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2. medicine
3. surgery
4. transplants

chronOS Bone Void Filler
®
Beta-Tricalcium Phosphate (b-TCP) bone graft substitute
Osteoconductive
Resorbable
Synthetic
PRODuCT BROCHuRE
chronOS® Bone Void Filler
chronOS® Granules and Preforms are synthetic, porous,
osteoconductive, resorbable calcium phosphate bone
substitutes, which can replace or supplement autogenous
bone. chronOS Bone Graft Substitute eliminates the need
for autologous bone harvesting, thus reducing overall
patient morbidity.
chronOS Granules and Preforms are manufactured in a
cleanroom environment from a biocompatible, radiopaque
material, beta-tricalcium phosphate (b-TCP). This material
contains two of the main mineral constituents of bone,
calcium and phosphorous. chronOS Bone Graft Substitute
has been used clinically in Europe for more than 20 years,
under the name CEROS 82. Replaced with bone in 6-18 months,
chronOS Beta-Tricalcium Phosphate is ideal for many bone
void filler applications.
chronOS Granules in a sinus lift.
Due to its synthetic manufacturing process, chronOS
Beta-Tricalcium Phosphate shows reliable and standardized
biomechanical properties. The compressive strength of
chronOS Beta-Tricalcium Phosphate averages ~5 MPa, and
is similar to that of human cancellous bone.
chronOS Granules in a tooth extraction.
chronOS Granules in a cyst removal.
DePuy Synthes CMF chronOS Bone Void Filler
Indications and Contraindications
Indications
Oral/Maxillofacial
•To fill, augment, or reconstruct periodontal or bony
defects of the oral and maxillofacial region
•Specifically, for the augmentation of deficient maxillary
and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including:
• ridge augmentation
• sinus lifts
• craniofacial augmentation
• filling of defects of endodontic origin
• filling of cystic defects
• filling of extraction sites
• filling of lesions of periodontal origin
• repair of traumatic defects of the alveolar ridge
• fi
lling resection defects in bone tumors, cysts or other
osseous defects and
• s ubstitute for autogenous or allogenic bone grafts
•chronOS Bone Void Filler is intended to be gently packed
or placed into the surgical site and may be combined
with autogenous blood, bone marrow or saline.
chronOS Bone Void Filler resorbs and is replaced with
bone during the healing process
chronOS Preforms in a Le Fort I advancement and a genioplasty.
Craniofacial
•For the repair or filling of craniofacial defects and
craniotomy cuts with a surface area no larger than 25 cm2
•For the restoration or augmentation of bony contours
of the craniofacial skeleton, including the fronto-orbital, malar, and mental areas
• chronOS Bone Void Filler is intended to be gently packed
or placed into the surgical site. chronOS Bone Void Filler
resorbs and is replaced with bone during the healing process.
Contraindications
chronOS Bone Void Filler should not be used in the presence
of active or suspected infection.
For complete contraindications, adverse events and cautions,
please refer to the package insert.
chronOS Bone Void Filler DePuy Synthes CMF 1
Features
Biocompatible
Biocompatibility is defined as a material’s property to be
compatible with a biological system. The biocompatibility
depends primarily on the material’s chemical composition,
its three-dimensional structure, and its surface topography.
Bone is a composite material consisting mainly of calcium
and phosphate, the two main components of chronOS
Beta-Tricalcium Phosphate. Calcium phosphate minerals
have been widely used as bone substitute materials.
chronOS Bone Graft Substitute is made from pure β -TCP
and is absent of any cytotoxic effects.
Histologic verification:
Simultaneous resorption and new bone formation
osteoblast
(dark blue)
osteoid (blue)
chronOS Beta-Tricalcium Phosphate (gray)
new bone (purple)
chronOS Beta-Tricalcium Phosphate meets the requirements
of ASTM standard F1088, “Standard Specification for
Beta-Tricalcium Phosphate for Surgical Implantation.” In
addition, chronOS Beta-Tricalcium Phosphate has passed
tests for biocompatibility.
chronOS Beta-Tricalcium Phosphate at 12 weeks in a
rabbit critical-sized defect model, in the advanced stages
of resorption. The remaining material is interwoven with
osteoid and mineralized bone. Osteoblasts and osteoid
seams are visible.
2 DePuy Synthes CMF chronOS Bone Void Filler
Engineered for Osteoconductivity
Overall porosity
chronOS Beta-Tricalcium Phosphate has a total porosity of
60% for the granules and 70% for the preforms. A high
porosity enhances the osteoconductivity, although a porosity
that is too high weakens the material’s compressive strength.
chronOS Beta-Tricalcium Phosphate benefits from the
highest possible degree of porosity without compromising
the mechanical strength.
Macropores
The macropores of chronOS Beta-Tricalcium Phosphate
are mainly distributed within a range of 100 µm–500 µm
(Figure 1). This offers the optimal environment for
vascularization and bony infiltration (Gazdag, et al. 1995).
In addition, the macropores are interconnected to allow
bone formation throughout the entire implant (Figure 2).
