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).

Chemical Composition

element

mass fraction in %

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

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.

Chemical Composition

element

mass fraction in %

Grade 1 ELI Grade 1 Grade 2 Grade 3 Grade 4A and 4B

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)

Chemical 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.

Chemical 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.

Chemical 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.

Chemical 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

remainder

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/

Chemical 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

remainder

remainder

a Excluded are blocks for which the maximum hydrogen content must be 0.010% (mass fraction).

other materials

  • PET: Polyethyleneterephtalate
  • PEEK: Polyetheretherketone