B-OstIN is synthetic
bone graft substitute, which is prepared by wet chemical
processing. The best chemical available are used in
manufacturing of phase pure synthetic
B-OstIN (HAP). The
manufacturing process conforms to ASTM standards.
OsteoINtegration and is
providing that matters in bone grafting.
What matters most in bone grafting?
The most important features that a bone graft substitute
must possess to offer successful bone integration with
the host bone are as mentioned below.
B-OstIN addresses these features:
- It first and the foremost requirement for any
device to be implanted, because of increased
awareness of safety.
- For faster bone integration between host
bone and bone graft substitute.
- The implant should not be a vector of
disease transmission or it should not give any
adverse effects after its implantation.
been implanted over 500 patients with minimum 12
months of follow –up and no adverse effects
- The most osteoconductive material which
helps in bone bonding with in three months ,
fastest of all ceramics constituents.
No cytotoxicity or adverse effects have been
reported after the implantation of
The biocompatibility of a long-term implantable medical implant refers to the ability of the device to perform its intended function, with the desired degree of incorporation in the host, without eliciting any undesirable local or systemic effects in that host.
- Animal/ Clinical Studies
The increase in awareness of the safety of medical devices has taken an international character, in large part because of the convergence of FDA regulations and International Organization for Standardization (ISO) standards. As international requirements for the biological evaluation of materials continue to be developed and issued, the use of the chemical characterization of materials to establish biocompatibility has become essential.
The ability of a implant to act as scaffolding that supports new bone formation and the bone growth.
Factors that influence osteoconductive nature of a bone graft are its chemical composition and morphology.
The Ca/p ratio present in hydorxyapatite of natural bone is 1.67 . Any ceramic material having Ca/ P nearer to or similar 1.67 will be good osteoconductive.
Porosity and interconnectivity among macro and micro pores also influence the osteoconductive feature of a bone graft substitute. Bone is living tissue that grows into implant incorporating it into the body. More porous the implant more space is available for bone to grow in and secure the implant.But , Porosity also influences the mechanical strength of the implant . Highly porous the material , lesser the mechanical strength .Therefore we need to have an implant with optimum porosity, that allows good mechanical strength.
B-OstIN- Chemical Composition and porosity
Chemical Composition - Chemically phase pure Hydroxyapatite prepared by wet chemical
processing. The strict control on the process
ensures Phase Purity and crystallinity as
depicted by X-Ray Diffraction Analysis.
with Single Peak
Morphology - Te Ca/ P ratio is 1.67 in B-OstIN
is exactly similar to mineral content of human
bone. It makes B-OstiN the most osteoconductive
Porosity and Pore Size - The porosity of
60 to 70 percent with pore size ranging between
100-300 µm is the most optimum for bone in
Distribution graph showing tight control
Purity - The trace elements are
maintained within limits defined by
Any implant to be placed inside the human body, it should not be vector of disease transmission. Moreover its implantation shall not depend on suppression of immune system of the recipient . Suppression of immune system will make the recipient body susceptible to various infections. Therefore, non-immunogenic feature of an implant influences its usage.
A product is said to be non-immunogenic, if body does not produces an anti-body response against the implanted material. Once the metal implant has been incorporated in the host environment it should not give any systemic or local adverse effect.
To establish the Non- Immunogenic nature of the in-vitro and in-vivo tests should be performed. These test includes cytotoxicity, subcutaneous implantation and hemolysis test. The results of these in-vitro and in- vivo studies should be documented and published.
- Test as per ISO 10993
Evaluation of Medical Devices)
Haemolysis test -
does not result in lysis of Red Blood Cells.
The Haemolysis of the finished products is less
than 2% where as the ISO 10993 Standard defines
maximum limit as 5%.
Intact RBC over
after Haemolysis test
Cytotoxicty test -
does not show any cytotoxic effects in contact
with L 929 Cell Culture.
No Cytotoxicty effect on contact with
Subctaneous Implantation test -
proved to be successful in prolonged test with
- Implants surrounded by cellular infiltrate
which was predominantly fibroblastic.
- Macrophages , lymphocytes and plasma cells
also present at the site.
- No tissue necrosis and acute inflammation.
Indications for use: