Technical Data Sheet

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FleX-SN MC2: What is it?

WHAT MAKES IT DIFFERENT?

SINTX’s FleX-SN MC2 is the only dense silicon nitride material with a history of experimental and clinical data (over 130 peer-reviewed publications) to support its use inside the body. It is also the only silicon nitride material used in FDA-cleared medical implants.

Beneficial Properties of Silicon Nitride (FleX-SN MC2):

  • Material phase stability44
  • Strength and fracture toughness42
  • Hydrophilicity45
  • Bacterial resistance46,11
  • Favorable imaging47
  • Wear resistance44,48
  • Osteoconductivity6,7,12
  • Osteoinductivity13,49

Spinal Implants

With over 40,000 human spine implantations over the past 10 years and a very low percentage of reported adverse events, FleX-SN MC2 has an excellent safety record8. It is biocompatible, bioactive, and has shown bacterial resistance and superb bone affinity4.

Dental Implants

As a dental implant material, FleX-SN MC2 has been thoroughly tested to ISO 10993-01 standards and been shown to be highly biocompatible5,13,14. Silicon nitride is metal free, like all ceramics, and free of corrosion, galvanism, and electronic disturbances.

Arthroplasty

When compared to other biomaterials, FleX-SN MC2 has been shown to remove oxygen from the tribo-layer22,23,24,25, potentially avoiding long-term degradation of polyethylene in hip and knee replacements and extending the life of these synthetic joints.
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