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CEMENTEK

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 CE Certificate

 510(k)


The best bone substitute


Phosphocalcic hydroxyapatite Ca10(PO4)2(OH)2 is the closest synthetic material to bone in terms of its composition and structure.

CEMENTEK®  / CEMENTEK®  LV is a non stoechiometric HYDROXYAPATITE prepared from the reaction between the acid and base calcium phosphates in the presence of an aqueous solution. 

The CEMENTEK® products are obtained after mixing of liquid and solid phases. It's observed a setting phase then a hardening phase.
The several physico chemical reactions are :
 
                                   Setting phenomenon CEMENTEK® / CEMENTEK® LV
                                   Brushite (DCPD) Formation

                                    - Ca4(PO4)2O + 2H3PO4 + 7H2O------------------- 4 CaHPO4, 2H2O
                                    - Ca3(PO4)2 + H3PO4 + 6H2O---------------------3 CaHPO4, 2H2O






               Platelets ofBrushite

                                   Hardening phenomenon CEMENTEK®  / CEMENTEK® LV in 2 steps
                                   Phase 1 :
                                   Octocalcium phosphate (OCP) formation 
                                   - Ca4(PO4)2O + 4CaHPO4, 2H2O----------------------Ca8(HPO4)2(PO4)4, 5H2O

        


        

               Octocalcium phosphate : Roses sand structure

                                   Phase 2 : 
                                   Hydroxyapatite (HAP) Formation
                                   - Ca8(HPO4)2(PO4)4, 5H2O------Hydrolysis------Ca10(PO4)6(OH)2
                                   - Ca4(PO4)2O + 2 Ca3(PO4)2 + H2O-------------Ca10(PO4)6(OH)2






              Hydroxyapatite : Needles of HAP







CEMENTEK® presentation


  
  
   Malleable : It is malleable for about 15 minutes and hardens in situ.
   Synthetic : It contains no animal or human phase.
   Biocompatible : No toxicity or rejection phenomena have been observed.
   Osteointégrable : Recognised by the bone cells; it integrates perfectly with the tissues.
   Bioresorbable : It disappears after biodegradation leaving space for newly formed bone.

            




   CEMENTEK®LV (or low viscosity) allows an application of the product by percutaneous way.
   CEMENTEK®LV rheology allows an injection trough a trocard of gauge 10 or 11.




CEMENTEK®is supplied sterile, ready-to-use in an operating block. 

- Liquid : vial                                                                               
- Powder : vial                                                                             



Wrist percutaneous Cementoplasty





CEMENTEK® / CEMENTEK®LV Composition




CEMENTEK


PowderLiquid
Tricalcium and tetracalcium phosphate87%H3PO413,8%
NaGP13%Ca(OH)23.4%
  Water ppi QSP82,8%


CEMENTEK LV


PowderLiquid
Tricalcium and tetracalcium phosphate87%H3PO413,8%
NaGP12%Ca(OH)23.4%
Polydimethylsiloxan1%Water ppi QSP82,8%




CEMENTEK® products references

DesignationVolumeReference
CEMENTEK® 208 cm3T815020
CEMENTEK® 4016 cm3T815040
CEMENTEK® LV16 cm3T8150LV


      
      Note :  

      The use of Mini-malax® mixing system improuve the mixture of CEMENTEK® products. 
      The syringe CEMENTEK LV injector® is recommended for the injection of CEMENTEK®LV.


DesignationReference
Mini-Malax®T068102
CEMENTEK LV Injector®T068101


 Bibliography...
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