Whoever tried it learned the hard way that obtaining FDA approval is not easy. For the uninitiated, this is the marketing authorization for any product issued by the influential Food and Drug Administration, the American Ministry for Health, regarded as the "strictest and most scrupulous" regulatory body in the world. Such a recognition is of crucial importance in terms of product quality, safety and effectiveness across all global markets. CustomizedBone Service, which is how the already known CustomBone Service is trademarked in the USA, obtained this approval at the end of a process which lasted about three-years.

This innovative technology has been developed by Finceramica. It deals with an implant or, to be more accurate, a custom-made regeneration support (hence its name CustomBone) which integrates seamlessly with the patient's skull. The bioceramic material employed is able to be colonized by vascularized areas, thus making for natural bone regeneration and complete implant reabsorption. Implant design starts on-line via a dedicated portal. Finceramica technicians analyse the patient's CT or MRI scan through an ad-hoc software, before designing and creating a 3D model of the implant which is then submitted to the surgeon for approval. The device is produced in a sterile environment through a number of processing stages, the first of which closely resemble those of a simple ceramic process. The biomaterial contains calcium just like the human bones, which makes it more compatible or "familiar" with the patient's body; this is what the cells expect to receive. The risks of rejection or infection are minimized. In most cases, it takes just one surgery for the patient to resume his normal life. This is the great benefit offered by such technology if compared with others: the need of just one surgery significantly reduces the risks of rejection and infection, while increasing the surgery success rate. These results are important in economic terms too, due to the reduction of medium- to long-term health care costs, so much so that several health systems, such as the French system, have adopted the technology as their reference resource for craniofacial surgeries.

The US health care market is the most lucrative in the world, with much higher prices than in Europe, 320 million users and an almost entirely private health care system. FDA approval means that CustomizedBone Service can now be marketed in that country. It also means that the partnership between Finceramica and Johnson&Johnson, the largest pharmaceutical-biomedical company in the world with its $70 billion annual turnover, has finally become truly global.