pre-testing sample preparation method. Because the biocompatibility properties resulting from this new MIM cobalt alloy process are not well understood, we conducted tests to evaluate cytotoxicity (in vitro), hemolysis (in vitro), toxicity effects (in vivo), tissue irritation level (in vivo), and pyrogenicity count (in vitro) on such samples. We show that our developed MIM MP35N and CCM materials and treatment processes are biocompatible, and that both the MIM and wrought samples, although somewhat different in microstructure and surface, do not show significant differences in biocompatibility.
