Nivalon Medical claims to have manufactured the first fully patient-specific, motion-preserving spinal implant without metal. It is based on CT-based AI-supported design processes and ceramic 3D printing (ZTA end plates) combined with an elastomeric core designed to replicate natural movement. The first human applications are planned for 2026.
Structurally, the system combines a load-bearing ceramic architecture made of zirconia-toughened alumina (ZTA) with an elastomeric core. The goal is for the ceramic endplates to serve as bone-like contact surfaces, while the core enables motion instead of relying on it only through
“I realized the problem wasn’t the surgeons—it was the implants,” said Hodrinsky. “We were trying to treat a living biological structure with industrial metal hardware that was never designed to behave like bone or properly follow natural spinal motion. We knew we could engineer something fundamentally better.”
For pre-validation, the company cites independent testing at the University of South Florida and the University of Connecticut Institute of Materials Science. In Florida, motion tests were run on a six-degrees-of-freedom DISC simulator under physiological load; the reported stiffness curves and motion profiles are said to be close to native behavior. In Connecticut, the current design reached 14.6 kN in compression tests, complemented by shear testing for interface integrity. In addition, samples were stored in simulated body fluid and analyzed via SEM-EDX to assess mineral deposition and surface interaction. Cadaver studies supported surgical planning, including sagittal balance and facet joint alignment.
“This is more than a technical achievement—it’s personal,” said Hodrinsky and Janse. “The endplates for my own spine are now complete. This is the difference between living with chronic complications and restoring a normal, active life.”
According to Nivalon, manufacturing was carried out in cooperation with the Youngstown Business Incubator on an XJet system using NanoParticle Jetting. The first procedures in humans are planned for 2026, including for the CEO. Whether the concept holds up clinically will be determined by long-term wear, wear debris, osseointegration, and the data requirements of the FDA PMA process; in parallel, Nivalon is seeking a NIH SBIR Phase II award.
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