Indications / Contraindications
INDICATIONS
PRO-DENSE™ resultant paste 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 adults 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.The PRO-DENSE™ paste cured in situprovides 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™ is provided sterile for single use only.
CONTRAINDICATIONS
The PRO-DENSE™ Bone Graft Substitute injectable paste is contraindicated where the device is intended as structural support in load-bearing bone and in articulating surfaces. Conditions representing relative contraindications include:
- Severe vascular or neurological disease
- Uncontrolled diabetes
- Severe degenerative bone disease
- Closed bone void/gap filler
- Pregnancy
- Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol
- Hypercalcemia
- Renal compromised patients
- Patients with a history of or active Pott’s disease
