The Ideal Biomaterial

Since its inception, SINTX Technologies has been focused on medical-grade silicon nitride. SINTX’s FleX-SN MC², FleX-SN CSC, FleX-SN PEEK, and FleX-SN AP products are biocompatible, bioactive, antipathogenic, and have shown superb bone affinity⁴.

FleX-SN products can be polished to a smooth and wear-resistant surface for articulating applications, such as bearings for hip and knee replacements⁸^,⁹^,¹⁰. Because of their inherent resistance to bacterial adhesion¹¹, they are also suitable as dental implant material.

Bacterial infection of any biomaterial implants is always a concern. FleX-SN is inherently resistant to bacterial colonization and biofilm formation, making it antibacterial ¹¹^,¹².

Spinal Implants

With over 40,000 human spine implantations over the last 10 years and a very low percentage of reported adverse events, FleX SN has an excellent safety record ⁸. It is biocompatible, bioactive, and has shown bacterial resistance and superb bone affinity⁴.

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Dental Implants

As a dental implant material, FleX-SN has been thoroughly tested to ISO 10993-01 standards and is highly biocompatible ⁵^,¹³^,¹⁴. Silicon nitride is metal-free, like all ceramics, and free of corrosion, galvanism, and electronic disturbances.

Craniomaxillofacial

When used in implants for CMF applications, FleX-SN has the potential to accelerate bone healing, eliminate metal toxicity, and enhance radiographic imaging. Because it’s antipathogenic ¹⁴^,¹⁵^,¹⁶^,¹⁷, silicon nitride can also decrease infection rates and ease the health care burden associated with failed implants.

Wound Care

Proper wound care is essential to the prevention of surgical site infections caused by MRSA (Methicillin-resistant Staphylococcus Aureus) and VRE (Vancomycin-resistant Enterococci). SINTX is working with partners to provide continuous antimicrobial protection that prevents the proliferation of bacteria on and in the dressing. FleX-SN AP makes these wound dressings effective against a broad range of gram-positive and gram-negative bacteria¹⁹.

Foot Osteotomy & Fusion

Fusion foot osteotomy procedures are performed to address fractures, bunions, hammertoe, or flat foot conditions. In these procedures, bone is cut and reshaped to alleviate pain. Implant materials are used to facilitate bone fusion. Silicon nitride has the flexibility of a dense, porous, or combined architecture that can mimic the cortical-cancellous structure of bone¹⁸^,²⁰.This characteristic combined with numerous other benefits, such as antibacterial resistance ²¹, make silicon nitride a strong consideration as an implant material in this application.

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.

Key Benefits in Biomedical Applications

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.