Bone Substitute Materials - Biomet

Bone Substitute Materials
Overview

Content
Introduction 3
Overview 4
Endobon 6
Calcium Phosphate 8
Calcibon Paste 10
Calcibon Granules 12
Ordering Information 14
References 16
What can patients and surgeons expect from us? Reliable products,
and expertise, which ensures secure application. Moreover, developments
needed in the future.
Biomet is one of the leading orthopaedic companies worldwide. We
develop and produce products for orthopaedic and trauma surgery.
Our predominant competence enables us to accompany our clients
continuously in clinical surgeries.
This vicinity has an impact: We take impulses in, and our own Research
and Development Department is a direct contact partner for new ideas.
Here we connect the clinically documented quality of our implants with
the future orientated possibilities of bioactive materials. Through this we
become an innovation force and are able to face the continuous developments
in our markets more flexibly.
The results are products and performances, that aid the surgeons’
community, to support the healing process of their patients in a
medically optimal, scientifically proven, and cost-effective manner.
2
Legal notice
This material is intended for educational purposes only. Any medical information included herein
is for information purposes and shall not be used in any way as substitute for professional advice
provided by a physician or other health care provider.

Bone Substitute Materials from
Biomet
Time-tested Products
Autologous graft, bone bank or bone substitute material?
The first criterion when treating a bone defect is always
a rapid recovery process, without as few complications
for the patient as possible. More over economical and
technical aspects are essential. The treatment with
bone substitutes proves to be well suited for the
treatment of bone defects with respect to availability,
duration of surgery and incurred costs, linked with
excellent compatibility and documented treatment
achievements.
Quality and Unlimited Quantity
Biomet developed a portfolio of bone substitute materials
(based on mainly hydroxyapatite calcium phosphates). Unlike
autologous material, they have the advantage to have a
rapid availability in constant quality and unlimited quantity.
Furthermore, the application of bone substitute materials
avoids a second surgery for harvesting autologous material:
The duration of the surgery and the anesthesia are reduced
and patients are not faced with possible complications and
pain at the donor site.
Bone substitute materials have advantages in comparison
to bone bank materials: There are no logistics issues in
providing the materials for surgery and they are available in
adequate quantity.
A Solution for Each Indication
Not all bone substitute materials are the same: For each
separate indication, suitable bone substitute materials
were thoroughly researched and developed. Particularly
the utilisation of different substances with specific
characteristics and functionalities supports the healing
process in the long run. Biomet's bone substitute materials
have proven to be of high quality for a number of
years already. Their excellent biocompatibility and their
clinical success are documented extensively. Praxisorientated
trainings and consulting services aid to support
surgeons and their personnel in order to ensure consistent
successful application.
3

Overview Bone Substitute Materials:
A Solution for Each Indication
A precondition for successful clinical use of bone substitutes
are the exact indication and the correct application. They
are suitable for non-infected, metaphyseal, cancellous bone
defects. Bone substitutes should only be implanted into a
vital bony bed. When utilizing bone substitute materials,
it is always vital to carry out a correct reposition and an
adequate osteosynthesis.
Product Endobon Calcibon
Blocks, Cylinder,
Granules
Paste
(liquid & powder)
Basic Material Hydroxyapatite (ceramic) Calciumdeficient hydroxyapatite
Material Properties
Biological
Stable osseous integration
Ready-to-use
Augmentable
Porous
Synthetic
Stable osseous integration
Characteristics Osteoconductive Osteoconductive
Biodegradable
Indications
1. Tibia plateau fractures
2. Osteotomies
1. Distal radius fractures
2. Calcanus fractures
3. Tibia plateau fractures
4

Calcibon Granules
Granules
Calciumdeficient hydroxyapatite
Synthetic
Stable osseous integration
Ready-to-use
Augmentable
Porous
Osteoconductive
Biodegradable
1. Mixing with spongiosa
2. Large bone defects, e.g. hip revision
5

