MIIG X3 Minimally Invasive Injectable Graft - Bone matrix implant, artificial

Intended purpose

To be injected into open bone voids/gaps that are not intrinsic to the stability of bony structure in the skeletal system (i.e., the extremities, spine, and pelvis) and to cure in-situ. The open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The MIIG paste provides a bone void filler that resorbs and is replaced with bone during the healing process. The MIIG paste cured in-situ provides an open void/gap filler that can augment provisonal hardware (e.g., K-Wires) to help support 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

Consists of an implant kit containing 1 vial powder (calcium sulfate) and 1 vial of sterile water; and a mixing and delivery kit containing a syringe & cap, 2 needles, 1 spatula and one vacuum mixing bowl. Total Injection time ~2.5 min, set time ~11 min.