INSPIRE® 3d PRINTED TRABECULAR PEEKTM WITH HAFUSE® TECHNOLOGY
A Breakthrough in Additive Manufacturing for Medical Devices
Inspire Design Rationale
The benefit of Inspire 3D-Printed Trabecular PEEK® is a modulus of elasticity matching cancellous bone and radiolucency allowing physicians to accurately assess fusion progression over time.1,4
Engineered, Fully Interconnected Porous Structure throughout the implant, enabled by proprietary Fused Filament Fabrication 3D Printer, designed to mimic natural bone
Pore size distribution between 100 – 600 microns designed to promote Osteoconduction5,6,10
Proprietary HAFUSE (Hydroxyapatite) Sub-Micron Surface Texture is designed to encourage faster Osseointegration.2
Material Comparison
The flexibility of Inspire lattice architecture is crafted in compliance with Wolff’s Law to reduce the overall stiffness and prevent stress shielding by matching the modulus of elasticity of cancellous bone.3,4
TRUE POROSITY
100% Fully Interconnected Porosity
Structure Drives Biology
Proprietary Fused Filament Fabrication (FFF) – novel porous scaffolding structure designed to mimic natural human bone
Pore size distribution between 100 – 600 microns designed to promote Osteoconduction5,6,10
Diamond shape pores (Triply Periodic Minimal Surface, TPMS), documented in literature as possessing superior biomechanic and biologic properties7
HAFUSE sub-micron surface texture incorporates 300nm HA whiskers, designed to mimic physiologic bone2
Structure Designed to Mimic the Morphology of Cancellous Bone
Inspire Implant
Human Cancellous Bone
HAFUSE Promotes Osseointegration
Micron-scale surface roughness presents hydrophilic surfaces, which can lead to better bone apposition and enhanced Osseointegration, as observed in our animal study8
SUB-MICRON SURFACE TEXTURE
HA is bonded to 100% of the implant surface throughout the entire structure
Sub-micron surface texture is designed to help bone anchor directly to the implant surface, creating superior mechanical stability2,8
Pre-clinical studies have shown this surface morphology designed to mimic cancellous bone leads to improved Osseointegration as compared to solid PEEK implants2,8,9
12 week Micro CT Images (ovine)*
12 week Histology Images (ovine)*
A Breakthrough in Additive Manufacturing
The Inspire HAFUSE interbody platform is manufactured with a proprietary, patented 3D printer utilizing novel equipment, electronics, software, firmware, and slicing algorithms developed by the company. This advancement positions Curiteva to control product development of 3D printed PEEK devices from inception to commercialization.
A True Platform Technology
The Inspire Trabecular PEEK with HAFUSE platform represents a revolution in biomaterials by delivering an interconnected porous, engineered structure designed for Osseointegration, radiographic assessment, and improved patient outcomes.
- Spine Applications
- Orthopedic Applications
- Sports Medicine Applications
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Curiteva designs, develops, manufactures, and commercializes surgical instruments and implants focusing on delivering true innovation to the market in addition to core spine products surgeons use every day.
Additional Resources
References
1V. Goel, Biomechanical rationale for using polyetheretherketone (PEEK) spacers for lumbar interbody fusion-A finite element study, Spine (2006).
2Promimic – Research Monograph, Summary of Preclinical & Clinical Studies -14 published studies (2021).
3Wolff J. “The Law of Bone Remodeling”. Berlin Heidelberg New York: Springer, 1986 (translation of the German 1892 edition).
4Youngs Modulus comparison of various materials GUM00001 rev A/ VAL 2017-007.
5Vijayavenkataraman, S., Kuan, L.Y., Lu, W.F., 2020. 3D-printed ceramic triply periodic minimal surface structures for design of functionally graded bone implants. Mater. Des. 108602.
6Liu, F., Mao, Z., Zhang, P., Zhang, D.Z., Jiang, J., Ma, Z., 2018b. Functionally graded porous scaffolds in multiple patterns: new design method, physical and mechanical properties. Mater. Des. 160, 849–860.
7Spece, H., Yu, T., Law, A.W., Marcolongo, M., & Kurtz, S.M. (2020). 3D printed porous PEEK created via fused filament fabrication for osteoconductive orthopaedic surfaces. Journal of the Mechanical Behavior of Biomedical Materials.
8Data is derived from ovine studies. Please note in vitro and in vivo testing may not be representative of clinical experience.
9Jimbo, R., Coelho, P.G., Bryington, M., Baldassarri, M., Tovar, N., Currie, F., Hayashi, M., Janal, M.N., Andersson, M., & On, D. (2012). Nano Hydroxyapatite-Coated Implants Improve Bone Nanomechanical Properties. Journal of Dental Research, 91(12), 1172-1177.
10Feng, B., Jinkang, Z., Zhen, W., Jianxi, L., Jiang, C., Jian, L., Guolin, M., Xin, D., 2011. The effect of pore size on tissue ingrowth and neovascularization in porous bioceramics of controlled architecture in vivo. Biomed. Mater. 6 (1), 015007..
Additional references available by request.