Implant Materials.

Unalloyed Titanium.

Sixth Edition

John Disegi
Sixth Edition
November 2008

About the Cover

A portion of the Periodic Table depicts elemental titanium and
various major implant alloy elements.
Alpha crystal structure of unalloyed titanium.

Acknowledgement
The author wishes to acknowledge the technical contributions of
Professor O. Pohler, Oberdorf, Switzerland.

Table of Contents

Introduction

Basic Metallurgy

Properties

1. Composition

2. Microstructure

1. Physical

2. Tensile

3. Fatigue

11

4. Corrosion

13

5. Biocompatibility

16

6. Surface

17

Clinical Features

18

References

19

Glossary

23

Introduction

Titanium is the ninth most abundant element and the fourth most
abundant structural metal in the earths crust. Large deposits of rutile
and ilmenite ore are located in the United States, Canada, and Australia. Titanium metal producers have access to large raw material
reserves to ensure that the material requirements of the implant,
aerospace, chemical processing, and other critical industries will be
met in the future. A comparison of mineral reserves located in the
United States indicates that titanium is much more abundant than
other strategic minerals that are used to produce stainless steel and
cobalt base implant alloys.1
100
90
80
70
60
U.S. Mineral
Reserves (%)

50
40
30
20
10
0
Cobalt

Chromium

Nickel

Titanium

The United States mines about one-third of its titanium raw material
requirement. The balance is imported mainly from Australia.2
Titanium ore is treated with chlorine gas to produce an intermediate
titanium chloride product. The titanium chloride is reduced with either
magnesium or sodium metal to produce titanium metal granules. The
resultant granules are pressed into a dense compact, and the compacts
are welded together to form an electrode for vacuum melting. An
electric current is passed through the electrode in a vacuum arc furnace
to produce a titanium ingot. The ingot is normally double or triple
vacuum arc melted to yield extremely pure and homogeneous titanium
metal. The remelted ingot is further processed by conventional metalworking techniques to produce bar, wire, sheet, plate and tubular
products.3

Basic Metallurgy

1. Composition
Four grades of unalloyed titanium known as Commercially Pure (CP)
Grade 1, 2, 3, or 4 are available with a stable alpha phase microstructure. The primary difference in composition is related to oxygen
content. The strength of unalloyed titanium increases as the oxygen
content increases from Grade 1 through Grade 4. Small quantities of
nitrogen and carbon tend to stabilize the alpha phase. The composition
requirements of the four unalloyed titanium grades are precisely controlled and documented in ASTM F 67 specification for surgical
implant material.4
Composition limits are also specified for Grade 1 ELI (Extra Low Interstitial), Grade 1, Grade 2, Grade 3, and Grades 4A (annealed) and 4B
(cold worked) in the ISO 5832-2 international standard.5 The ISO limits
are slightly different than ASTM F 67 limits and have been compared
as follows:

Unalloyed titanium composition limits for bar product according to ASTM F 67 and
ISO 5832-2 specifications
Grade 1
ELI

