SureMAX by Additive Implants Inc. innovative cervical implant

SureMAX

Cervical Implant for Additive Implants Inc

SureMAX is the first Titanium spinal implant that has a stiffness that matches the individual's bone stiffness as not to damage it once implanted. Bone loves to grow into Titanium but legacy Titanium cages have been limited because they are too stiff and damage the bone once implanted. SureMAX has solved this problem through using 3D print technology with geometries that are not machinable. It also has a porous roughen surface to encourage bone to grow into it. The 'diving' boards on SureMAX adjust to the patient's bone stiffness to assure the best fit and performance.

Additive Implants Inc. 2020 Startup Bronze Press Kit № 88502

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SureMAX by Additive Implants Inc

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Cervical Implant by Additive Implants Inc

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Additive Implants Inc Corporate Logo

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SureMAX Cervical Implant Media Articles

Our SureMAX articles are prepped and available in these languages: German, Portuguese, Japanese, Russian, English, Chinese (Mandarin), Hindi, French, Spanish, Turkish, Arabic (Standard), Indonesian, Korean and Italian, ready for your use.

Unique Properties

SureMAX is the first Titanium spinal implant that has a stiffness that matches the individual's bone stiffness as not to damage it. Bone loves to grow into Titanium but Titanium cages have been limited because they are too stiff and damage the bone. SureMAX has solved this problem through using 3D print technology with geometries that are not machinable. It also has a porous roughen surface to encourage bone to grow into it.

Production Technology

3D print technology has been used with Titanium powder (Ti6Al4) using porous surface technology to achieve designs that will encourage bone to grow into the spinal implant

Design Challenge

To get result required- a high performance implants which is cost competitive, the team had to design a part that could both hand the stresses and forces required by the US government FDA while solving the patient challenges. The part had to be designed so minimal post processing would be required after 3D printing. Additionally, the rough porous surface which helps the healing process required advance software and new methodologies to manufacture. The diving boards had to share the spinal loads equally in order not to displace the implant in the spine. Side windows had to be designed that permits the loads to be distributed and have large have enough surface to see the bone healing. The hardest part of the design activity was to figure out how 8 independent platforms on both sides of the implant could function as a single unit and share the loads appropriately. The surface had to be porous and roughened Ti that could handle the appropriate loads. The teeth had to be the correct size and angle in order to assure stability, but not too big or small to them a ineffective.

Project Duration

The design started in 2015 and ended in October 2018 and FDA approval was received in February 2019 (3 year design and 4 month approval). The work was done in Phoenix Arizona USA.

Operation Flow

The implant is used in an Anterior Cervical Discectomy Fusion (ACDF) surgery where the front of the neck is opened, the damaged cartilage removed and an implant is inserted in order to fuse the vertebra. The implant comes in a sterile plastic package. The surgeon once the damage is observed and removed assesses the size required. The appropriate implant size, angle and foot print is selected and inserted into the spine. A plate is then used (not part of SureMAX) to attach the upper and lower vertebra. The bone then grows into the implant (called inter body fusion device IBFD) and the patient heals.

Research

Titanium (Ti) has always been the material of choice for implants. But Ti is hard to machine and is very stiff. In the interface between Ti and bone, bone can be damaged and the implant subside ( or settle ) in the body. Plastic and Allograft bone material implants are used to address Ti's limitations. Additional, Ti is not X-ray translucent, so physicians can not see how the bone heals through and around the implant. Plastic implants also have the limitation that they remain inert in the body- they are never adsorbed. Bone however grows very well into Ti. The challenge was to create a Ti spinal cervical implant (cervical is for the neck) that had the same stiffness as bone as not to damage it, would not subside (it would stay on top of the bone and not settle), would remain in the position inserted (with the neck movement would not slip), X-ray could go through it (healing could be observed), would pass the stress test required by the FDA and would be cost effective.

Inspiration

The inspiration was the lack of a solution that took advantage of new geometries that can be created with Titanium which is the best material for bone to grow into by a spine surgeon who performs over 300 cervical surgeries a year. He wanted an implant made from Titanium that matched bone's hardness, not to damage the vertebra, was visible in X-rays, so healing could be seen through, and would not subside in the spine.

Project Overview

SureMAX Cervical Implant has been a Bronze winner in the Medical Devices and Medical Equipment Design award category in the year 2019 organized by the prestigious A' Design Award & Competition. The Bronze A' Design Award is given to outstanding designs that showcase a high degree of creativity and practicality. It recognizes the dedication and skill of designers who produce work that stands out for its thoughtful development and innovative use of materials and technology. These designs are acknowledged for their professional execution and potential to influence industry standards positively. Winning this award highlights the designer's ability to blend form and function effectively, offering solutions that enhance people's lives and wellbeing.

Image Credits

For design images and photos please credit Additive Implants Inc..

Bronze Recognition

Additive Implants Inc. was recognized with the coveted Bronze A' Design Award in 2020, a testament to excellence of their work SureMAX Cervical Implant.

Additive Implants Inc. Newsroom

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