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Oxinium™ Metal Allergies And Biocompatibility

Between 3-8% of the population has been estimated to have metal allergies. Many of these people need a TJA but may not be candidates because of metal sensitivity.

Graph showing the nickel content of oxinium being nil compared with Titanium and Cobalt Chrome implants

The maximum nickel content for cobalt chrome can be as high as 1% compared to 0.1% for titanium alloy. The nickel content of Oxinium™ components cannot be detected.

Superior Biocompatibility

Like titanium, zirconium is one of the most biocompatible elements. The biocompatibility of the Oxinium™ material was confirmed by testing in accordance with ASTM and ISO standards, as follows:

  • TCytotoxicity (L929 MEM Fibroblast)
  • Sensitization (Kligman Maximization)
  • Genotoxicity (Ames Mutagenicity and Micronucleus Assay)
  • Implantation (90-Day Intramuscular and 6-Month Transcortical)
  • Intracutaneous Reactivity (Intracutaneous Injection)
  • Acute Toxicity (Systemic Injection and Pyrogenicity)
  • Haemocompatibility (Hemolysis)

The results indicated that the Oxinium™ material is at least as biocompatible as cobalt chrome and titanium alloy.