Additive Manufacturing When the Spine Comes Out of the 3D Printer

Related Vendors

FAULHABER Drive Systems

Taiwan Machine Tool & Accessory Builders' Association (TMBA)

SIMTOS (Seoul International Machine Tool Show)

Nivalon Medical has produced a fully patient-specific, motion-preserving, metal-free spinal implant using ceramic 3D printing. The implant thus sets new standards for additive manufacturing in the medical sector.

Conventional spinal implants are manufactured in standard sizes and therefore cannot be optimally adapted to the individual anatomy of each patient. This leads to suboptimal load distribution, implant displacement and long-term complications. Metal incompatibilities and adverse biological reactions pose additional risks.What began as a personal mission of Todd Hodrinsky and Marcel Janse, co-founders of Nivalon Medical Technologies, has evolved into a new approach to spinal care, replacing metal with bone-like ceramics, standard sizes with a patient-specific design and rigid fixation with natural biomechanics. "We realized that the problem was not with the surgeons, but with the implants," says Hodrinsky. "We had tried to treat a living biological structure with industrial metal elements that do not behave like bone and are unable to follow the natural movements of the spine. It was clear that we had to develop something fundamentally new and better."

Gallery

Together with the Youngstown Business Incubator (YBI), Nivalon has developed the groundbreaking EvoFlex medical device. It combines a proprietary architecture of zirconia-reinforced alumina ceramic (ZTA), which has bone-like properties, with a flexible elastomeric core to mimic the natural movement of the spine. The result is a new category of spinal implants that take into account both human anatomy and natural biomechanics. The first application in patients is planned for 2026, including Todd Hodrinsky, co-founder and CEO of Nivalon.
Unlike conventional implants, which are manufactured in standard sizes from metal alloys, Nivalon's EvoFlex is digitally designed based on each patient's CT data and precisely customized to their individual anatomy using 3D printing. The result is a bone-like ceramic structure that eliminates metal-related complications such as corrosion, ion release, stiffness differences and imaging interference without compromising the natural movements of the spine.

Better Material Properties And Higher Biocompatibility After Sintering

Using XJet's NanoParticle Jetting ceramic 3D printing technology, Nivalon was able to design and manufacture a load-bearing spinal implant architecture made of pure, high-density ceramic. "For us, XJet is not only the best platform for manufacturing implants from high-performance ceramics—it's also a key enabler for our personalized approach," says Hodrinsky. "Unlike many other additive manufacturing processes that rely on polymer-based binders, XJet uses a water-based system, which we believe leads to better material properties and higher biocompatibility after sintering. The NPJ platform also allows for exceptionally high resolution and surface detail, which is critical for replicating the complex anatomical contours of vertebral endplates, including complex lattice structures for bone integration and polymer bonding to the material. This accuracy contributes significantly to a better fit and performance of the implants."

The implants were subjected to several tests conducted at the University of South Florida (USF) and the University of Connecticut Institute of Materials Science (UConn IMS). At USF, EvoFlex implants were tested on the Dynamic Investigation of Spine Characteristics (DISC) simulator with six degrees of freedom under physiologic load on the spine. These tests resulted in stiffness curves and motion profiles that closely resemble the natural behavior of the human spine. The compression and shear tests conducted at UConn IMS showed significant improvements in structural performance. The new design allows compressive loads of 14.6 kN, equivalent to a force of approximately 3,300 pounds. The UConn IMS also conducted simulated body fluid (SBF) testing and SEM-EDX analysis, which confirmed that the ZTA ceramic not only supports uniform mineral deposition and biologically relevant ion interaction, but also exhibits bone-like surface behavior and long-term osseointegration potential. In contrast to metals, the ceramic showed a consistent, controlled and predictable biological response.

The endplates for my own spine are now ready. This is the difference between a life with chronic pain and a return to normality and physical activity..

Todd Hodrinsky

The prototype demonstrates the successful transition from research to scalable clinical manufacturing. With two U.S. patents already issued and six patents pending, Nivalon is preparing for NIH Phase II SBIR funding, clinical trials for FDA PMA approval and first-in-patient use planned for 2026. "This is more than a technical achievement—it's something very personal," said Hodrinsky and Janse. "The endplates for my own spine are now ready. It's the difference between living with chronic pain and returning to normality and physical activity."

Additive manufacturing

Basic knowledge 3D printing