This page is only intended for products sold and distributed in the US. For ordering the products, please contact our local US distributor, TriMed Inc.
Concerning products and solutions sold in other countries, please visit international website. Please note that the products presented under International website are not FDA Cleared for US commercialization.
Indications for use
Bonalive® Orthopedics granules is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Bonalive® Orthopedics granules is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product contains a bone void filler that resorbs and is replaced with bone during the healing process. When used in the extremities and pelvis, Bonalive® Orthopedics granules is intended to be used alone.
Bonalive® Orthopedics granules should not be applied:
- To replace structures that are subject to strong mechanical stress;
- In patients that have received or are to receive chemo-therapy or radiation therapy at or near the implant site; or
- In patients with known allergy to bioactive glass.
The S53P4 bioactive glass gradually resorbs over time and is replaced by bone. The bioactive glass in the Bonalive® Orthopedics granules is radiodense thus enabling postoperative radiologic evaluation.
Bonalive® Orthopedics granules is available in different granule and unit sizes.
Possible complications are the same as to be expected of autogenous bone grafting procedures and general complications that may arise from anesthesia and/or surgery.
See IFU within the product package for complete information of Bonalive® Orthopedics granules.
Bonalive® Orthopedics granules is a sterile medical device made of S53P4 bioactive glass. This synthetic, osteoconductive material is comprised of SiO2, Na2O, CaO and P2O5. Bioactive glass is characterized by its ability to attach firmly to living tissue. Other properties include its ability to facilitate bone tissue growth, bond chemically with surrounding bone, and promote new bone formation in the implanted area.
Bonalive® Orthopedics granules is only intended to be used by physicians familiar with bone grafting and fixation techniques.
- Bonalive® Orthopedics granules is only intended to be used by physicians familiar with bone grafting and fixation techniques.
- Bonalive® Orthopedics granules does not provide mechanical strength to support load-bearing defects before hard tissue has formed. If a fracture requires load supporting fixation, standard internal or external stabilization techniques must be used to achieve rigid stabilization in all planes.
- Screw purchase or screw stabilization must not be attempted on recent Bonalive® Orthopedics granules implantation sites where sufficient bone growth is not confirmed.
- Bonalive® Orthopedics granules are not intended for use with defects other than those listed in the indications for use statement. Pre-operative and post-operative patient management should follow the same regimen as similar cases utilizing autogenous bone grafting.
- The device has not been clinically tested for use in pregnant women.