Biomedical Engineering Reference
In-Depth Information
The United States Food and Drug Administration (FDA) has
approved several cement formulations for clinical use [22, 202]. Some
examples are given in Table 5.1. The same formulations have also
received a Conformite Europene (CE) mark for certain maxillofacial
indications and for use as a bone-void filler in the specific non-load-
bearing orthopedic indications [137]. The major properties of these
formulations are available in literature [22]. An extended list of the
cement formulations is presented in Table 5.2 [125]. Other lists
of the commercially available injectable bone cements with their
chemical composition (when obtainable) might be found elsewhere
[34, 144, 203, 204], while various types of bone cements and fillers
are listed in still another review [198]. A general appearance of two
randomly chosen commercial calcium orthophosphate cements is
shown in Fig. 5.1. Besides, even more cement formulations are in
experimental stages.
Table 5.1
Some self-setting calcium orthophosphate cement formulations
having the 510(k) clearance from the FDA [20, 137, 202].
The technical data on these cements might be found in
literature [22].
Product
*
Manufacturer
Applications
*
BoneSource
TM**
Striker Howmedica
Osteonics (Rutherford, NJ)
Craniofacial
α-Bone Substitute
Material (α-BSM
®
)
***
Etex Corporation
(Cambridge, MA)
Filling of bone defects
and voids, dental,
craniofacial
Skeletal Repair
Systems (SRS
®
)
Norian Corporation
(Cupertino, CA)
Skeletal distal radius
fractures, craniofacial
*
In Europe, other applications may apply, and the materials may be sold with a
different commercial name.
**
TM
is the original formulation of calcium orthophosphate cement
developed by Brown and Chow.
***
BoneSource
In Europe, it is distributed by Biomet Merck (Zwijndrecht, The Netherlands) as
Biobon
®
[137], while in North America it is marketed by Walter
Lorenz Surgical (Jacksonville, FL) as Embarc
®
[22].
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