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Titanium 6% Aluminum
7% Niobium.
Second Edition
John Disegi
Second Edition
November 2008
About the Cover
A portion of the Periodic Table depicts various major implant
alloying elements.
Alpha and beta crystal structure of Ti-6Al-7Nb.
Acknowledgement
The author wishes to acknowledge the technical contributions of
Professor S. Steinemann, University of Lausanne, Switzerland.
Introduction
Basic Metallurgy
Properties
References
Glossary
Table of Contents
2
1. Composition 3
2. Microstructure 4
1. Physical 5
2. Tensile 6
3. Fatigue 7
4. Corrosion 8
5. Biocompatibility 11
6. Surface 12
13
16
2
Titanium 6% Aluminum 7% Niobium is a relatively new titanium
alloy that has been selected by Synthes for the next generation of ad-
vanced fracture fixation devices. The alloy was conceived in 1977 by a
team of researchers at Sulzer Bros., Winterthur, Switzerland.
1
The new alloy was introduced by 1985 following six years of intensive
development and testing. A total hip replacement (THR) prosthesis
fabricated from Ti-6Al-7Nb was originally marketed by Protek as
Protasul
A
/cm
2
9
but not Ti-6Al-4V, which exhibits a strong current increase for a pitting
potential of 6000 mV. Anodic polarization results confirm the improved
corrosion resistance of Ti-6Al-7Nb when compared to Ti-6Al-4V in a
reducing acid environment.
Pitting potential results
16
versus a Saturated Calomel Electrode (SCE) in
a severe reducing acid environment of 2 molar HCl at 37 C are shown
in the following graph.
Breakthrough results indicate that the pitting potential of Ti-6Al-7Nb
is above +10.0 volts which is identical to unalloyed titanium and
substantially better than the + 5.9 volts exhibited by Ti-6Al-4V alloy.
This suggests that the Ti-6Al-7Nb passive film is more resistant to
breakdown than the Ti-6Al-4V in an aggressive reducing acid
environment.
The corrosion fatigue strengths of Ti-6Al-7Nb and Ti-6Al-4V total
hip stems
17
have been compared by Semlitsch. Corrosion fatigue
strengths were similar when tested for 5 million cycles in Ringers
solution at 37 C and a frequency of 6 Hertz.
Exposure of Ti-6Al-7Nb alloy to sodium chloride, ferric chloride, and
amino acids
18
have shown that the alloy is chemically inert under the
test conditions investigated.
Samples have also been tested by four-point bend testing at 80% of
the 0.2% Y.S. in NACE TM0177-86 solution for 760 hours.
19
The test
solution is very aggressive and contains sodium chloride, glacial acetic
acid, and is saturated with bubbling hydrogen sulfide.
10
8
6
4
2
0
Pitting
Potential
(+ volts)
Ti6Al7Nb Ti6Al4V Ti
>10.0 >10.0
5.9
Pitting potential in 2 molar HCI at 37C
10
The specimen size was 70 mm x 10 mm x 2 mm. No cracked or failed
specimens were found after exposure to the NACE solution at 24 C
for 760 hours under high bending loads and very strong reducing
conditions.
Slow strain rate stress corrosion cracking (SCC) tendency has been
evaluated by constant extension rate testing in 3% NaCl or deionized
water at 40 C as reported by Simpson.
19
A material is considered to be susceptible to SCC if the ductility proper-
ties in an aggressive media (3% NaCl) are inferior to the properties in
a non-aggressive media (deionized water). Reduction of area or elon-
gation ratios for sodium chloride/water that are below 90% may
indicate SCC problems. Comparison of the results in NaCl with those in
water indicated no problem is to be expected with SCC because the re-
duction of area ratios were virtually identical regardless of the test envi-
ronment. This trend was also observed when the test was repeated at
a strain rate of 1 x 10
-6
sec
-1
and when the % elongation ratios were
used as a criteria.
Properties continued
76
74
72
70
66
64
62
60
Reduction
in Area (%)
Ti6Al7Nb Ti6Al4V
Deionized Water 3% NaCl
Constant extension rate
testing at 2 x 10
-7
sec
-1
11
5. Biocompatibility
In vitro organ culture tests evaluated the growth inhibition of organ
cultured embryonic rat femurs in the presence of soluble metal
chlorides for 10 days and solid metal implants for 7 days.
20
Results
indicated that vanadium salts are an order of magnitude more toxic
than nickel, cobalt, and copper salts. The same experiments were also
performed with niobium and aluminum oxide salts that were saturated
in the test electrolyte. No toxic reactions occurred.
21
No growth inhibition was observed in femurs with niobium and
titanium metal wire implants .
20
These metals were well tolerated as
evidenced by the appearance of normal cartilage cells near the wire im-
plants. However, other metals such as nickel, cobalt, copper, and iron
showed marked corrosion, growth inhibition, and cell damage. Alu-
minum metal was not tested in this study.
Work at Lausanne University, Institute for Experimental Physics,
22
has
concluded that the oxides or hydroxides of Ti, Al, and Nb are at
saturation in biological tissue. The dissolved metals will not be ionized
or transported in vivo. The elements in Ti-6Al-7Nb do not create a
bioburden and this accounts for the excellent localized biocompatibility
observed for this alloy.
In vivo screening tests
23
were performed with grooved cylinders
implanted subcutaneously in the backs of mice for 1, 3, and 9 weeks.
This test is identical to the subcutaneous screening method specified
in ASTM F 1408.
24
Histological analysis revealed that the Ti-6Al-7Nb
implants did not create adverse tissue tolerance reactions. The number
of giant cell nuclei was smaller for vanadium-free alloys.
