We Answer Our Top 10 FAQ's!

Welcome to the latest edition of our newsletter. Last edition, we gave you a sneak peek into our frequently asked questions. In this edition, we are addressing more of your most pressing questions about our nanoVIS Ti? Surface Technology.

As pioneers in nanotech for medical implants, we understand the importance of clarity and precision in our communications. Whether you're a seasoned medical professional or a new partner, this guide will enhance your understanding and confidence in the innovative solutions that we offer. Let's dive into the details and explore how our technology is setting new standards in the industry.

How durable is Nanovis nanotechnology surface?

The surface is exceptionally durable. The titanium dioxide is not soluble in body fluids, not prone to corrosion, nor susceptible to cell or enzymatic degradation. These factors result in a surface that is present for the lifetime of the implant.

For example, if a patient had an accident post-surgery and the implant that includes Nanovis nanotechnology surface loosened due to trauma, the still-present nanotechnology surface could speed the healing process to re-osseointegrate the implant into host tissue.

Does Nanovis nanotechnology surface modification have an impact on mechanical testing?

Because each type of implant and potential application is unique, it is difficult to give a one-size-fits-all answer. However, given the size of most orthopedic implants, it is safe to say the application of the surface will not have a meaningful effect on strength. With the process of removing such a small amount of material (.00002”), the removed material should be an insignificant amount of the total construct.

How does Nanovis nanotechnology surface improve a surface that is micron roughened or macroporous?

Micron-roughened and porous surfaces are good for improving bone cell response and offering cells a 3D space to grow into, which mimics their natural environment. However, cells are not the smallest unit in the body; proteins are. Nano surfaces are best at attracting proteins and mimicking the natural nanostructures found in bone. The optimal environment for cells and tissue to grow is one that mimics the natural environment at the macro, micro, and nano scales.

Is Nanovis nanotechnology surface biocompatible, and have you done testing? Yes, Nanovis nanotechnology surface is biocompatible. For the first 510(k) submission with this technology back in 2019, a master file was created, including biocompatibility testing, with ISO 10993 testing being the foundation. Since that time, the master file has been referenced on five 510(k) cleared devices in two different product categories (fusion cages and pedicle screws).

Does Nanovis nanotechnology surface change the fit, form and function of my existing implants and instrumentation?

The nanotechnology surface process will not change the fit, form, or function of existing implants or instrumentation. The process removes approximately 500 nanometers (.00002”) from the surface, less than any manufacturing tolerances. The process will not remove laser labels that are applied before nanotechnology surface processing.

How long does the biological phenomenon of Nanovis nanotechnology surface last?

The nanoVIS Ti? Surface Technology will last the lifetime of the implant. The nanotechnology surface is composed of titanium dioxide and thus is not soluble in body fluids, is not prone to corrosion, or is susceptible to cell or enzymatic degradation.

Why does Nanovis nanotechnology surface need to be sterile packaged, and what processes are compatible?

Nanosurfaces have substantial amounts of additional surface area and can be “sticky” when it comes to anything in the environment that could reduce the surface's effectiveness. Sterile packaging is required to preserve the biological properties of the nanosurface. Nanovis nanotechnology surface is compatible with eBeam, gamma, and peroxide vapor sterilization techniques.

What validations need to happen to apply Nanovis nanotechnology surface to other company's implants?

To ensure the quality and consistency of our nanotechnology surface, Nanovis traditionally performs process validations for each new product family that we introduce. Validations encompass worst-case (high/low) product surface areas and can typically cover a wide range of sizes within a product offering. In addition, Nanovis may be able to leverage existing validations in cases where product configurations and part fixturing fall within currently validated systems.

When does nano processing happen within the supply chain?

The application of Nanovis nanotechnology surface is typically the final step in the supply chain process prior to sterile packaging. This ensures that parts are adequately cleaned and prepped for the nano application and that the surface is preserved and protected upon completion. If product types/configurations require the assembly of additional components, subsequent assembly processes are performed in a clean room environment to preserve the integrity of the nano-surfaced components.

Is Nanovis nanotechnology surface a coating?

Nope! The titanium dioxide that makes the nanotubes comes from the metal on the surface of the implant. The converted material is well-integrated into the metal surface, ensuring that delamination does not occur. A similar concept is used when a device is color-anodized. However, this protected and specialized anodization process allows us to specifically program the nanotube size and dimension that drives a biological phenomenon (nanotechnology designation). Therefore, Nanovis nanotechnology surface is not applied to the surface like a coating but is a part of the implant’s surface.

Have more questions? Find us at OMTEC or reach out directly!