IBI designed SmartBone following a bottom-up approach: starting from its microstructure that, mimicking
natural bone, allows to obtain a device that matches the macroscopic characteristics of a healthy human bone.
Biocompatibility is a granted feature: all components used in the production of SmartBone are taken only from
the market of materials already approved for human use (by both EMEA and US-FDA)!
Furthermore, all the steps of the production process of SmartBone are performed under strict GMP compliance.
All investigations performed under all ISO-10993 standards gave EXCELLENT results, confirming a VERY HIGH
BIOCOMPATIBILITY of SmartBone.
All in vivo investigations and clinical trials gave excellent results, fully confirming the high biocompatibility
of SmartBone and its impressive performances.
B. ADEQUATE-SIZED OPEN POROSITY & MICROSTRUCTURE
The first claim of IBI SmartBone is its human-like microstructure, which we evaluated via electron microscopy
and microCT scanning.
• Evaluation Technique and Instruments
We chose Environmental Scanning Electron Microscopy (E/SEM) as main technique to evaluate SmartBone
microstructure and morphology. A top level instrument was chosen to perform these investigations: a Evo 50
EP by Zeiss (Jena, Germany). Furthermore, thanks to the high investigative performances at extended pressure
of the available instrument, no metallization nor any other preparatory treatment were needed on the samples
prior to investigations.
Thanks to a cooperation with Phoenix|x-ray (a GE company), we performed microCT scans on our SmartBone
(applying a VTomEx-s equipment) to investigate geometrical and volumetric properties.
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