title: Biocompatibility of metal injection molded versus wrought ASTM F562 (MP35N) and ASTM F1537 (CCM) cobalt alloys.
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.
authors.affiliation: Department of Research and Development-Metals Group, Accellent Inc., Collegeville, PA 19426, USA. haoc@umich.edu
authors.forename: Hao
authors.initials: H
authors.lastname: Chen
authors.forename: Alan
authors.initials: A
authors.lastname: Sago
authors.forename: Shari
authors.initials: S
authors.lastname: West
authors.forename: Jeff
authors.initials: J
authors.lastname: Farina
authors.forename: John
authors.initials: J
authors.lastname: Eckert
authors.forename: Mark
authors.initials: M
authors.lastname: Broadley
mesh_terms: D000497:Alloys / Q000737:chemistry / Q000378:metabolism* / Q000633:toxicity; D000818:Animals; D001672:Biocompatible Materials / Q000737:chemistry / Q000378:metabolism* / Q000633:toxicity; D002460:Cell Line; D002470:Cell Survival; D003035:Cobalt / Q000737:chemistry / Q000378:metabolism* / Q000633:toxicity; D004912:Erythrocytes / Q000166:cytology; D005347:Fibroblasts / Q000166:cytology; D006461:Hemolysis; D008422:Materials Testing; D051379:Mice; D011817:Rabbits; D013499:Surface Properties; D018675:Toxicity Tests
chemical_list: D000497:Alloys; D001672:Biocompatible Materials; C035402:MP35N alloy; D003035:Cobalt