StronBone™

StronBone is CE approved in Europe and its US application for approval is premarket notification (510k) is pending.

StronBone Bone Graft Substitute is a synthetic bioactive ceramic bone graft substitute for the repair of bony defects. Based on in vivo studies StronBone Bone Graft Substitute bioactive ceramic surface transforms to bone mineral (hydroxyapatite) and provides a scaffold for cell growth and proliferation. StronBone Bone Graft Substitute guides the three-dimensional regeneration of bone within the defect site into which it is implanted. The irregular shape and size of the StronBone Bone Graft Substitute granules are designed to provide a multidirectional interconnected trabecular structure in the defect site to support natural bone growth. When StronBone Bone Graft Substitute is placed in direct contact with viable host bone, new bone forms. As StronBone Bone Graft Substitute gradually resorbs bone grows in the space previously occupied by the scaffold.

StronBone does not contain any human or animal tissue products.

Notes:

• In the EU, StronBone Bone Graft Substitute is a medical device which has CE Marking approval.
• In the USA, StronBone Bone Graft Substitute is a medical device product which has not yet been cleared through a 510k for clinical use and is available for Research Use Only.