PRO-DENSE Injectable Bone Graft Substitute - Bone matrix implant, artificial

Intended purpose

For use as a bone graft substitute to be injected or digitally packed into open bone voids/gaps that are not intrinsic to the stability of bony structure of the skeletal system (i.e., the extremities, spine, and pelvis) to cure in-situ. These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. The paste cured in-situ provides an open void/gap filler that can augment provisional hardware (e.g K-Wires) to help support the bone fragments during the surgical procedure. The cured paste acts only as a temporary support media and is not intended to provide structural support during the healing process.

Functional description

Calcium salt cement formulation consisting of a powder component and an aqueous mixing solution. When the two components are mixed according to the directions, an injectable paste is formed which is injected into the implant site to cure in situ. Consists of a kit containing implant material calcium sulphate/calcium phosphate, an instrument kit consisting of syringe/s and needles, implant kit consisting of 1 powder container, 1 vial of mixing solution, 1 mixer and accessories.