Injectable Synthetic Bone Substitute

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1 Injectable Synthetic Bone Substitute

2 JectOS JectOS is an injectable synthetic calcium phosphate bone substitute. JectOS is easy to prepare and well-suited for surgical use thanks to a relatively long workable time (3 to 7 minutes). Because JectOS is biocompatible, bioresorbable and osseoconductive, its osseointegration in human bone is excellent. JectOS is delivered in a box containing: - a vial of powder - a vial of liquid - accessories for mixing (bowl and spatula) - a syringe for injecting the product - CE a cannula Indications JectOS is indicated for the filling of bone defects. Chemical Composition Mixing the powder and liquid produces a solid compound blend of DCPD and Beta TCP. The reaction is moderately exothermic, producing a transient increase in temperature (45 C). On completion of the chemical reaction, the final product is composed of two types of calcium phosphate: - DCPD (dihydrated dicalcium phosphate) 55% - TCP (tricalcium phosphate) 45%. Physical Properties - Setting time: 9 to 11 minutes (including 3 to 7 minutes workable time) - Reaction temperature: 45 C - Compressive strength: > 20 MPa Bioresorption Once JectOS is implanted in a bone defect, in close contact with a patient s bone, it will be partially resorbed over time while being simultaneously replaced with newly-formed bone. As a result, and thanks to excellent bioresorption and osseoconductivity properties, JectOS osseointegration is particularly efficient. JectOS Features and Benefits - Synthetic: no risk of cross-contamination. - Biocompatible, bioresorbable, bioconductive: excellent osseointegration to patient s bone. - Radio-opaque: facilitating the observation of product diffusion during injection. - Injectable: minimally invasive surgery. - Easy to use with a 3 to 7 minute workable time; preparation is trouble-free. - Injectable as a paste so that the bone defect can be filled completely. - Sterile on delivery (radiation sterilization). - Low exothermic chemical reaction (45 C).

3 JectOS Each Box contains In a sterile double blister 1. Bowl 2. Spatula 3. Vial of powder 4. Vial of liquid 5. Cannula 6. Syringe (in separate blister)

4 PREPARATION STANDARD TECHNIQUE Preparation of injectable bone substitute in the bowl. PREPARATION SIMPLIFIED TECHNIQUE Preparation of the injectable bone substitute in the vial Connect cannula to syringe. Open vial containing the liquid. Aspirate all the liquid. Connect cannula to syringe. Open the vial containing the liquid. Aspirate all the liquid Inject liquid into the bowl. Add all the powder. Open the vial containing the powder. Inject the liquid into the vial. Close the vial Mix briskly for 30 s. Aspirate the mix immediately and force the air out of the cannula. Shake energetically for 30 s. Open the vial. Aspirate the contents of the vial immediately and force air out of the cannula. Do not implant JectOS before it reaches the consistency of toothpaste Check on whether the mix is hard enough by ejecting a drop every 30 s. The mixture is beginning to set. The mixture is ready for implantation.

5 CLINICAL CASE Filling of distal radius Male, 64 years Laurent OBERT, MD, Besançon (France) Filling of distal radius after harvesting cancellous material for use as a graft in thumb reconstruction. Post-op aspect. At 3 months. At 12 months.

6 CLINICAL CASE Chondroma, 3 rd metacarpal Female, 61 years Dominant side: right ; injured side: left Philippe LIVERNEAUX, Strasbourg (France) 36 month clinical follow-up Pain evaluation (VAS): 0 Q-DASH score: Pre-op. Post-op.

7 REFERENCES Ref. Quantity Box J406C05 J406C10 5 cc 10 cc Box of 1 - Sterile Box of 1 - Sterile MADE BY 18, CHEMIN DE LA VIOLETTE L UNION - FRANCE Tél. +33 (0) Fax +33 (0) contact@kasios.com Specializing in bone substitutes Design : C. Boulard & e-monceaux / Photos : e-monceaux / réf. 786 éd.03 - KASIOS - octobre 2015 DISTRIBUTED BY

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