Technology
Materials
Get informed about the implant materials used at implantcast.
implavit® CoCrMo
The majority of implants are made of a cobalt chrome molybdenum (CoCrMo) casting alloy (according to ISO 5832-4). Casting molds are produced from reproducible wax models which are, via several steps, coated with a ceramic layer. After the wax has been melted out of these ceramic molds then the liquid CoCrMo alloy is carefully poured inside them. Once this has cooled the ceramic mold is removed from the casting blank and the components are checked for defects. Only then are they machined further and sent for finishing (i.e. ground, polished, coated, etc. – as applicable).
Composition
element | mass fraction in % |
| Chonium | 26.5 to 30 |
| Molybdenum | 4.5 to 7 |
| Nickel | max. 1.0 |
| Iron | max. 1.0 |
| Carbon | max. 0.35 |
| Manganese | max. 1.0 |
| Silicon | max. 1.0 |
| Cobalt | rest |
Composition
element | mass fraction in %alloy 1 (low carbon cotent) |
| Chromium | 26.0 bis 30.0 |
| Molybdenum | 5.0 bis 7.0 |
| Iron | max. 0.75 |
| Manganese | max. 1.0 |
| Silicon | max. 1.0 |
| Carbon | max. 0.14 |
| Nickel | max. 1.0 |
| Nitrogen | max. 0.25 |
| Cobalt | rest |
CoCrMo according to ISO 5832-12 is a wrought cobalt-chromium-molybdenum alloy for implants for surgery.
cpTi
cpTi is commercially pure titanium. The unalloyed titanium used in the manufacture of implants for surgery (e.g. AGILON®-components for the shoulder endoprosthetics) complies with ISO 5832-2. The chemical compositions of the titanium grades, which differ in their mechanical properties (e.g. tensile strength), are listed below.
Composition
element | mass fraction in % | ||||
Grade 1 | Grade 1 | Grade 2 | Grade 3 | Grade 4A | |
| Nitrogen | max. 0.012 | max. 0.03 | max. 0.03 | max. 0.05 | max. 0.05 |
| Carbon | max. 0.03 | max. 0.08 | max. 0.08 | max. 0.08 | max. 0.08 |
| Hydrogen | max. 0.0125a | max. 0.0125a | max. 0.0125a | max. 0.0125a | max. 0.0125a |
| Iron | max. 0.10 | max. 0.20 | max. 0.30 | max. 0.30 | max. 0.50 |
| Oxygen | max. 0.10 | max. 0.18 | max. 0.25 | max. 0.35 | max. 0.40 |
| Titanium | rest | rest | rest | rest | rest |
a Except for blocks for which the maximum hydrogen content shall be 0.0100% (mass fraction) and for flat products for which the maximum hydrogen content shall be 0.015% (mass fraction).
implatan®; TiAl6V4
The raw titanium (TiAl6V4) alloy material (according to ISO 5832-3) is machined – usually by milling and / or turning before being sent for finishing (i.e. ground, polished, coated, etc. – as applicable)
Composition
element | mass fraction in % |
| Aluminium | 5.5 to 6.75 |
| Vanadium | 3.5 to 4.5 |
| Iron | max. 0.3 |
| Oxygen | max. 0.2 |
| Carbon | max. 0.08 |
| Nitrogen | max. 0.05 |
| Hydrogen | max. 0.015 |
| Titanium | rest |
implatan®; TiAl6Nb7
Titanium Aluminium-6 Niobium-7 (TiAl6Nb7) according to ISO 5832-11 is a wrought titanium alloy used in the manufacture of implants for surgery.
Composition
element | mass fraction in % |
| Aluminium | 5.5 to 6.5 |
| Niobium | 6.5 to 7.5 |
| Tantalum | max. 0.50 |
| Iron | max. 0.25 |
| Oxygen | max. 0.20 |
| Carbon | max. 0.08 |
| Nitrogen | max. 0.05 |
| Hydrogen | max. 0.009 |
| Titanium | rest |
UHMWPE
Ultra high molecular weight polyethylene, or UHMWPE (according to ISO 5834-2), starts out as a powder which is compression molded to make rods. These are then heat-treated and cut into pucks or cubes for stress reduction before product-specific processing. The resultant implants are placed in gas-permeable packaging and sterilised using ethylene oxide (EtO).
implacross®
This is a version of UHMWPE (according to ISO 5834-1) which has been crosslinked to decrease wear rates. The rod material (formed from compression molding GUR 1020 powder) is gamma-irradiated with 75kGy in the atmosphere at room temperature. The rod is then heated to 150°C ± 2°C for 10 hours before being allowed to return to room temperature.