Micropores
chronOS Beta-Tricalcium Phosphate contains micropores,
which are spaces within the material smaller than 10 µm.
The microporosity increases the surface area where new
bone forms and allows circulation of body fluids (Figure 3).
35%
Distribution
30%
25%
20%
15%
10%
>500
400–500
320–400
240–320
160–240
0%
<100–160
5%
<100
Provides scaffold
To facilitate the bone healing process, bone void fillers should
at least be osteoconductive. This is mainly influenced by three
factors: overall porosity, interconnection of macropores, and
presence of micropores. chronOS Beta-Tricalcium Phosphate
has been designed to optimize these features so that it can
closely mimic cancellous bone and provide a scaffold for
bony infiltration. The compressive strength of chronOS
Beta-Tricalcium Phosphate is approximately 5 MPa which is
similar to cancellous bone.
Pore Size (µm)
Figure 1: Distribution of chronOS Beta-Tricalcium Phosphate
macropores.
Pore Size (
Figure 2: chronOS Beta-Tricalcium Phosphate macrostructure.
Figure 3: chronOS Beta-Tricalcium Phosphate microstructure.
chronOS Bone Void Filler DePuy Synthes CMF 3
Features
Feature
Benefit
Osteoconductive
• Provides scaffold for bony ingrowth
• Gives bone cells a path to lay down new host bone
Fully synthetic
• No risk of disease transmission
• Provides ease of mind for patients
Standardized pore sizes
– macropores: 100 µm–500 µm
– micropores: <10 µm
• Optimal environment for vascularization and bony infiltration
• Increases surface area where new bone forms and allows
for circulation of fluids throughout the implant
• Promotes bone formation throughout the entire implant,
not just at the periphery
Resorbs in 6–18 months
• Resorption rate is similar to the regeneration of new bone
Radiopaque
• Enables visualization of implant position
Can be mixed with blood and bone marrow aspirate (BMA)
• Increased biological activity at the defect site
Ready to use off-the-shelf
• Avoids morbidity and risk of complications from second
surgical site resulting in less pain for the patient
• Sufficient quantity of bone graft substitute
• Shortens OR time
60–70% porous
• Provides optimal structure for bony ingrowth without loss
of stability (~5 MPa compressive strength)
4 DePuy Synthes CMF chronOS Bone Void Filler
chronOS PREFORMS (BlOCKS, WEDGES
anD GRanulES)
chronOS Preforms Blocks
chronOS b-Tricalcium Phosphate Blocks, sterile
Dimensions
710.042.98S
5 mm x 5 mm x 10 mm
710.047.98S
20 mm x 20 mm x 10 mm
chronOS Preforms Wedge, rectangular
chronOS b-Tricalcium Phosphate Wedge, rectangular, sterile
710.050.98S
angle
Dimensions
10°
6.5 mm x 25 mm x 20 mm
chronOS Preforms Wedge, semi-circular
chronOS b-Tricalcium Phosphate Wedge, semi-circular, sterile
710.057.98S
angle
Dimensions
7°
7 mm x 25 mm x 35 mm
Extra Small
chronOS b-Tricalcium Phosphate Granules, sterile
710.000.98S
Granule Size
Volume
0.5 mm – 0.7 mm
0.5 cc
Small
chronOS b-Tricalcium Phosphate Granules, sterile
Granule Size Volume
710.001.98S
0.7 mm – 1.4 mm
0.5 cc
710.002.98S
0.7 mm – 1.4 mm
1.0 cc
710.003.98S
0.7 mm – 1.4 mm
2.5 cc
Medium
chronOS b-Tricalcium Phosphate Granules, sterile
Granule Size
Volume
710.011.98S
1.4 mm – 2.8 mm
2.5 cc
710.014.98S
1.4 mm – 2.8 mm
5.0 cc
chronOS Bone Void Filler
DePuy Synthes CMF
5
Some devices listed in this Brochure may not have been licensed in accordance with Canadian Law and may not be for sale in Canada.
Please contact your Sales Consultant for items approved for sale in Canada.
Limited Warranty and Disclaimer: DePuy Synthes CMF products are sold with a limited warranty to the original purchaser against defects in
workmanship and materials. Any other express or implied warranties, including warranties of merchantability or fitness, are hereby disclaimed.
WARNING: In the USA, this product has labeling limitations. See package insert for complete information.
Rx only
Not all products are currently available in all markets.
Manufactured by (United States):
Synthes USA Products, LLC
1302 Wrights Lane East
West Chester, PA 19380
Telephone: (610) 719-5000
To order: (800) 523-0322
Fax: (610) 251-9056
www.depuysynthes.com
© DePuy Synthes Companies 2014. All rights reserved.
DSUS/MOC/0914/0102 11/14
Legal Manufacturer (Canada):
Synthes (Canada) Ltd.
2566 Meadowpine Boulevard
Mississauga, Ontario L5N 6P9
Telephone: (905) 567-0440
To order: (800) 668-1119
Fax: (905) 567-3185