Tantalum for Surgical Implants
Specifications and Standards
Surgical grade (medical grade) tantalum – i.e. tantalum used in medical devices, is specified in a number of standards like:
- ASTM F560: Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400)
- ISO 13782: Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications.
- BS 7252-13: Implants for surgery — Metallic materials — Unalloyed tantalum for surgical implant applications
Where the British surgery standard BS 7252-13 is identical to the ISO 13782 standard.
The standards specify the chemical, mechanical, and metallurgical requirements for unalloyed tantalum used in orthopedic surgery or in the manufacture of implants. The material specifications in the standards are substantially similar.
Surgical Grade Tantalum Base Forms
A number of base forms are covered by the ASTM F560 standard.
ASTM F560 differentiates orthopedic grade tantalum products in the following way:
Tantalum plate is defined a flat product more than 0.1875 in. (4.7 mm) in thickness.
Tantalum sheet is flat products less than 0.1875 in. (4.7 mm) in thickness and more than 6 in. (152.4 mm) wide.
Tantalum strip is a flat product less than 0.1875 in. (4.7 mm) in thickness less than 6 (152.4 mm) in. wide.
Tantalum rod for surgery is defined as a material with a diameter between 0.125 to 2.5 in. (3.18 to 63.50 mm) supplied in straight lengths (round, hexagonal, or octagonal cross section). Commonly however the expression “rod” is used for straightened tantalum wire also below 0.125 in. / 3.18 mm. X-medics offer tantalum rod products as small as 0.500 mm.
Implantable Tantalum wire is defined as material up to 0.125″ (3.15 mm) in diameter.
Basic Surgical Tantalum Material Grades (R05200 vs R05400)
The ASTM F560 , ISO 13782 and BS 7252-13 specify two acceptable base grades:
Type R05200: unalloyed tantalum vacuum-arc melted or electron-beam melted ingots.
Type R05400: powder-metallurgy consolidated unalloyed tantalum.
There is no difference in the mechanical requirements of tantalum type R05200 and R05400. Concerning the chemical composition of the tantalum, slightly higher oxygen and hydrogen levels are accepted in R05400 surgical grade tantalum as compared to R05200 as can be seen below.
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Products for Implant manufacturing
Surgical RSA Procedures
- Methodology and Review
- RSA vs. Histology
- Cranial and Cranio-facial Growth Studies
- Study Growth of Diaphyseal Bones
- Fracture Studies
- Osteotomy
- Joint Kinematics
- Joint Stability Studies
- Prostheses Fixation Studies
RSA Marking products
- 0.3mm markers for RSA
- 0.5mm markers for RSA
- 0.8mm markers for RSA
- 1.0mm markers for RSA
- 1.6mm markers for RSA
Biocompatibility of Tantalum
Many studies demonstrate excellent biocompatibility in a variety of situations including, those applications involving bone surgery.
Chemical Composition Requirement of Surgical Grade Tantalum
Tantalum can be considered medical grade if the chemical analysis of the Ingot material fulfills these requirements. There are slight differences in the accepted criteria for R05200 and R05400 tantalum grades, as can be seen below.
Element | R05200 * | R05400 ** |
max % (m/m) | max % (m/m) | |
Carbon | 0.010 | 0.010 |
Oxygen | 0.015 | 0.03 |
Nitrogen | 0.010 | 0.010 |
Hydrogen | 0.0015 | 0.0015 |
Niobium | 0.10 | 0.10 |
Iron | 0.010 | 0.010 |
Titanium | 0.010 | 0.010 |
Tungsten | 0.050 | 0.050 |
Molybdenum | 0.020 | 0.020 |
Silicon | 0.005 | 0.005 |
Nickel | 0.010 | 0.010 |
Tantalum | balance*** | balance*** |
*) Electron-beam or vacuum-arc cast tantalum.
**) Sintered tantalum.
***) The percentage of tantalum is determined by difference and need not be determined or certified.
When supplying tantalum R05200 or R05400, the supplier shall provide a certification that the material was tested in accordance with the specification and met all requirements. A report of the test results shall be furnished to the purchaser at the time of shipment.
Chemical Composition additional Requirements
In addition to the requirements above the purchaser may request a report certifying the values of carbon, oxygen, nitrogen, and hydrogen as specified below for each lot of material supplied.
Element | R05200 * | R05400 ** |
max % (m/m) | max % (m/m) | |
Carbon | 0.020 | 0.020 |
Oxygen | 0.025 | 0.035 |
Nitrogen | 0.010 | 0.010 |
Hydrogen | 0.0015 | 0.0015 |
*) Electron-beam or vacuum-arc cast tantalum.
**) Sintered tantalum.
Mechanical properties of Surgical Grade Tantalum
The mechanical properties of the materials are to be evaluated as tensile strength and elongation. The specific parameter and test method depends on the form of tantalum metal (wire, strip, plate etc.) and can be found in the standards.
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