Filler, Bone Void, Alterable Compound For Cranioplasty
PJM · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5320
Classification
FDA Product Code
PJM
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5320
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.