Grade 1

Grade 2

Grade 3

Grade 4,
4A, 4B

Nitrogen,
max

0.012

0.03

0.03

0.05

0.05

Carbon,
max

0.03

0.08
0.10*

0.08
0.10*

0.08
0.10*

0.08
0.10*

Hydrogen,
max

0.0125

0.0125*
0.015

0.0125*
0.015

0.0125*
0.015

0.0125*
0.015

Iron,
max

0.10

0.20

0.30

0.30

0.50

Oxygen,
max

0.10

0.18

0.25

0.35

0.40

Ti

Balance

Balance

Balance

Balance

Balance

*ISO 5832-2 requirements for Grades 1, 2, 3, 4A and 4B

Basic Metallurgy continued

Flat product such as sheet, strip, and plate are identical in composition
except a maximum hydrogen content of 0.015% is specified for all
grades in ISO 5832-2.
Maximum hydrogen content of 0.010% must be met for billet in
ASTM F 67 and ISO 5832-2. A billet is defined as a solid semi-finished
section with a cross sectional area greater than 10322 mm2 whose
width is less than 5 times its thickness.
Hydrogen content must be kept very low in titanium compositions.
Titanium cleaning operations which use nitric-hydrofluoric acid solutions are carefully controlled to eliminate hydrogen absorption during
pickling. A ratio of 10 parts nitric acid to 1 part hydrofluoric acid is
recommended.6
Unalloyed titanium usually contains a residual amount of iron in the
form of TiFe.7 This intermetallic compound increases the solubility limit
of hydrogen but does not have a dramatic effect on mechanical properties.8 The influence of iron content on the corrosion resistance can be
significant.9
ASTM F67 and ISO 5832-2 specifications permit a maximum iron
content from 0.10% to 0.50% depending on grade. Synthes titanium
bar product is specified to a lower maximum iron content, for enhanced corrosion resistance when compared to industry standards.
Detailed information on the effect of iron content on corrosion
resistance is included in the discussion on page 14.

2. Microstructure
Unalloyed titanium microstructures do not contain nonmetallic inclusions due to the highly sophisticated double or triple vacuum melting
practices that are used. Metallographic examination at 100X magnification typically reveals a complete absence of nonmetallic inclusions.
ASTM F 67 does not define unalloyed titanium microstructural features
but ISO 56832-2 requirements include a grain size of 5 or finer and the
absence of inclusions or foreign phases when examined at 100X
magnification.
A fine grain size is generally desired to provide a good combination
of tensile strength, ductility, and fatigue strength. Synthes unalloyed
titanium products are produced to a fine grain size requirement for
enhanced implant fabrication response and to provide an optimum
combination of mechanical properties.
The microstructure of unalloyed titanium can be altered by various
metallurgical treatments. An annealed microstructure is obtained
by heating the material to a defined temperature of around 700C
followed by a specific cooling cycle. The annealed micro-structure
4

represents the softest or lowest strength condition. A metallurgical

process known as cold working can increase the strength of titanium
by deforming the material at room temperature.
Typical microstructures of Synthes titanium bar is shown in the series of
transverse photomicrographs at 100X magnification. The photomicrographs were provided by University of Mississippi Medical Center.

Annealed bar microstructure

Cold worked bar microstructure

The annealed bar material has an equiaxed alpha microstructure. This

consists of a polygonal structure in which individual grains have equal
dimensions in all directions. Equiaxed microstructures are usually developed by cold working followed by annealing above the recrystallization
temperature.1 This material exhibits a very fine grain size of ASTM 8.5.
The cold worked bar material exhibits an elongated alpha microstructure that results from unidirectional cold working. An elongated
alpha microstructure is typical of Synthes bar product that is used to
manufacture bone screws. The amount of cold work must be closely
controlled so that high strength and adequate ductility are obtained.
Unalloyed titanium is completely nonmagnetic and remains nonmagnetic after severe cold working operations. Grade 1 through Grade 4
compositions in the annealed or cold worked condition exhibit no
residual magnetism.

Properties

1. Physical
Two important physical properties of unalloyed titanium for implant applications are the density and modulus of elasticity. A comparison2 with
wrought implant quality 316L stainless steel, wrought Co-28Cr-6Mo alloy, and wrought Ti-6Al-7Nb shows the properties set forth in the table
below.
The density of unalloyed titanium is 57% the density of wrought 316L
stainless steel and about 53% the density of wrought Co-28Cr-6Mo
alloy. The low density of titanium yields a weight reduction of nearly
50% when implants of similar dimensions are compared. The weight
reduction represents a patient comfort factor especially for large sized
implants.
Modulus of elasticity, or Youngs modulus, is a physical property of a
material that describes the stress per unit strain in the elastic region.
A material with a high modulus of elasticity will transfer less stress from
the implant to the bone. This produces a condition known
as stress shielding, which is undesirable because osteoporosis may
develop and promote refracture of the bone when the implant is
removed.10 However, recent work11 suggests that necrosis at the bone
plate contact surface may be responsible for some of the clinical
observations previously attributed to stress shielding.
The modulus of elasticity of unalloyed titanium is 5556% of 316L
stainless steel and 4243% of wrought Co-28Cr-6Mo alloy. Increased
stress transfer to bone is desirable but modulus of elasticity properties
are less important for fracture fixation implants with relatively small
cross-sectional areas.

