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Mg OSTEOINJECT™

Mg OSTEOINJECT™ is intended for bony voids or defects of the extremities and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.

Mg OSTEOINJECT™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.

Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.

Mg OSTEOINJECT™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOINJECT™ is resorbed and replaced with bone during the healing process.
Mg OSTEOINJECT™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Mg OSTEOREVIVE™

Mg OSTEOREVIVE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.

Mg OSTEOREVIVE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.

Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.

Mg OSTEOREVIVE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOREVIVE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOREVIVE™ must be used with morselized autograft and/or allograft bone in the posterolateral spine.

When used in intervertebral body fusion procedures Mg OSTEOREVIVE™ must be used with morselized autograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mg OSTEOREVIVE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

Mg OSTEOCRETE™

Mg OSTEOCRETE™ is intended for bony voids or defects of the extremities, posterolateral spine, intervertebral disc space, and pelvis that are not intrinsic to the stability of the bony structure. These osseous defects may be the result of benign bone cysts and tumors (in adults and pediatric patients > 6 years old), may be surgically created osseous defects or osseous defects created by traumatic injury to the bone.

Mg OSTEOCRETE™ can be used as an adjunct to conventional rigid hardware fixation by supporting the bone fragments during the surgical procedure only in the extremities and pelvis.

Once the material has set, it acts as a temporary support medium and is not intended to provide structural support during the healing process.

Mg OSTEOCRETE™ is intended to be placed into bony voids either before or after final fixation.
Mg OSTEOCRETE™ is resorbed and replaced with bone during the healing process.
Mg OSTEOCRETE™ must be used with morselized autograft and/or allograft bone in the posterolateral spine.

When used in intervertebral body fusion procedures Mg OSTEOCRETE™ must be used with morselized autograft and/or allograft bone with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Mg OSTEOCRETE™ is not intended to treat large defects that in the surgeon's opinion would fail to heal spontaneously.

This submission includes three (3) devices with separate trade names bundled into the single 510(k) application. The purpose of this application is to expand the indications to include specific language for use in pediatric patients > 6 years old. The subject devices are a magnesium-based synthetic bone void filler that is moldable, drillable, resorbable, adhesive/cohesive, radiopaque, and osteoconductive. The subject devices consist of a powder component (magnesium-based compound) and a mixing solution (buffered saline). Once the components are mixed intra-operatively prior to implantation, an acid-base reaction occurs to form a cohesive paste. Once the product is placed into the bony void, the paste will adhere to the adjacent bone during the curing process. The devices are provided sterile to the end user for single-use only in various sizes from 3 cc to 15 cc.

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