Synthes bone screws machined from unalloyed titanium and various
titanium alloys were implanted in dog femora for up to 2 years.
25
Testing was performed according to ASTM F 981 standard.
26
Histologi-
cal evaluation indicated that direct bone attachment was observed
at the Ti-6Al-7Nb bone screw surface. Overall biocompatibility results
were excellent with no adverse cellular reactions observed histologi-
cally. Removal torques at 26 and 52 week retrieval periods were similar
for anodized screws fabricated from Ti-6Al-7Nb and Ti-6Al-4V. All
unalloyed titanium and titanium alloy screws evaluated in the study
demonstrated similar removal torque from dog femora bone.
Mechanically polished Ti-6Al-7Nb discs implanted in the backs of mice
27
were retrieved for histological and surface chemistry analysis at the
University of Lausanne. Desorption studies indicated that the amount
of adherent soft tissue was similar for Ti-6Al-7Nb and unalloyed
12
titanium implants. Visible corrosion products were not present on the
surface of the implants after the surrounding tissue was removed.
Retrieval analyses of human hip joint prostheses
28
have concluded
that Ti-6Al-7Nb is extremely biocompatible as evidenced by osseous
ingrowth at the implant surface. Histological examination indicated
that osseous tissue formation along the entire stem length provided
secondary implant stabilization.
6. Surface
The surface oxide of Ti-6Al-7Nb has been characterized
18
by X-Ray
Photoelectron Spectroscopy analysis. The surface study found the oxide
film was a mixture of TiO
2
, Al
2
O
3
, and Nb
2
O
5
. This study concluded that
the mixed oxide film formed on Ti-6Al-7Nb alloy is more chemically
stable than the TiO
2
oxide layer formed on unalloyed titanium.
Ti-6Al-7Nb implants may be shot peened for improved fatigue life but
the shot peening media must be carefully selected to avoid iron con-
tamination at the surface of the implant. Final surface treatment after
machining, or after machining and shot peening, consists of electro-
chemical anodizing, although nitric acid passivation may also be used.
29
Synthes Ti-6Al-7Nb implants have an anodized surface finish that is
produced by immersing the implants in an electrochemical solution for
a specified time and voltage. The color that is produced is a function
of the mixed oxide film thickness which is controlled in the anodizing
process. Visible light diffraction within the oxide produces a distinct
color. No pigments or organic coloring agents are present in the
anodized film. The standard Synthes anodizing treatment creates a
gold appearance that is a distinguishing feature of Synthes titanium
implants. The anodizing process is capable of creating a variety of
colors, depending on the thickness of the oxide film.
Surface analysis of anodized CP titanium
30
has shown that typical
anodizing treatments increase the oxide thickness and alter the
oxide chemistry. Corrosion studies concluded that the anodized film
exhibited reduced corrosion rates when compared to unanodized
specimens. Extrapolation of the CP titanium results suggest that
anodizing improves the corrosion resistance of the mixed oxide film
that is normally present on the surface of Ti-6Al-7Nb alloy.
Recent studies in aerated 3% sodium chloride
31
indicated that
anodized films on Ti-6Al-7Nb and other titanium alloys have higher po-
larization resistance than CP titanium. The results confirmed increased
stability and better corrosion resistance for an anodized oxide film in
a chloride-containing corrosive environment.
Properties continued
13
1. Surgical Implant Alloy IMI 367, Product Bulletin, IMI Titanium
Limited, Birmingham, England.
2. Steinemann, S., and Perren, S., Surgical Implant and Alloy for
Use in Making an Implant, U.S. Patent 4,040, 129, August 9,
1977.
3 Niobium, Product Brochure, Teledyne Wah Chang, Albany, OR,
pp. 3-4.
4. ISO 5832-11: Implants for Surgery Metallic Materials, Part II:
Wrought Titanium-6 Aluminum-7 Niobium Alloy, International
Organization for Standardization.
5. ASTM F 1295: Standard Specification for Wrought Titanium-6
Aluminum-7 Niobium Alloy for Surgical Implant Applications,
American Society for Testing and Materials, Philadelphia, PA.
6. AMS 2249C: Chemical Check Analysis Limits, Titanium and Tita-
nium Alloys, Society of Automotive Engineers, Warrendale, PA.
7. ASTM B 600, Standard Recommended Practices for Descaling
and Cleaning Titanium and Titanium Surfaces, American Society
for Testing and Materials, Philadelphia, PA.
8. Semlitsch, M., et.al., Titanium-Aluminum-Niobium Alloy,
Development for Biocompatible High Strength Surgical Im-
plants, Sonderduck aus Biomedizinische Technik 30, (1985), 12,
S. 334-339.
9. Technical Committee of European Titanium Producers, ETCC2
Monograph, IMI Titanium Ltd., Birmingham, England, Kynoch
Press.
10. Disegi, J., AO/ASIF Unalloyed Titanium Implant Material,
Second Edition, AO/ASIF Technical Publications, SYNTHES (USA),
July 1991.
11. Severn Engineering Company, Inc., Annapolis, MD.
12. Disegi, J., Internal Correspondence, SYNTHES (USA), Paoli, PA.
13. Disegi, J., Magnetic resonance imaging of AO/ASIF stainless
steel and titanium implants, Injury, AO/ASIF Scientific Supple-
ment, Vol. 23, Supplement 2, 1992.
14. Steinemann, S., et.al., Beta-Titanium Alloy for Surgical
Implants, Seventh World Conference on Titanium, San Diego,
CA, June 28-July 2, 1992.
15. Protasul