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Curiteva’s first Inspire Porous PEEK 3D printed cervical spine implant obtained FDA approval

On February 14, 2023, Curiteva, a medical technology company specializing in orthopedic implants, announced the launch of the first 3D printed PEEK cervical fusion cage implant licensed by FDA 510 (k). The implant design uses a porous design for additive manufacturing and a patented HAFUSE (hydroxyapatite) surface nano texture.

Inspire Porous PEEK 3D printing cervical fusion cage

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The 3D printing technology used for this implant is Curiteva's patented Fused Filament Fabrication (FFF) 3D printing technology, which uses a material melt extrusion additive manufacturing process.

It is reported that this additive manufacturing 3D printing technology creates a fully interconnected and integrated porous structure that runs through the entire implant. Its advantage is that it can promote bone integration, improve X-ray examination results, and achieve a closely matched elastic modulus with human cancellous bone.

Design principles and product characteristics

Design principles

The advantage of PEEK is that its elastic modulus matches cancellous bone and radiographic permeability, allowing doctors to accurately assess the fusion status over time;

The patented fused wire 3D printer has completed the design of the entire implant, with a fully interconnected porous structure that mimics natural bones;

The patented HAFUSE (hydroxyapatite) surface nano texture is designed to promote faster enhanced bone integration.

Inspire's lattice porous architecture provides flexibility to reduce overall stiffness and prevent stress shielding by matching the elastic modulus of cancellous bone.

Implant structure

Fused wire 3D printing technology (FFF) creates a new porous scaffold structure that mimics natural human bones;

100% fully interconnected porosity;

The pore size distribution is between 100 and 600 microns, promoting bone conduction;

Diamond-shaped pores (Triple Periodic Minimum Surface, TPMS) have been documented as having excellent biomechanical and biological properties;

Micron level surface roughness presents a hydrophilic surface, promoting bone adhesion and enhancing bone integration;

HAFUSE surface nano textures simulate physiological bones.

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