Download BIOLOX® FAMILY THE FUTURE IN YOUR HAND

CeramTec Medical Engineering
BIOLOX® FAMILY
THE FUTURE IN YOUR HAND
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TECHNICALLY AND CLINICALLY PROVEN
CeramTec: More than 100 years in ceramics,
40 years in medical technology
In most cases, they are as invisible as they are indispensable –
CeramTec ceramic products are used worldwide for key appli­
cations in medical devices, automotive industry, electronics,
cutting tools, mechanical engineering and the chemical industry.
We have always focused on the consistent development of new
materials, high quality standards, specific system solutions and
constant dialog with our customers.
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WORLD MARKET LEADER IN
CERAMIC HIP COMPONENTS
Today, ninety percent of implant manufacturers purchase
their ceramic components for hip replacement from
CeramTec. The extremely wear resistant femoral ball
heads and cup inserts have been implanted over eight
million times throughout the world. No other material
from any manufacturer is used as frequently for bearing couples as the components of the BIOLOX® family.
Today, they are being implanted every 45 seconds. In
Europe, they are used in approximately 50 percent of
patients.
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Dental ceramics
Their superior biocompatibility, hydrothermal stability, strength and, not
least, their natural aesthetics make
ceramic materials the natural choice
for use in dental medicine. CeramTec
has over 20 years of experience in
this field and offers a broad range
of materials and manufacturing processes for dental products.
Hip implants
The excellent wear resistance and
outstanding biocompatibility make
ceramic inserts an ideal solution not
only for active patients, but also for
patients with metal hypersensitivity.
The ceramic-on-ceramic bearing
couple is by far the least susceptible
to wear of all bearing couples used
in total joint replacement surgery.
Knee implants
Components made of BIOLOX® delta
are also used in knee arthroplasty.
Their outstanding biological and
mechanical properties make them
the ideal implant, particularly for
patients with metal hypersensitivity.
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MATERIALS FOR PARTICULARLY
CHALLENGING APPLICATIONS
The wide range of ceramic components
in medical devices
For many decades, components for medical devices have been produced in various
business divisions of CeramTec, including piezo-ceramic elements and specially
developed high performance materials. Their particular properties ensure improved
function, greater durability and superior reliability.
Dental scalers
LED lighting
Endoscopes
A piezo-ceramic transducer induces
CeramCool components provide
High purity alumina is bioinert and
resonant oscillation in the tool. A high
efficient cooling for high energy
possesses excellent mechanical
oscillation frequency and micrometer
LED lighting technology. They
properties. These are important
amplitudes ensure that tartar is removed
permit ideal lighting conditions in
advantages for components being
thoroughly without damage to the
clinical settings.
used in endoscopic instruments.
Surgical knives
Various components
Ultrasonic nebulizers
The device operates on the same
Ceramic seal discs, valves, bearings and
For respiratory diseases, piezoelectric
principle as the dental scaler. With
bearing rings are used in a broad range of
ultrasound nebulizers permit the
the oscillating scalpel blade the
medical device applications. Ceramaseal®
precise dosing of medications and
surgeon can make precise incisions
vacuum sealed ceramic-on-metal compo-
the accurate setting of droplet sizes.
with minimal force and preserve
nents are used in the fields of analytics
the surrounding tissue.
and sensor technology.
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tooth.
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HIGH PERFORMANCE CERAMICS
This term covers a variety of highly specialized ceramic materials. They
are inorganic, non-metallic and excel with their unique mechanical,
electrical, thermal, biological and chemical properties.
By combining defined base materials and precisely adjusting specific
microstructures, it is possible to steer mechanical and physical parame­
ters in various directions. Ceramic materials are bioinert; there have
been no reported allergic reactions. They are extremely strong and
provide unique surface properties.
Lithotripters
Piezo-ceramics make it possible to
break up kidney and gall stones using
ultrasonic shockwaves. The focusing and precise targeting of the piezo
transducers ensure that surrounding
tissue remains unharmed.
Technology specialists
Specialists in piezo technology:
Phone: +49 9123 77 563
e-mail: [email protected]
Specialists in electronic components:
Phone: +49 9231 69 371
e-mail: [email protected]
Specialists in system components:
Phone: +49 9123 77 370
e-mail: [email protected]
Specialists in mechanical components:
Phone: +49 7153 611 444
e-mail: [email protected]
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Dental
Biologically safe materials allow for
metal-free care meeting the highest
aesthetic standards. We are working on
the development of a comprehensive
technology platform for ceramic dental
implants.
