ZIACOM® implants are manufactured with Zitium® high-grade titanium grade 4, which gives it a substantial improvement in its elastic limit and mechanical properties, maintaining compliance with the requirements of ASTM F67 and ISO 5832-2 and Certified according to the requirements of the Medical Directive 93/42 / EEC and its amendment 2007/47 / EC by the notified body 0051.
Phases of the manufacturing process of ZIACOM® implants
ZIACOM® has the license of manufacturer of sanitary products and the authorization of commercialization by AEMPS (Spanish Agency of the Medicine and Sanitary Product). Our Quality Management System is certified according to the requirements of UNE-EN-ISO 9001: 2008 and UNE-EN-ISO 13485: 2012, in addition to the requirements of GMP 21 CFR 820
The Osseonova® surface is textured by subtraction. The process consists of three distinct phases, firstly a sandblasted with White Corundum, in a second phase is made a double etching acid acid in which elements such as hydrofluoric acid, phosphoric acid and acid sulfuric. This process allows us to achieve a macro and micro porosity with average values of 2 microns between peaks, which is a key feature to achieve optimal osseointegration. With these characteristics the Osseonova® surface gives ZIACOM® implants great reliability and predictability in the treatments.
The third phase of the treatment is the cleaning and decontamination of the Osseonova® surface by a cold argon plasma process. It performs surface cleaning with electrically charged argon ions. Argon plasma is non-reactive and, despite being chemically inert, the heavy ions created in argon plasma generation are capable of bombarding surfaces and dislodging impurities from the material, thereby achieving meticulous cleaning of the Surfaces at the molecular level. Argon plasma does not react with the surface but leaves a layer of highly reactive radicals which due to their high conductivity increase the adhesion capacity of the surfaces. Argon plasma increases the adhesion of surfaces. The process described is generally known as a micro-sandblasting.
Plasma cleaning technology offers better results in eliminating contaminants (even at nanometer scale) than any other conventional cleaning technique, with the added advantage that by not using chemical baths, there is no risk, cross-contamination or residue to eliminate later.
Sterilization by Beta Ray Radiation
Finally, ZIACOM® implants are sterilized by irradiation with Beta-rays at 25 kGy.