Endobon
Primary stable
Osteoconductive
Interconnecting pore system
Augmentable
Endobon is a natural hydroxyapatite ceramic (HA ceramic),
which is particularly suitable as a bone graft substitute. It is
of biological origin and osteoconductive. The newly formed
bone can grow directly onto the ceramic surface and into
the implant. The interconnecting pore system of Endobon
allows the new bone to grow through the whole implant.
Indications
Endobon is an excellent bone substitute material for
impression fractures close to the joint, like tibia and
radius fractures, for fractures of the calcaneus and for
osteotomies.
Material Properties
Endobon is a primary stable hydroxyapatite ceramic. The
inner structure with its interconnecting system of macro
and micro pores with pore sizes of 100 to 1,500 μm
allows the newly formed bone to grow through the whole
implant. This finally leads to a stable osseous integration of
the Endobon implant.
Endobon has a porosity of 45-85 Vol.% and a density
of 0.4 to 1.6 g/cm 3 resembling the values of natural bone.
Quality and Production
Endobon is manufactured in a two-stage high-temperature
process:
• 1. Pyrolysis above 900°C
• 2. Sintering above 1,200°C
This leads to a complete combustion and ablation of all
bacteria, viruses, and prions from the original material.
Endobon has been successfully used in clinical applications
for more than 15 years.
Usage
Endobon is available in the form of blocks, cylinders, or
granules of different sizes. The latter are especially suited
for augmentation of autologous bone chips.
All forms are easily and rapidly usable during surgery.
The blocks and cylinders are especially suitable for
fractures below load bearing joints, e.g. tibia plateau
fractures. The granules should be used for filling irregularly
formed defects.
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6 Weeks Post-operatively
6 weeks after the implantation of Endobon, integration of
the implant with the surrounding vital bony bed can be seen
on the microscopic analysis.
3 Months Post-operatively
After 3 months, the microscopic analysis shows a nearly
complete osseous integration of the implant.
6 Months Post-operatively
After 6 months, the histological slide shows direct contact
of the newly formed bone (1) and the ceramic surface (2).
2
1
7

Calcium Phosphate – The Calcibon Family
Synthetic
Primary stable
Osteoconductive
Biodegradable
Calcibon is a synthetic, biodegradable bone substitute
material. It belongs to the family of calcium phosphates,
a group of osteoconductive bone substitutes. The cured
Calcibon material is a micro-crystalline, calciumdeficient
hydroxyapatite. The chemical composition and the crystalline
structure of the cured material mimic the mineral part
of natural bone.
Material Properties
Calcibon powder is synthesized from calcium and phosphate
salts. Its different components are Tri-calcium-phosphate,
calcium-hydrogen-phosphate and calcium carbonate.
The Biodegradability
Calcibon has the potential to be biodegraded by the
surrounding vital bony bed through remodelling. Calcibon is
thereby broken down by osteoclasts and the new bone is
reconstructed by osteoblasts.
The remodelling process depends on the individual and
the environment where Calcibon is implanted. A vital bony
bed, close contact with the surrounding bone, and a functional
stimulation improve the rate of the remodelling.
8

Calcibon – Two Products: Paste or Granules
The synthetic calcium-phosphate material Calcibon is
available in two different forms: as a paste, mixed from a
liquid and a powder component, or ready-to-use as
granules.
Despite identical origins the two products, Calcibon and
Calcibon Granules differ in their properties regarding
further processing. Both products are introduced in more
detail on the following pages.
• Osteoclasts recognize
bone mineral like surface
• Osteoclasts start
degradation
Mechanical stimulation
Differentiating factors
Mesenchymal stem cells
Pre-osteoblasts
New bone matrix
• Differentiation of
mesenchymal stem cells
• Activation of
pre-osteoblasts
• Osteoclasts release
differentiating factors
and thereby induce
differentiation
and activation
of pre-osteoblasts
Osteoblasts
• Osteoblasts synthesis
and deposit new bone
matrix with subsequent
mineralization
9

