PHOENIX bone allografts are manufactured from femoral heads collected in France by trained orthopedist surgeons on living donors ONLY (during hip arthroplasty surgery).
Prior selection to donation is of primary importance. Donor patients can be therefore even more strictly and thoroughly screened.
Clinical selection/direct questioning of donors is performed directly by orthopedist surgeons in a face to face interview prior to the surgery. Surgeons also perform femoral head in-situ selection.
A blood sample is taken during the removal of the femoral head for the regulatory testing of any transmissible diseases. Serological analyzes are performed by an independent testing laboratory.
The collection is organized through flexible and efficient logistics in accordance with the Good Manufacturing Practices (GMP) for Tissues issued by the Biomedicine Agency (former French Transplant Establishment ) and in compliance with the Bioethics law.
The selection is then made based on clinical and biological criteria based on the rules of safety.
Only the material compliant with all defined criteria are kept for further treatment.
Today, more than 150 French hospitals are registered TBF partners for femoral heads collection.
Traceability of the tissue is ensured by a unique graft identification number assigned during the collection throughout the graft implantation.
TBF stores the traceability information records for 40 years.
PHOENIX bone grafts are characterized by their safety, ease of storage and use, and their proven and published clinical efficacy.