Indications & Contraindications

Indications

PRO-DENSE^™ Injectable Regenerative Graft is intended 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 and pelvis) to cure in situ.

These open bone voids may be the result of benign bone cysts and tumors (in adult and pediatric patients ≥ 6 years old), 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.

PRO-DENSE^™ Injectable Regenerative Graft cured in situ provides an open void/gap filler that can augment provisional 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.

PRO-DENSE^™ Injectable Regenerative Graft is provided sterile for single use only.

Adverse Events

Possible adverse effects include but are not limited to:

• Wound complications including hematoma, site drainage, bone fracture, infection, and other complications that are possible with any surgery
• Fracture or extrusion of the bone void filler, with or without particulate debris generation
• Deformity of the bone at the site
• Incomplete, or lack of, osseous ingrowth into bone void, as is possible with any bone void filler
• Transient hypercalcemia
• Potential to pressurize material in a closed void, which could result in fat embolization and/or embolization of the device material into the blood stream