Filler, Bone Void, Calcium Compound, Lower Extremity Use, Use On Bone Marrow Lesions
Medical specialty
Unknown
Device class
N
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Ineligible
Definition
Intended to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure. These defects may be surgically created from traumatic injury to the bone including bone marrow lesions.