implacross® E
This is a vitamin E stabilised version of the crosslinked implacross® UHMWPE material (hence implacross® E also complies with ISO 5834-1). In this instance however 1000 ppm of vitamin E is thoroughly mixed with the GUR 1020 UHMWPE powder prior to compression molding into plate form. The plate is cross-linked by gamma-irradiation (50 kGy and 75 kGy respectively) before being heat-treated. The use of vitamin E is intended to improve the long-term stability of the UHMWPE by bonding with the free-radicals that may be left behind after the gamma-irradiation or cross-linking steps. The vitamin E which is mixed in at the powder stage has an affinity for these free-radicals and bonds with them before the free-radicals can bond with oxygen (oxidation) which shortens the UHMWPE molecule and damages the mechanical properties of the UHMWPE molecule.
BIOLOX® forte
The BIOLOX® forte hip heads are ceramic hip heads based on the ISO 6474-1 Type A.
Composition
element | mass fraction in % |
| Alumina (base material) | min. 99.7 |
| Magnesium oxide (sinter additives) | max. 0.2 |
| Impurities (SiO2 + CaO + Na2O) | max. 0.1 |
BIOLOX® delta
The BIOLOX® delta hip heads are ceramic hip heads based on the ISO 6474-2 Type X.
Composition
element | mass fraction in % |
| Alumina | 60 to 90 |
| Zirconia (ZrO2 + HfO2) | 10 to 30 |
| HfO2 in ZrO2 | max. 5 |
| Intended additives | max. 10 |
| Impurities | max. 0.2 |
Stainless Steel
Stainless steel for surgical implants complies with ISO 5832-1.
Chemical Composition
element | mass fraction in % |
| Carbon | max. 0.030 |
| Silicon | max. 1.0 |
| Manganese | max. 2.0 |
| Phosphorus | max. 0.025 |
| Sulfur | max. 0.010 |
| Nitrogen | max. 0.10 |
| Chromium | 17.0 to 19.0 |
| Molybdenum | 2.25 to 3.00 |
| Nickel | 13.0 to 15.0 |
| Copper | max. 0.50 |
| Iron | remainder |
Forged high embroidered stainless steel for surgical implants complies with ISO 5832-9.
Chemical Composition
element | mass fraction in % |
| Carbon | max. 0.08 |
| Silicon | max. 0.75 |
| Manganese | 2 to 4.25 |
| Nickel | 9 to 11 |
| Chromium | 19.5 to 22 |
| Molybdenum | 2.0 to 3.0 |
| Niobium | 0.25 to 0.8 |
| Sulfur | max. 0.01 |
| Phosphorus | max. 0.025 |
| Copper | max. 0.25 |
| Nitrogen | 0.25 to 0.5 |
| Iron | rest |
other:
individual max. 0.1
together max. 0.4
Stainless steel for cast and solution-annealed implants comlies with ASTM F 745 for the chemical composition.
Chemical Composition
element | mass fraction in % |
| Carbon | max. 0.06 |
| Silicon | max. 1.0 |
| Manganese | max. 2.0 |
| Nickel | 11.00 to 14.50 |
| Chromium | 16.50 to 19.00 |
| Molybdenum | 2.00 to 3.00 |
| Sulfur | max. 0.030 |
| Phosphorus | max. 0.045 |
| Copper | max. 0.50 |
| Nitrogen | max. 0.20 |
| Iron | balance |
| Ferrite Content | max. 1 |
EPORE®
EPORE® is a highly porous structure based on titanium alloy (TiAl6V4). The EPORE® structure is formed by additive manufacturing technology. The additive manufacturing process uses a powder-bed-based method, which is then turned into solid form using an Electron Beam Melting (EBM®).
Further information can be found under the following link:
https://www.implantcast.de/en/company/technology/additive-manufacturing-eporer/
Composition
element | mass fraction in % | |
ASTM F 3001 | ISO 5832-3 | |
| Aluminium | 5.5 to 6.5 | 5.5 to 6.75 |
| Vanadium | 3.5 to 4.5 | 3.5 to 4.5 |
| Iron | max. 0.25 | max. 0.3 |
| Oxygen | max. 0.13 | max. 0.2 |
| Carbon | max. 0.08 | max. 0.08 |
| Nitrogen | max. 0.05 | max. 0.05 |
| Hydrogen | max. 0.012 | max. 0.015a |
| Yttrium | max. 0.005 | - |
| other elements, each | max. 0.1 | - |
| other elements, total | max. 0.4 | - |
| Titanium | rest | rest |
a Excluded are blocks for which the maximum hydrogen content must be 0.010% (mass fraction).
other materials
- PET: Polyethyleneterephtalate
- PEEK: Polyetheretherketone