Calcibon Paste
High compressive strength
Good clinical results
Easy handling
Hardens in aqueous environment
Calcibon consists of two components: Calcibon liquid
and Calcibon powder. Mixing these two components
results in a smooth and malleable paste ideal for filling bone
defects. The paste hardens at body temperature in-situ and
reaches a very high compressive strength.
Processing
The Calcibon paste is mixed directly before application.
Calcibon liquid is an aqueous di-sodium-hydrogen-phosphate
solution, which initiates the curing process within the
paste.
The processing cycle of Calcibon has been optimized in
consideration of the Operating Room environment:
• Short mixing time 1 minute
• Sufficient application time 4 minutes
• Acceptable final setting time 5 minutes
Overall required time
10 minutes
The Compressive Strength
One of the outstanding properties of Calcibon is its
extremely high compressive strength. In-vitro testing shows
that after 6 hours, the cured final material shows a compressive
strength of approximately 15 MPa, already in the
range of the strength of cancellous bone (10-20 MPa). This
compressive strength continues to increase over time and
results in a final strength of up to 45 MPa after 3 days.
Thus, the compressive strength is in the area of cortical
bone (25-100 MPa).
Compressive strength versus time
After 6 hours the compressive strength of Calcibon is comparable to
that of cancellous bone. After 3 days the final compressive strength
of up to 45 MPa is reached.
10
Compressive strength (MPa)
60
45 MPa = 3 days
40
20
15 MPa = 6 hours
0 50 100
Time (h)

Indications
Calcibon is indicated for refilling of noninfected, metaphyseal,
cancellous bone defects caused either by
trauma, benign tumour, surgery, or congenital. Calcibon
may also be used to refill cavities created in connection with
kyphoplasty, if classified as fracture type A1 (according to
Magerl classification).
Osteoblasts
Osteocyte
The most common indications for the clinical use of
Calcibon are distal radius fractures, tibia plateau fractures,
and calcaneus fractures.
Usage
The cohesion time of Calcibon is extremely short. Already
after mixing, the binding forces inside the paste are high
enough to ensure the form stability of the material, even in
an aqueous environment.
Calcibon
2 weeks post-operatively
Detailed picture of the bone formation at the contact site Calcibon implant-bone.
The Calcibon surface is covered with an osteoid-layer (*).
Bone
Even though Calcibon should be implanted into a dry and
blood-free environment, the short cohesion time allows an
implantation into a wet bony bed, where the material will
keep its form and harden adequately.
Calcibon
16 weeks post-operatively
Parts of the Calcibon implant material have been biodegraded followed
by bone in-growth. Remodelling activity at the interface, as characterised
by the presence of remodelling lacunae (RL) and osteoclast-like cells
(black arrows), was still seen.
Calcibon
24 weeks post-operatively
Continued biodegradation of Calcibon and subsequent bone in-growth.
The new bone is mature and cannot be discerned from original trabecular
bone.
11

Calcibon Granules
Refilling of lange bone defects
Porosity supports remodelling process
Augmentation with other material
Utilization in revision surgery
Calcibon Granules are a line extension of the existing
Calcibon product range. Like the paste, the granules are
also manufactured synthetically, are biodegradable and
biocompatible. The main differences: The granules are
ready-to-use, however, due to their porosity the compressive
strength is reduced. In addition they are highly suitable
to be used for augmentation in combination with other
materials.
Material Properties
The production process of Calcibon Granules is at first
glance identical to the one of the Calcibon powder. Nevertheless,
the mixing of the two components already takes
place during production. The granules are hence a completely
hardened material. Due to a special manufacturing
technique porous granules with micro and macro pores are
produced.
The porous Calcibon Granules have macro pores of 150-
550 µm. These allow cells, e.g., osteoclasts and osteoblasts,
to migrate into the granules. The activities of these
cells enable the cellular biodegradation of the Calcibon
Granules and the formation of new autologous bone.
The macro pores are separated from each other by thin
walls, which in turn consist of a micro porous network.
These micro pores allow the cells involved in the remodelling
process to be supplied with nutrients.
12

