Product Description

Iceberg TCP is a porous synthetic ceramic, containing 99,9% tricalcium phosphate, designed for the filling of bone voids or defects. The macroporosity of Iceberg TCP allows an excellent osteointegration, as well as a total vascularization of the implant due to the interconnected porosity. Iceberg TCP is highly bioactive and undergoes total or partial resorption. It is replaced by new bone during healing process. The calcium phosphate ceramic is manufacture in the form of blocks, granules, cylinders and wedges, having the possibility of custom made devices.

Key Factors to enhance osteointegration:

• Porosity of blocks, cylinders, wedges: 80%
• Porosity of granules: 90%
• Pore size 300 - 500 microns
• Interconnected porosity creating open channels
• Material that provides osteoestimulation
• 100% reabsorbed – replaced by new bone tissue

Indication

Iceberg TCP is intended to be used as a bone void filler or augmentation material for bone defects that are not intrinsic to the stability of the bony structure. When placed in the implantation site, cellular adhesion starts occurring on the surface of the pore, and continues to proliferate though the interconnected pores producing an extracellular matrix until bone mineralization occurs.

Fine granules (0.1 - 0.5 mm), medium granules (0.5 - 1 mm) and coarse bulky granules (1 - 2 mm), covering all applications in maxilla-facial areas, from small and medium periodontal, cyst defects, alveolar filling or augmentation to sinus floor elevation. For larger cysts, reconstruction of tumor voids, or large reconstruction sites, larger granules (3 – 4 mm), blocks or cylinders are recommended.

Advantages

• Safety 

100% Synthetic. No human nor animal origin.

• Osteoconductive

Open porosity highly interconnected with a high mechanical resistance.

• Resorbable

Iceberg TCP is replaced by new vital bone within 1 – 6 months. In some cases the resorption time can be larger depending on the size of the defect and the quantity of synthetic bone used. No significant variations of bone density since the bone defect is replaced by natural bone.

• Radiopaque

Allows the perfect monitorization of osteointegration.

• Easy handling

The unique 3D dimensional structure with a high interconnected porosity enhances fluid absorption and particle agglomeration facilitating the application of the product on the implant´s site.

• Geometries     

Large spectrum of shapes and quantities for the standard fitting.

• Custom made Implants

Manufactured according to the patient’s CAT Scan or MRI data for the perfect reconstruction.

Instructions for use

1. Iceberg TCP can be used in the form of granules, blocks, cylinders and wedges.
   
2. Iceberg TCP in the form of granules helps to fill empty irregular spaces.
3. Impregnate Iceberg TCP with patient's blood or autologous bone marrow.
4. Iceberg TCP should be put in contact with cancellous tissue. The bone surface must be freshened and slightly bleeding.
5. The filling must be complete with slight impaction.
6. The wound closure must be complete and airtight.
7. The combination of Iceberg TCP with any medical substance during implantation is carried out under the Surgeon's responsability.