The Ideal Biomaterial

Since its inception, SINTX Technologies has been focused on medical-grade silicon nitride. SINTX’s MC2™ silicon nitride is biocompatible, bioactive, antipathogenic (in its AP2 powder state), , and has shown superb bone affinity3.

It can be polished to a smooth and wear-resistant surface for articulating applications, such as bearings for hip and knee replacements4,5,6.Because of its inherent resistance to bacterial adhesion, silicon nitride is also suitable as a dental implant material.

Bacterial infection of any biomaterial implants is always a concern. Silicon nitride is inherently resistant to bacterial colonization and biofilm formation, making it antibacterial.

icon spine

Spinal Implants

With over 35,000 human spine implantations over 10 years and a very low percentage of reported adverse events, silicon nitride has an excellent safety record4. It is biocompatible, bioactive, and has shown bacterial resistance and superb bone affinity3.
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dental

Dental Implants

As a dental implant material, silicon nitride has been thoroughly tested to ISO 10993-01 standards and been shown to be highly biocompatible. Silicon nitride is metal free, like all ceramics, and free of corrosion, galvanism, and electronic disturbances.
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Craniomaxillofacial

Craniomaxillofacial

When used in implants for CMF applications, silicon nitride has the potential to accelerate bone healing, eliminate metal toxicity, and enhance radiographic imaging. Because it’s antipathogenic, silicon nitride can also decrease infection rates and ease the health care burden associated with failed implants.
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Key Benefits in Biomedical Applications

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Enhanced Osteopromotion

The surface chemistry and nanostructure topography of silicon nitride provide an optimal environment for the stimulation of osteoprogenitor cells to differentiate into osteoblasts1.

Bacteriostatic Properties

Silicon nitride demonstrates significantly lower biofilm formation at 4, 24, 48 and 72 hours as compared to PEEK and titanium.

Increased Protein Adsorption

Silicon nitride demonstrates significantly greater protein adsorption in comparison to PEEK and titanium. Proteins such as fibronectin, laminin, and vitronectin are key to the osteogenic process2.

Compatible with All Imaging Modalities

Silicon nitride implants are radiolucent with clearly visible boundaries and produce no artifacts or scattering under CT and no distortion under MRI. This enables an exact view of the implant for precise intraoperative placement and postoperative fusion assessment7.

Greater New Bone Formation

Silicon nitride implants demonstrate greater new bone formation at 3, 7, 14, and 90 days, and regenerated bone associated with silicon nitride implants is 2-3 times greater than PEEK and titanium implants three months after surgery8.

References

1. Ref: Pezzotti, G. et.al. In Situ Spectroscopic Screening of Osteosarcoma Living Cells on Stoichiometry-Modulated Silicon Nitride Bioceramic Surfaces. ACS Biomater. Sci. Eng., 2 [7] 1121–1134 (2016).

2. Ref: Gorth DJ, Puckett S, Ercan B, Webster TJ, Rahaman M, Bal BS. Decreased bacteria activity on Si3N4 surfaces compared with PEEK or titanium. Int J Nanomedicine. 2012;7:4829-4840.

3. T.J. Webster, A.A. Patel, M.N. Rahaman, and B.S. Bal, “Anti-Infective and Osteointegration Properties of Silicon Nitride, Poly (Ether Ether Ketone), and Titanium Implants,” Acta Biomater., 8 [12] 4447–4454 (2012).

4. Y.S. Zhou, M. Ohashi, N. Tomita, K. Ikeuchi, and K. Takashima, “Study on the Possibility of Silicon Nitride—Silicon Nitride as a Material for Hip Prostheses,” Mater. Sci. Eng. C, 5 125–129 (1997).

4. Personal Communication from Jason Parberry, Director of Regulatory Affairs and Quality Assurance, Amedica Corporation, Salt Lake City, UT 84119, (2018).

5. M. Mazzocchi, D. Gardini, P.L. Traverso, M.G. Faga, and A. Bellosi, “On the Possibility of Silicon Nitride as a Ceramic for Structural Orthopaedic Implants. Part II: Chemical Stability and Wear Resistance in Body Environment,” J. Mater. Sci. Mater. Med., 19 2889–2901 (2008).

6. M. Mazzocchi and A. Bellosi, “On the Possibility of Silicon Nitride as a Ceramic for Structural Orthopaedic Implants. Part I: Processing, Microstructure, Mechanical Properties, Cytotoxicity,” J. Mater. Sci. Mater. Med., 19 2881–2887 (2008).

7. Ref: M. Anderson, J. Bernero, and D. Brodke, Medical Imaging Characteristics of Silicon Nitride Ceramic A New Material for Spinal Arthroplasty Implants; p. 547 8th Annu. Spine Arthroplast. Soc. Glob. Symp. Motion Preserv. Technol. Miami, FL, 2008.

8. Ref: Gorth DJ, Puckett S, Ercan B, Webster TJ, Rahaman M, Bal BS. Decreased bacteria activity on Si3N4 surfaces compared with PEEK or titanium. Int J Nanomedicine. 2012;7:4829-4840.

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