Indications
Generally, Calcibon Granules are intended for filling and
reconstructing large, non-infected, metaphyseal, cancellous
bone defects. The origin of these defects can vary
greatly; from e.g., trauma, benign tumour, surgery, to
congenital.
Calcibon Granules can be used as filling material for
revision hip surgery, e.g., for the reconstruction of the
acetabulum and to fill the shaft. Moreover, the granules can
be used as filling material for cages in spinal surgery.
Use
Calcibon Granules are ready-to-use. No mixing time has to
be taken into account.
2 ml Calcibon Granules mixed with 1 ml PRP (Platelet-Rich-Plasma of
Biomet Biologics)
Calcibon Granules can be applied directly to the aseptic
bone bed or augmented with other material, such as
bone marrow, bone grafts, blood, and PRP (Platelet-Rich-
Plasma, extracted with the GPS III System).
Scanning electron microscope image of the interconnecting micro pore
system. Magnification x 3,000
13

Ordering Information
Calcibon Synthetic calcium-phosphate
Product Description Quantity Art. Nr.
Calcibon 5 g circa 4 ml paste 30 3005 0001
Calcibon 10 g circa 8 ml paste 30 3010 0001
Calcibon 20 g circa 16 ml paste 30 3020 0001
Calcibon Granules 10 10 ml Granules 30 3210 0001
Calcibon Granules 20 20 ml Granules 30 3220 0001
Calcibon Granules 50 50 ml Granules 30 3250 0001
Endobon Hydroxyapatite
Product Description Size Art. Nr.
Block 5 5.0 x 5.0 x 10.0 mm 30 2037 0001
Block 12.5 12.5 x 12.5 x 10.0 mm 30 2030 0001
Block 20 20 x 20 x 10.0 mm 30 2031 0001
Product Description Size Art. Nr.
Cylinder 9 Ø 8.50 x 20 mm 30 2022 0001
Cylinder 10 Ø 9.55 x 20 mm 30 2023 0001
Cylinder 11 Ø 10.60 x 20 mm 30 2024 0001
Cylinder 12 Ø 11.70 x 20 mm 30 2025 0001
Product Description Granules size Art. Nr.
Granules I 5 ml 1.5 - 2.8 mm 30 2034 0001
Granules II 5 ml 2.8 - 5.6 mm 30 2035 0001
Granules II 10 ml 2.8 - 5.6 mm 30 2069 0001
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Notes
15

References
IW850011
12/2009
Endobon
Calcibon and Calcibon Granules
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European Society of Biomechanics, Dublin, Ireland, 27–30th August
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neuen Calciumphosphat-Zement nach Ballon-Kyphoplastie”.
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Libicher M., Kock H.J., Haag M., Kasperk C.: „Die Wertigkeit
der Ballonkyphoplastie bei der osteoporotischen Wirbelkörperfraktur”.
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This material is intended for the sole use and benefit of physicians. It is not to be
redistributed, duplicated or disclosed without the express written consent of Biomet.
Worldwide distributor
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Gustav-Krone-Str. 2
D-14167 Berlin
Tel.: +49 / 30 / 845 81-0
Fax: +49 / 30 / 845 81-110
www.biomet.de
Responsible manufacturers:
Calcibon, Calcibon Granules
Biomet Deutschland GmbH
Gustav-Krone-Str. 2
D-14167 Berlin
www.biomet.de
0123
Endobon
Biomet France S.A.R.L.
58 Avenue de Lautagne
B.P. 75
F-26903 Valence Cedex
www.biomet.fr 0459