Spine
Unlike plastics and metal, ceramic implants
can be visualized in both radiographs and
MRI clearly and without artifacts. Their
hardness and defined surface properties
are added benefits.
Shoulder and small joints
As with hip arthroplasty, the use of
ceramic components in bearing couples
can significantly reduce wear, minimizing the risk of aseptic loosening. The
physical properties of ceramics can also
improve tribological behavior in shoulders and small joints.
Trauma
Preventing metal hypersensitivity and
reducing the risk of infection: in these
respects, ceramic or ceramic coated
implants can offer new solutions and
help reduce complications. The thermal
behavior of ceramics in the body also
increases patient comfort.
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CERAMTEC MEDICAL ENGINEERING
Innovations for better medical care
Our customers from the medical devices industry are constantly
asking us about new capabilities and uses of bioceramics: the most
urgent requests are for wear debris reduction, improving imaging,
preventing microbial contamination and providing options for pa­
tients with hypersensitivity to metals. Bioinert ceramic components
offer proven and potential approaches to solving these problems.
They are the focal point of our research and development. The goal
of CeramTec Medical Engineering is to create ceramic products for
new medical treatment options.
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BIOCERAMICS SURVEY
CeramTec surveyed practicing surgeons in various specialties to identify which new applications for bioceramics
were of particularly great interest to them. Based on
the proportion of those who checked the “very interested” box, the list of applications in order of priority
is as follows:
• Trauma implants (72%)
• Dental implants and instruments (70%)
• Implants for small joints (64%)
• Spinal implants (49%)
• Surgical instruments (31%)
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BIOLOX®forte
BIOLOX® delta
3Y zirconia
Millions of joint replacement compo-
This advancement on BIOLOX forte pos-
Zirconia (ZrO2) has the highest crack
nents made of BIOLOX®forte help people
sesses the same outstanding biocompat-
resistance of the ceramic materials.
across the world achieve a better quality
ibility as its predecessor. The base mate-
The manufacture of these components
of life. The classical high performance
rial is still alumina. However, its strength
requires the use of stabilizers, such as
material made from alumina (Al2O3)
and fracture toughness are more than
yttrium oxide, which make it possible
has been used in hip arthroplasty since
doubled as a result of the addition of
to achieve strengths of over 1600 MPa.
1995 and serves as a benchmark for
the oxides and ceramic platelets. This has
As is the case with BIOLOX® delta, cracks
the evaluation of ceramic materials in
made it possible to offer components
are prevented from spreading by what
medical devices worldwide. The proven
in additional sizes and it addresses new
is known as conversion reinforcement.
strengths of the material include its
applications such as knee arthroplasty.
Zirconia can be used to make sharp
excellent biocompatibility, outstand-
BIOLOX delta is an alumina matrix
edges, which together with its visual
ing mechanical properties and its high
composite.
characteristics make the material also
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degree of chemical and hydrothermal
ideal for dental medicine.
stability.
2 µm
Microstructure of BIOLOX®delta
2 µm
Microstructure of
yttrium stabilized zirconia
10 µm
100 µm
Microstructure of silicon nitride
5 µm
Microstructure of ATZ
2 µm
Microstructure of BIOLOX®forte
Indenter impression
in Ce zirconia
Ce zirconia
Silicon nitride
ATZ
Cerium oxide (Ce2O3) can also be used
The high level of dynamic fracture
Alumina toughened zirconia (ATZ) con-
as a stabilizer for zirconia. With an op-
toughness and extraordinary edge
sists of the same ceramic constituents
timal crystalline structure, this material
strength make this non-oxide ceramic
as ZTA, but with zirconia as the basic
achieves an even higher level of fracture
a special material. For example, even
material. Of all of the ceramic materials,
toughness. It also permits limited plastic
iron materials can be cut with compo-
it possesses the highest flexural strength
deformation, similar to metal. Conversely,
nents made from silicon nitride (Si3N4).
(approximately 1700 MPa) and is there-
the strength and hardness are lower
Its specific qualities make it an inter-
fore used, for example, in tools subjected
than is the case with 3Y zirconia. With
esting material for numerous types of
to high levels of stress. ATZ drilling and
its additional increased elasticity, this
medical device applications.
milling heads are already used in dentistry
material can also serve as an alternative
when preparing for dental prostheses.
for trauma implants – either as base ma-
That way metal contact with the area
terial or coating, for example in patients
of the implant can be avoided completely,
with a hypersensitivity to metal.
when ceramic dental prostheses are
being used.
