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The JGHI Core Decompression Procedure Kit, consisting of a 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. The bone void filler included in the JGHI Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

The JGHI Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments.

JGH1 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 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 paste provides a bone graft substitute that resorbs and is replaced with bone during the healing process. The JGH1 paste 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. JGH1 is provided sterile for single use only.

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