You currently suffer from a bone defect that requires a surgical treatment. Bony voids can be surgically created or result from a traumatic injury. The aim of bone grafting surgery is to restore the bone volume, in its shape, width and height.
To that goal, the surgeon will use a bone substitute which is a synthetic product used to fill the defect and to facilitate the bone healing /reconstruction. The Synthetic Bone Substitute is intended for use to reconstruct bony voids or bone gaps of the skeletal system (e.g. extremities, spine and pelvis).
The Synthetic Bone Substitute can be used in adults excluding pregnant women and has not been tested in pediatric population.
The Synthetic Bone Substitute is intended for use by physician familiar with bone void filling and rigid fixation techniques. The Synthetic Bone Substitute is to be handled or implanted by trained qualified physicians having read this instruction for use. The implantation of the device on the patient must be evaluated and confirmed by the physician before surgery, considering the potential contraindications provided from the manufacturer.