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THE BIOLOX FAMILY
®
Custom materials with a wide range
of performance characteristics
In terms of hardness, only diamond is superior to ceramics. Ceramics are bioinert,
permit ideal surface qualities, exhibit good wettability and are extremely wear
resistant. Depending on the base materials and the processing technology, ceramic
materials can be made with additional unique properties. The BIOLOX® family
offers the materials to meet your future challenges.
The strengths of ceramic in comparison to conventional implant materials
From a surgeon‘s point of view
CERAMIC
METAL
POLYMERS
Trend
Biocompatibility
Infections
Allergies
From a material expert‘s point of view
Hardness
Wear resistance
Weight
Deformation resistance
Corrosion resistance
Fracture toughness
beneficial
neutral
less beneficial
We are working on
Infection resistance: New materials
Optimized mechanical properties:
and surfaces which physically counteract
Ceramic materials and components
microbial contamination, such as the
which move significantly beyond the
filling of microcavities with hydrogel.
existing limits for the material and
Direct-to-bone: Ceramic surfaces
permit a tissue-friendly treatment.
which offer a defined level of rough­
New ways forward: In continuous
ness to permit and promote direct
dialog with physicians, implant manu­
bone ingrowth.
facturers and material scientists, we
Coating: Ceramic-on-metal, metal-on-
are considering solutions which were
ceramic, different combinations of
previously inconceivable and improbable.
ceramics – according to requirement.
We make innovation possible.
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FOUR DECADES OF CERAMIC MEDICAL DEVICES
Certified production, quality assurance and
clinical evaluation
Testing
laboratory
Production
Medical
Product
Know-how
Clinical
studies
Packaging
Quality
management
Approval
In the field of medical devices, people’s lives and health can depend on
the consistent quality of the products. The reliability of our processes
is an essential part of our quality system and it is confirmed by regular
audits performed by our customers and health authorities around the
world. Our four decades of experience in the development, evaluation
and approval of ceramic medical products is a unique expertise available
to CeramTec’s customers.
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Production
The development and manufacture of ceramics with high performance capabilities
imposes the highest standards throughout the whole process. This starts from preparing the carefully selected raw materials to make a physically and chemically perfect
ceramic powder.
From the various molding processes (dry pressing, injection molding, extruding and
tape casting) and the green machining of blanks, to thermal processes and surface treatment (grinding, lapping and polishing), CeramTec brings together the full
spectrum of ceramic knowhow. State of the art production facilities are used at all
steps of the production process. They meet the high requirements for medical device
production. Validated processes are the basis for the delivery of outstanding quality.
Quality assurance
Quality management plays a critical role in the production of medical devices. All production, final inspection and packaging processes meet the latest quality assurance
standards and are DIN and ISO certified. Implants are subjected to a one hundred
per cent – in other words piece by piece – final inspection. During this inspection, all
important quality and product characteristics are documented in full.
The quality of materials and products is constantly being assessed in the testing
and analytical laboratory. Each year, the safety of CeramTec products is assessed
and confirmed by the fact that approximately twenty audits are conducted yearly
by CeramTec customers and heath authorities from around the world.
Approval
CeramTec has four decades of experience in the evaluation and approval of medical
products. Our experts are well versed with all the steps and regulatory details required
to obtain approval for our products. This can include anything from laboratory testing
to clinical studies.
BIOLOX® components are approved for clinical use in practically all countries
around the world. CeramTec possesses comprehensive knowhow in obtaining
approval for implants and medical devices in almost all markets worldwide.
Of course, our expertise in this field is also available to our customers in the medical
devices industry. We can assist you with all issues related to product certification,
clinical testing and market authorization.
Medical Engineering Division
Luitpoldstraße 15
91207 Lauf, Germany
Phone:+49 9123 77-530
Fax: +49 9123 77-443
[email protected]
www.ceramtec.com
The information contained in this document was gathered and compiled by medical experts and qualified CeramTec employees to the best of their knowledge.
The greatest care was taken to ensure the accuracy and ease of understanding of the information used and presented. CeramTec does not assume any liability,
however for the up-to-dateness, accuracy, completeness or quality of the information and excludes any liability for tangible or intangible losses that may be
caused by the use of this information. In the event that this document could be construed as an offer at any time, such offer shall not be binding in any event
and shall require subsequent confirmation in writing.
ME120002 · EN · 1000 · 1205 · Loopkomm Infomarketing · Printed in Germany
CeramTec GmbH