XeliteMed SuperM-Fix Spinal Bone Cement

FDA-Cleared Indications

• Percutaneous vertebroplasty and kyphoplasty to mechanically stabilize vertebral compression fractures.
• Treatment of painful osteoporotic vertebral compression fractures.
• Treatment of painful vertebral compression fractures caused by metastatic disease or other osteolytic lesions, when included in the device labeling.

Clinical Applications

• Cement augmentation during vertebroplasty for symptomatic vertebral compression fractures.
• Cement augmentation during kyphoplasty for symptomatic vertebral compression fractures.
• Stabilization of vertebral bodies weakened by osteoporosis.
• Stabilization of vertebral bodies affected by metastatic or other osteolytic lesions, when indicated by the approved labeling.

Reported off-label uses

• Cement augmentation of pedicle screws during spinal fixation.
• Cementoplasty of selected nonvertebral bones, such as the acetabulum or long bones.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The cement is mixed and delivered through a needle or cannula under fluoroscopic or computed tomography guidance; timing and viscosity must be managed carefully to reduce leakage.
• The available cement kit sizes, mixing components, delivery accessories and working time should be confirmed in the manufacturer’s instructions for use.
• Do not assume compatibility with a specific balloon catheter, cannula, cement delivery system or spinal implant; compatibility depends on the labeled system and procedure.
• MRI safety depends on the cement and any other implanted devices. PMMA cement is generally considered MR compatible once cured, but the MRI labeling for the complete implanted construct should be checked.
• Contraindications and precautions include active infection, uncorrectable coagulopathy, allergy to cement components, severe cardiopulmonary disease, and vertebral anatomy or fracture patterns that make cement leakage especially hazardous.