Material

Density
(gm/cc)

Modulus of elasticity in
tension (MPa x 1000)

Ti Grade 1

4.51

103

Ti Grade 2

4.51

103

Ti Grade 3

4.51

103

Ti Grade 4

4.51

104

316L Stainless Steel

7.95

186

Wrought Co-28Cr-6Mo

8.29

241

Ti-6Al-7Nb

4.52

105

2. Tensile
The tensile properties of unalloyed titanium are dependent on grade
and type of metallurgical processing. ASTM F 67 specification outlines
the minimum mechanical properties that must be met in the annealed
or softest condition as a function of grade and product form. ISO
5832-2 international standard also covers annealed mechanical properties for Grades 1 ELI, 1, 2, 3, 4A, and includes Grade 4B in the cold
worked condition.
The minimum tensile properties of unalloyed titanium Grades 1 ELI, 1,
2, 3, 4, 4A, and 4B, implant quality 316L stainless steel (ASTM F 138),
wrought Co-28Cr-6Mo alloy (ASTM F 1537), and Ti-6Al-7Nb alloy
(ASTM F 1295) bar product in the annealed condition have been
compared as follows:

Minimum tensile properties for annealed bar product corresponding to

industry standards

Material

Ultimate
tensile
strength
(MPa)

0.2%
yield
strength
(MPa)

Elongation
x 4D or 4W*
(%)

Reduction
of area**
(%)

Ti Grade 1 ELI

200

140

30

Ti Grade 1

240

170

24

30

Ti Grade 2

345

275

20

30

Ti Grade 3

450

380

18

30

Ti Grade 4

550

483

15

25

Ti Grade 4A

550

483

15

Ti Grade 4B

680

520

10

316L Stainless Steel

480

170

40

Wrought Co-28Cr-6Mo

897

517

20

20

Ti-6Al-7Nb

900

800

10

25

* Alternatively, a gauge length of 5.65 So, where So is the original cross-sectional area, may be used
** Not specified in ISO 5832-2 or ASTM F 138
Cold worked condition

Properties continued

The minimum tensile strengths of unalloyed titanium Grades 3, 4, and

4A in the annealed condition are similar to 316L stainless steel, and
the minimum yield strengths are superior to 316L stainless steel in the
annealed condition. The minimum yield strength of Grade 4B is similar
to Co-28Cr-6Mo alloy.
Moderately to highly stressed implants are normally fabricated from
cold worked material. Cold worked implant quality 316L stainless steel
bar must meet a minimum UTS of 860 MPa and a minimum elongation
of 12%. CP titanium Grade 4B in the cold worked condition must
meet a minimum UTS of 680 MPa and a minimum elongation of 10%
according to ISO 5832-2. ASTM F 67 also specifies that grades may be
cold worked but a minimum 10% elongation must be met. Titanium
can be cold worked to produce high tensile properties that are nearly
equivalent to cold worked 316L stainless steel. Refined titanium compositions and unique metallurgical processing have been developed
by the Synthes group to increase the stress resistance of unalloyed
titanium.12
The minimum tensile strength and minimum elongation for selected
grades of conventional CP titanium are compared to Synthes unalloyed
titanium in the diagram below.
The mechanical property diagram reveals that the minimum tensile
strength of Synthes unalloyed titanium is significantly greater than
conventional industry grades. Higher strength capabilities and excellent
ductility are achieved with Synthes unalloyed titanium because of the
specialized metallurgical processing that has been developed.

Minimum Tensile
Strength (MPa)

900
800
700
600

Synthes

500
400

Industry
8

10

12

14

Minimum Elongation (%)

16

18

20

Certain small diameter Synthes 316L stainless steel implants such as

Kirschner wires, Steinmann pins, and Schanz screws are produced to
a very high tensile strength that exceeds 1,350 MPa to resist bending
deflection.12 Unalloyed titanium is generally not capable of attaining
extremely high levels of tensile strength. Consequently, these small
diameter Synthes implants are also available in Ti-6Al-4V or Ti-6Al-7Nb
alloy with a moderately high tensile strength of around 920 MPa.
ASTM F 67 requirements for UTS, minimum 0.2% yield strength, and
minimum elongation are identical for bar, wire, sheet, strip, and plate.
Additional mechanical property requirements for unalloyed titanium
sheet, strip, and plate include maximum 0.2% yield strength, minimum
bend test values, and property limits applied to the transverse and
longitudinal directions. A billet is defined as material with a forged
cross-sectional area >10,322 mm2 whose width is less than five times
the thickness. Mechanical properties of billets shall be negotiated
between the manufacturer and the purchaser. ISO 5832-2 has similar
bend and tensile property requirements for annealed Grade 1, 2, 3,
and 4A but does not specify a maximum 0.2% yield strength for sheet
and strip. These additional properties are not specified for implant
quality 316L stainless steel, and Co-28Cr-6Mo alloy is not capable
of being manufactured in sheet or strip form. The maximum 0.2%
yield strength and bend test requirements for unalloyed titanium
sheet, strip, and plate according to ASTM F 67 industry standard are
specified below:

