Filler, Bone Void, Alterable Compound For Cranioplasty
Medical specialty
Neurology
Device class
2
Regulation number
882.5320
Review panel
NE
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or after implantation without changing the chemical behavior of the material.