PRO-DENSE Core Decompression Procedure Kit - 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. 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. To act only as a temporary support media and is not intended to provide structural support during the healing process. The kit is intended to facilitate a standard core decompression procedure.

Functional description

The PRO-DENSE Core Decmpression Procedure Kit, consisting of bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process.