Additional mechanical property requirements for unalloyed titanium sheet, strip, and
plate in the annealed condition
Bend test mandrel diameter (mm)
ASTM F 67
grade

Maximum 0.2%
yield strength (MPa)

Under 1.8 mm
thick

1.8 mm to 4.75 mm
thick

310

3T*

4T

450

4T

5T

550

4T

5T

655

5T

6T

*T = the thickness of the bend test specimen

Properties continued

Maximum yield strength and bend test requirements ensure that

titanium flat mill products can be fabricated into various implant
shapes in both the transverse and longitudinal planes. The bend test
criteria is also a measure of good formability, since the material must
be free of cracks after bending to the required radius.
The composition, grain size, and fabrication of Synthes sheet is tightly
controlled to provide maximum ductility for exceptional bone plate
contourability.
ASTM F 67 also specifies tensile property requirements for annealed
wire sizes. Wire diameters 3.18 mm are identical to annealed bar
product. Ultimate tensile strength for annealed wire sizes <3.18 mm
are also the same as for annealed bar product. The major differences
for annealed wire sizes less than 3.18 mm diameter are related to
minimum 0.2% yield strength, minimum elongation, and the absence
of reduction of area requirements as follows:

Minimum yield strength and elongation requirements for annealed titanium wire
< 3.18 mm diameter

Diameter (mm)

Grade

Yield strength
(0.2% offset),
MPa

<3.18 to 1.58, incl.

1
2
3
4

170
275
380
483

15
12
10
8

<1.58 to 0.51, incl.

1
2
3
4

---------

12
10
8
8

<0.51 to 0.13, incl.

1
2
3
4

---------

10
8
6
4

Elongation %

Size variations and out-of-round tolerances are also compiled for wire diameters < 3.18 mm in ASTM F 67.

10

3. Fatigue
Fatigue is defined as the process of progressive, permanent structural
change occurring in a material that is subjected to alternating stresses
and strains.13 The alternating stress and strain effects are usually localized and may produce cracks or complete fracture after a sufficient
number of cycles. Unalloyed titanium fatigue life, or number of loading
cycles sustained before failure, is influenced by many factors including
composition,14 grain size,15 processing history,16 surface\finish,17 residual
surface stress,18 and ultimate tensile strength.19 Major test dependent
variables include type of alternating load (rotating-beam; plane bending; tension-compression), specimen geometry, frequency, and test
environment.
Fatigue testing of orthopaedic implants is generally performed at a
low frequency of 35 cycles/sec and may include a 0.9% saline or
biological test environment. This is somewhat different than the test
procedures typically used for fatigue characterization of bar and sheet
product. Because of the complexity of fatigue testing, only a brief
overview will be presented.
The following data documents the plane bending fatigue data of unnotched, 1.0 mm thick unalloyed titanium sheet as a function of tensile
strength:
Plane bending fatigue data for unnotched 1.0 mm thick unalloyed titanium sheet19
Ultimate tensile
strength (MPa)

Condition
Annealed

Cold rolled

Plane bending
fatigue strength (MPa)

371

246

402

235

432

284

468

284

510

265

667

314

667

343

745

334

766

343

772

383

820

383

Frequency: 58 cycles/sec

Test Environment: Air

11

Properties continued

The fatigue strength is the maximum stress that can be sustained for a
specific number of cycles without failure, the stress being completely
reversed within each cycle unless otherwise stated. The plane bending
fatigue strength of the 1.0 mm unalloyed titanium sheet increases as
the ultimate tensile strength increases. The fatigue strength varies between 4566% of the UTS, and this index is known as the endurance
ratio.
Many metallurgical factors and specific test variables exert a strong influence on the fatigue strength that is obtained for implant materials.
The fatigue properties of unalloyed titanium, implant quality 316L
stainless steel, and a wrought cobalt base implant alloy have been
documented .20 In this study, Grade 3 titanium had a higher fatigue life
than 316L stainless steel in the low load range. The fatigue results
were highly dependent on loading conditions.
The endurance limit is the maximum stress below which a material can
presumably endure an infinite number of stress cycles. Comparative
fully reversed flexural fatigue results for various implant materials have
been compiled 21 as follows:

