Bone Repair Technology
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Actifuse Bone Graft Substitute Indications and Important Risk Information
Orthopedic Indication for ACTIFUSE Bone Graft Substitute
Actifuse Bone Graft substitute is a bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. Actifuse Bone Graft substitute is indicated to be packed gently into bony voids or gaps of the skeletal system, i.e. extremities, pelvis and spine including use in posterolateral spinal fusion procedures with appropriate stabilizing hardware. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Important Risk Information for ACTIFUSE Bone Graft Substitute
Actifuse Bone Graft substitute is contraindicated where the device is intended as structural/load-bearing support in the skeletal system. Actifuse Bone Graft substitute has not been cleared for use in vertebroplasty.
Attempts should not be made to modify the size of the granules or to change their shape. It is important to maximize contact between existing bone and the implant to ensure proper bone regeneration.
The effect of mixing ACTIFUSE Bone Graft Substitute with substances other than sterile saline/water, autologous blood or bone marrow aspirate is unknown.
Rx Only. For safe and proper use please refer to full device Instructions for Use for Contraindications, Warnings, and Precautions.
Actifuse Full Prescribing Information:
Altapore Bioactive Bone Graft Substitute Indications and Important Risk Information
ALTAPORE Bioactive Bone Graft Shape Indications
Altapore Bioactive Bone Graft Shape is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine and pelvis). Altapore Bioactive Bone Graft Shape can be used by itself, or with autograft as a bone graft extender in posterolateral spinal fusion procedures.
These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure.
Altapore Bioactive Bone Graft Shape resorbs and is replaced with bone during the healing process.
Important Risk Information
Altapore Bioactive Bone Graft is contraindicated where the device is intended as structural/load-bearing support in the skeletal system. Altapore Bioactive Bone Graft has not been cleared for use in vertebroplasty. Attempts should not be made to modify the size of the granules or to change their shape. It is important to maximize contact between existing bone and the implant to ensure proper bone regeneration.
The effect of mixing Altapore Bioactive Bone Graft with substances other than bone marrow aspirate or autologous bone is unknown.
Disclaimers
Rx Only. For safe and proper use of product mentioned herein, please refer to the Instructions for Use or Operator Manual.
Actifuse and Altapore are trademarks of Baxter International Inc. or its subsidiaries.
Any other trademarks, product names or brand images are the property of their respective owners.