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Truly Synthetic Biocompatible Bone Graft Substitute.
 

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.

B-OstIN
means Basic 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.
  • Biocompatible - It first and the foremost requirement for any device to be implanted, because of increased awareness of safety.
  • Osteoconductive - For faster bone integration between host bone and bone graft substitute.
  • Non-Immunogenic - The implant should not be a vector of disease transmission or it should not give any adverse effects after its implantation.
B-OstIN addresses these features:
  • Biocompatible - B-OstIN has been implanted over 500 patients with minimum 12 months of follow up and no adverse effects reported.
  • Osteoconductive - The most osteoconductive material which helps in bone bonding with in three months , fastest of all ceramics constituents.
  • Non-Immunogenic - No cytotoxicity or adverse effects have been reported after the implantation of B-OstIN.

Biocompatibility (Read more)

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.

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.
Biocompatible B-OstIN - Animal/ Clinical Studies
  • Animal Studies - Rabbit Tibia
    Histological sections showing progressive bone formation in rabbit tibia around
    B-OstIN granule at various time periods.




     

  • Clinical Study - Tibia Plateau fracture study

                            The Fracture                                      Immediate Post Operative

                       Follow up 6 months                      Follow up 1year Granule are
    still visible
                     (well healed fracture)                       but bone granule
    boundary is distinct

Osteoconductivity (Read more)

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.

Chemical Composition
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.

Morphology
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.

Osteoconductive 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.

                                               X-Ray Diffraction 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 material.
  • Porosity and Pore Size - The porosity of 60 to 70 percent with pore size ranging between 100-300  m is the most optimum for bone in growth.

                                      Porosity Distribution graph showing tight control                         
     
  • Purity - The trace elements are maintained within limits defined by ASTM-1185-88.
Non-Immunogenic (Read more)
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.

Non-Immunogenic - Test as per ISO 10993 (Biological Evaluation of Medical Devices)
  • Haemolysis test - B-OstIN 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
    B-OstIN after Haemolysis test
     
  • Cytotoxicty test - B-OstIN does not show any cytotoxic effects in contact with L 929 Cell Culture.

    No Cytotoxicty effect on contact with
    B-OstIN
     
  • Subctaneous Implantation test - B-OstIN proved to be successful in prolonged test with soft tissues.
    • 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:
     
                          Spinal Fusion                                     Vertebral Fracture        Bone Void Filler (Bone TB)

      

    Tibia Plateau Fracture           Distal Radius Fracture                    Calcaneus Fracture

Product Presentation

B-OstIN Granules

B-OstIN Rod

B-OstIN Block

 
 
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