Typical fully reversed flexural fatigue results for various

implant materials
Endurance limit at
Material

Condition

10 7 cycles (MPa)

CP Ti

Annealed

241 379

316L Stainless Steel

Cold worked

310 448

Co-Cr-Mo

Cast

241 310

Ti-6Al-4V

Annealed

379 448

12

4. Corrosion
The superior corrosion resistance of unalloyed titanium and titanium
alloys compared to iron or nickel based implant alloys is well documented in the literature. 22 The referenced study measured the anodic
polarization behavior of a number of implant materials versus a Saturated Calomel Electrode (SCE) in a physiological solution. Tabulated
corrosion results as follows:
Breakdown potential for implant metals in Hanks solution at 37C

Breakdown
Potential
(Volts)

2.4
2.0
1.6
1.2
0.8
0.4
0
316L

Co-Cr-Mo

Ti-6Al-4V

Ti

Corrosion resistance increases as the anodic breakdown potential

increases. The results indicate that titanium has superior corrosion
resistance by a large margin over the other implant materials that
were tested .22
R. Solar has also studied the corrosion resistance of titanium 23 and
concluded that titanium and some of its alloys may be the most
biocompatible and corrosion-resistant metallic implant materials in
present use.
Titanium readily forms a passive surface film which provides a high
degree of immunity against attack by most mineral acids and 2 chlorides. The ability of a passive film to repassivate readily if the film is
scratched, abraded, or disrupted is considered an important feature
of any highly corrosion resistant material. Repassivation studies have
shown that the surface oxide film on titanium is much more stable
than 316L stainless steel or Co-Cr-Mo alloy. 22
A low iron content in the unalloyed titanium microstructure has been
shown to improve the stability of the protective oxide film. Unalloyed
titanium with a low iron content of 0.020% has demonstrated a 40%
increase in anodic breakdown potential in 3.5% sodium chloride at
25C when compared to a composition containing 0.150% iron.
13

Properties continued

Iron contamination on the surface of titanium or the presence of iron

in the titanium microstructure can also decrease the corrosion resistance in reducing acids. Accelerated laboratory tests have documented
the effect of microstructure iron content on the corrosion rate in reducing acid solutions as follows. 9
Effect of iron content on the corrosion rate of unalloyed titanium in 10% HCl at 21C

Corrosion
rate
(gm/m2/hr)

0.20
0.15
0.10
0.05
0.00
0.02

0.06

0.10

0.14

Iron Content (%)

For many materials, localized corrosion may occur within crevices and
small cavities on metal surfaces exposed to aggressive solutions containing dissolved oxygen and chloride ions. The data below compares 316L
stainless steel with unalloyed titanium Grade 2 under accelerated
exposure conditions .24
Crevice corrosion resistance in geothermal brine with 100 ppm
oxygen at 232C for 15 days
Material
316L Stainless Steel
Ti Grade 2

Corrosion Rate (micrometer/year)

6200
0

The results demonstrate the excellent corrosion resistance of titanium

in an accelerated crevice corrosion environment. No crevice corrosion
was detected for the Grade 2 titanium, while severe crevice corrosion
was measured for the 316L stainless steel.
Fretting corrosion is a form of corrosion that can occur when the
protective passive film is mechanically disrupted as a result of fretting
or abrasive action. This type of corrosion is frequently encountered
with implant screws and plates due to the relative motion between
the underside of the screw head and the contact surface of the plate.
Analysis of retrieved Synthes titanium implants has shown that no
14

0.18

microscopically visible corrosion attack is detectable between screw

heads and plates. Only mechanical wear and oxidized wear particles
are found. 25 In vitro fretting results at room temperature have been
reported for plates and screws 26 when tested according to ASTM
F 897 test procedure:
Fretting volume loss in 0.9% saline solution after 14 days
Fretting volume loss (mm3)
Material

