SINTX Technologies has completed construction of a 3D-printing facility as it targets 2027 for initial availability of patient-specific orthopedic implants.
The company has received its EXT-220 MED medical-grade 3D-printing systems and expects to obtain its proprietary silicon nitride-polyetheretherketone (SiN/PEEK) filament from Evonik before the end of 2026, it said Nov. 11.
SINTX is pursuing FDA 510(k) clearance for patient-specific extremity implants and evaluating limited custom-device opportunities in the first quarter of 2027. It also plans to expand into craniomaxillofacial and spinal applications later that year, pending regulatory review. Broader commercial distribution will require regulatory clearance and manufacturing validation.
The company’s SiN/PEEK composite combines a medical-grade polymer with silicon nitride, a ceramic studied for its antibacterial and bone-growth properties. In laboratory testing of 3D-printed spinal cage designs, researchers reported a 93.9% reduction in bacterial adhesion compared with conventional PEEK. The findings have not yet been validated in clinical use.
SINTX also appointed James Smith, PhD, as director of 3D additive manufacturing. He will oversee process development, material optimization, manufacturing validation and the advancement of the company’s custom and patient-specific implant portfolio.
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