G FILLINBONE

Synthetic bone substitute with antibiotic for prophylactic action.

G-Fillinbone is composed of 70 % Hydroxyapatite and 30 % ß tricalcium phosphate. The composition of the materials complies with the prevailing standards.

It has been specially designed to fill in bone cavities for orthopaedic surgical operations (except contaminated surgery), in particular cases:

  • joint prosthesis,
  • spinal,
  • traumatology on closed fracture,
  • osteotomies,
  • Filling after tumour ablation.

It is strongly recommended when sensitive germs to gentamicin represent a risk.

Characteristics

  • G-Fillinbone bone substitutes are micro-porous and macro-porous. The macro-porosity has an average size of 500 µm and is totally interconnected. The bone substitutes G-Fillinbone have a porosity and optimised surface to allow the rapid bone ingrowth and a good osseointegration.
  • G-Fillinbone comes in bar, parallelepiped, corner, cylinder or granules form.
  • G-Fillinbone bone substitutes contain 150 mg of gentamicin stocked in the porosity of the implant:

Its function is to prevent the patient from infection of the operated wound when infection by gentamicin sensitive germs is a potential risk. All the gentamicin contained in G-Fillinboneis released locally in the first hours after implantation. Releasing duration is less than 48 hours not to generate antibiotic resistant strains.

Fig.1. Local rate (=synovial liquid) and serum rate (=blood) of gentamicin after implantation of G-Fillinbone in the femur of a sheep (average on 5 sheep).

Fig. 2a : Microstructure of G-Fillinbone : the gentamicin is stored in microporosities

Fig. 2b: Microstructure of G-Fillinbone after 48 h of in vitro diffusion. Microporosities are empty.

Presentation

  • Sterile double-packed
  • Expiration date: 18 months after delivered
  • Store at a temperature < 25°C,
  • Use of gentamicin: Precautions and contra-indications consult manufacturer instructions.

TCP FILLINBONE

TCP Fillinbone is a synthetic resorbable bone substitute composed of 100% ß (ß-TCP). It is manufactured in accordance with a system of quality assurance. Its similarity to mineral components of bones makes them perfectly biocompatible.

TCP Fillinbone bone substitutes are designed to fill in bone cavities or to increase bone amount. They can be used as a support for healing :

  • in case of loss of bone tissue (fracture, pseudarthrosis, arthroplasty repair),
  • for vertebral arthrodesis if the bone substitute is not under mechanical stress,
  • for maxillo-facial surgery,
  • for dental surgery: periodontal or apical filling;

implantology (sinus floor or alveolar crest augmentation, filling of osseous defects around implants).

Its synthetic origin prevents risks associated with transmission of pathogens, therefore guarantees a total safety.

TCP Fillinbone comes in the shape of granules: 0.5, 1, 2 or 4 mm micro and macro-porous granules with a porosity ratio close to 70%.

Characteristics

The surface and interconnected porosity of TCP Fillinbone bone substitutes are optimised for bone ingrowth.

TCP Fillinbone bone substitutes are completely resorbable due to their tricalcium phosphate phase, thereby allowing for the replacement of the bone substitute by natural bone.

Presentation

  • Sterile double-packed
  • Stored at a temperature between 10°C to 40°C
  • Single use product, it shouldn’t be resterilised
  • Expiration date: manufacturing date + 5 years