Plate

Screws

Total

Ti

0.018 0.004

0.016 0.009

0.040 0.016

316L Stainless Steel

0.138 0.050

0.122 0.038

0.260 0.075

The weight loss results in the referenced study have been converted to
fretting volume to account for the density differences. Each screw and
each two-hole plate was individually weighed, in addition to each three
component combination. Hence, there is a slight difference between
plate + screw cumulative volume loss and total plate/screw volume
loss. The fretting resistance of the titanium plates and screws was
superior to 316L stainless steel plates and screws in this study under
accelerated laboratory fretting conditions.
An accelerated form of corrosion known as galvanic corrosion can
occur in a mixed metal system due to the difference in the electrochemical potential between the two materials. Emergency clinical situations may be encountered that may require the use of 316L stainless
steel and unalloyed titanium for multicomponent device applications.
Consequently, a clinical study was conducted with Synthes implant
quality 316L stainless steel screws and Synthes unalloyed titanium bone
plates. 27 No clinical disadvantage was observed in the study for this
specific combination of implants.
The extent of galvanic corrosion that may be experienced with a mixed
metal system is difficult to predict on the basis of values extracted from
the electromotive series. This is highlighted in a report by Kruger 28 that
states Even if one uses a more relevant series of potentials, there is
no assurance that one can reliably predict the extent of corrosion
caused by a bimetallic couple. Solar concluded that implant quality
316L exhibited multiple pitting in all tests when coupled with itself, a
titanium alloy, or cast Co-Cr-Mo .23 According to Solar, similar results
were obtained by Levine and Staehle who concluded problems can
occur with any of the widely used metals, however, especially if metals
are mixed. Galvanic corrosion effects are also dependent on the relative ratio of the anodic to cathodic areas.
15

Properties continued

The mixing of unalloyed titanium with implant quality 316L stainless

steel should be avoided to eliminate any possibility of galvanic corrosion
or accelerated fretting corrosion. Many of the advantages of unalloyed
titanium such as improved corrosion resistance, improved biocompatibility, and absence of allergic response may not be realized with a mixed
metal system. The possibility of increased product liability exposure must
also be considered when a mixed implant system is used.

5. Biocompatibility
As early as 1940, Bothe and colleagues concluded that unalloyed titanium pegs were well tolerated in an animal model and the biocompatibility was similar to stainless steel or Co-Cr-Mo alloy. 29 Leventhal worked
with rabbits and rats and reported in 1951 that titanium was inert and
appeared to be ideal for fraction fixation. 30 Brunski concluded that good
tissue response was obtained when pure titanium dental implants were
evaluated in beagle dogs. 31 Organ culture studies at the Laboratory
for Experimental Surgery. 32 have demonstrated the excellent growth
development of embryonic rat femora implanted with titanium rods.
A study by Williams and Meachim 33 involved a large series of retrieved
human implants during the period of 1967 to 1972. No corrosion was
noted in any of the 49 titanium implants but 54% (64 out of 119) of the
stainless steel implants exhibited varying degrees of corrosion.
About 90% of the endosteal implants inserted worldwide are titanium
and Weiss has reported that unalloyed titanium dental implants are
being used routinely with clinical success. 34
Metal sensitivity reactions must also be considered. Dobbs and Scales
have reported that to their knowledge there are no reports which suggest that metal sensitivity or adverse reactions of any kind are associated
with titanium implants.35 This is in contrast to various clinical studies
which have shown that metal sensitivity reactions have been observed
with 316L stainless steel and Co-Cr-Mo implants. Preoperative patch
testing of 212 patients undergoing total hip replacement indicated that
6.6% were sensitive to nickel, cobalt, and chromium .36 There was some
indication that metal sensitivity was provoked in four patients after implantation. A more sophisticated metal sensitivity test known as leukocyte migration has shown 18% sensitive to nickel, 15% sensitive to
cobalt, and 3.5% sensitive to chromium in a study with 629 patients. 37
Synthes unalloyed titanium implants are recommended in situations
where metal sensitivity is preoperatively verified or where 316L stainless
steel implants have provoked an allergic patient response.
Unalloyed titanium also exhibits unique biocompatibility properties
which include soft tissue and bone adhesion to the titanium surface.38, 39
16

