Osteoset Dbm Pellets

FDA-Cleared Indications

• Filling bone voids or defects that are not intrinsic to the stability of the bony structure.
• Use as a bone-graft material in orthopedic and reconstructive procedures where the defect does not require structural support.

Clinical Applications

• Filling contained bone defects during orthopedic surgery.
• Filling bone voids after removal of nonviable or abnormal bone.
• Use in reconstructive procedures where new bone growth is desired but the graft is not needed to provide structural stability.

Reported off-label uses

• Use in selected spinal fusion procedures as an adjunctive graft material.
• Use in revision orthopedic procedures to manage localized bone loss.

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 material is intended for defects that are not essential to the mechanical stability of the bone; fixation or structural grafting may be needed for unstable defects.
• It combines calcium sulfate pellets with demineralized bone matrix and should be handled according to the product labeling and sterile surgical technique.
• The appropriate amount and pellet configuration depend on the size and shape of the defect; excessive packing may interfere with wound or fluid management.
• Compatibility with fixation hardware, other graft materials, antibiotics, or biologic products should be confirmed from the current labeling and institutional protocol.
• MRI safety information is device- and labeling-dependent; the current manufacturer instructions should be reviewed before an MRI examination.