The bonding of biomolecules to the titanium surface has been analyzed

by sophisticated analytical techniques.40 Branemark has documented
the direct apposition of bone to unalloyed titanium dental implants in
a 15 year follow-up study.41 A major advantage of tissue integration at
the surface has been the possibility of less bacterial colonization and
reduced infection.42
Synthes titanium implants have been used for fracture treatment of over
5000 cases since 1966. Excellent biocompatibility has been clinically
observed in this large patient population. 25

6. Surface
Titanium that is exposed to air or water spontaneously forms a titanium
oxide film which is about 0.5 to 0.6 nanometers thick .43 A nanometer
is an extremely small unit of length equal to 1 x 10-9 meter. The exceptional stability and corrosion resistance of this passive layer has been
previously discussed.
Synthes unalloyed titanium implants are chemically treated in an electrolytic process known as anodizing to increase the thickness of the
naturally occurring titanium oxide film. The anodized film consists of
titanium oxide and is about 4060 nanometers thick. Various colors can
be produced in the anodizing process and this is a function of the oxide
thickness. Light interference within the oxide film is responsible for the
color that is obtained. Standard Synthes titanium implants are anodized
in a manner that creates a consistent and reproducible gold appearance,
although other colors can be produced.
Iron contamination may be present on the titanium surface as a result
of the implant machining or fabricating operations. Corrosion pitting
failures have been attributed to this type of surface contamination. 2
The chemical conditioning treatments that are a part of the anodizing
process remove surface contaminants that may be present from the
various manufacturing operations.
Rahn and coworkers 44 have investigated the relative amount of tissue
growth on Synthes titanium discs. The results indicated that mechanically polished, chemically polished, and anodized surfaces promoted similar animal cell growth patterns. It is expected that similar cellular
adhesion properties would be obtained for these relatively smooth
titanium surfaces.
The color readily distinguishes Synthes titanium implants from Synthes
316L stainless steel implants and this is considered an additional benefit
derived from the anodizing treatment. The gold appearance is aesthetically appealing, and the implants display reduced external visibility when
epidermal coverage is minimal.
17

Clinical Features

Synthes unalloyed titanium implants offer major clinical advantages which have been
summarized as follows:
Features and clinical advantages of Synthes unalloyed titanium implants
Material feature

Clinical advantage

Excellent corrosion resistance

Permanent implants

Unique biocompatibility

Tissue attachment for enhanced fixation

Nonallergenic

Complete absence of metal sensitivity

Low density

Lightweight implants

Good ductility

Easily contoured

Four grades

Implant design versatility

Sterilization
Implants may be sterilized by any of the standard methods such as
steam autoclave, ETO, gamma radiation, electron beam, and RF
discharge.

Implant handling
Excessive fingerprint contamination from handling may produce slight
discoloration after repeated steam autoclave cycles. No adverse effects
are related to this change in surface appearance.

Diagnostic imaging
X-radiography, Magnetic Resonance Imaging, CT Scans, and PET scans
can be utilized. MRI scan resolution is superior to 316L stainless steel
because titanium produces less starburst, or signal interference.

Implant retrieval
Occasional black deposits (wear debris) may be observed at implant removal sites. No adverse tissue reaction is associated with this clinical
observation. 35

18

References

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19

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Niles, OH.

20

25. Pohler, O., Stratec Medical, Waldenburg, Switzerland,

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37. Merritt, K. and Brown, S., Biological Effects of Corrosion

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Sons Ltd., 1982, pp. 3944.

22

Glossary

ALLOY. A metallic substance composed of two or more elements at

least one of which is metal.
ALLOYING ELEMENT. An element, added to and remaining in a
metal, that changes the metals structure and properties.
ALPHA. The low-temperature form of titanium with a hexagonal
close-packed (hcp) crystal structure.
ANNEALING. A metal-softening operation in which the metal is
heated to and held at a specified temperature, followed by cooling at
a controlled rate.
ANODIC REACTION. An oxidation reaction that produces electrons
at the anode of an electrochemical cell. When dissimilar metals are
coupled, the anode usually experiences increased corrosion.
ANODIZING. An electrolytic process that increases the thickness of
the protective oxide film on titanium.
BETA. The high-temperature form of titanium with a body-centered
cubic (bcc) crystal structure.
BETA TRANSUS. The temperature which designates the alpha-tobeta phase transformation of unalloyed titanium.
BODY-CENTERED CUBIC. A unit cell which consists of atoms
arranged at cube corners with one atom at the center of the cube.
BRITTLENESS. The tendency of a material to fracture without first
undergoing significant permanent deformation.
CATHODIC REACTION. A reduction reaction that consumes electrons
at the cathode of an electrochemical cell. When dissimilar metals are
coupled, the cathode usually undergoes reduced corrosion.
COLD-WORKED MICRO-STRUCTURE. A microstructure resulting
from cold working the material.
COLD WORKING. Permanently deforming a metal or alloy at room
temperature to increase its strength.
CRYSTAL. A solid composed of atoms that repeat in a pattern of
regular intervals in three dimensions.
DESCALING. Chemically or mechanically removing the thick oxide
layer that is formed on metals during high temperature processing.
DUCTILITY. The ability to permanently deform before fracturing.
ELECTRODE. A cylindrical metal compact that is suitable for vacuum
arc melting or a metal ingot that is suitable for remelting.

23

Glossary continued

ELONGATED ALPHA. A fibrous type of microstructure that results

from unidirectional cold working of unalloyed titanium.
ELONGATION. A term that describes ductility by measuring the
amount of extension that a material undergoes during tensile testing.
EQUIAXED STRUCTURE. A micro-structure feature that consists of
polygonal shaped grains with equal dimensions in all directions.
FATIGUE. The phenomenon leading to fracture under repeated or
fluctuating stresses having a maximum value less than the ultimate tensile strength of the material.
FATIGUE LIFE. The number of cycles of stress or strain of a specified
character that a given specimen sustains before failure of a specified
nature occurs.
FATIGUE STRENGTH. The maximum stress that can be sustained for
a specific number of cycles without failure, the stress being completely
reversed within each cycle unless otherwise stated.
FRETTING CORROSION. An accelerated form of corrosion that can
occur when the protective passive film is mechanically abraded. The
relative motion of the underside of a bone screw head with the contact
surface of a bone plate is a typical example.
HEXAGONAL CLOSE-PACKED. A unit cell which consists of a hexagonal arrangement of atoms in a plane surrounding an atom followed
by three atoms in the next horizontal plane.
HOT-WORKED MICRO-STRUCTURE. A microstructure resulting from
hot working the material.
HOT WORKING. Permanently deforming metal at an elevated temperature that is usually above the recrystallization temperature.
INCLUSION. A particle of foreign material in a metallic microstructure
that is usually considered undesirable.
INGOT. A metal casting that is suitable for remelting or hot working.
INTERMETALLIC COMPOUND. A phase in an alloy system that has a
well-defined composition and limited solubility.
LONGITUDINAL. Parallel to the principle direction of hot or cold
working.
MICROSTRUCTURE. The structure of metals as revealed by microscopic examination of a specimen.
MODULUS OF ELASTICITY. A measure of the stress per unit strain in
the elastic region before permanent deformation occurs.

24

NANOMETER. An extremely small distance equal to 1 x 10-9 meter.

PASSIVATION. The process of changing the chemical activity of a
metal surface to a less reactive state, usually to increase the corrosion
resistance.
PICKLING. Chemical removal of the thick oxide layer that is formed
on metals during high temperature processing.
POLYGONAL STRUCTURE. A closed planar shape bound on at least
three sides.
RECRYSTALLIZATION. A change from one crystal structure to
another that occurs during heating or cooling through a critical
temperature range.

REDUCTION IN AREA. A tensile testing measure of ductility that

equals the original area minus the area after fracture divided by the
original area, expressed as a percentage.
SOLUBILITY. A measure of the amount of a substance that can be
dissolved in a metal or alloy.

STRAIN. Change in length per unit length in the direction of the

applied stress.

STRESS. Force per unit area.

TRANSVERSE. Perpendicular to the principle direction of hot or
cold working.

TWINNING. A microstructure feature that describes mirror image

positions across a planar interface.
ULTIMATE TENSILE STRENGTH.
In tensile testing, the maximum load at fracture divided by the original
cross-sectional area.

UNALLOYED TITANIUM. Single phase titanium metal that does

not contain major alloying additions.

VACUUM ARC REMELTING. A melting process in which an electric arc is used to remelt an electrode inside a vacuum chamber.
YIELD STRENGTH. In tensile testing, the stress at which the
stress-to-strain ratio exhibits a specified deviation, usually designated
as 0.2% offset.

25

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