Filler, Bone Void, Non-Alterable Compound For Cranioplasty
PJN · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5330
Classification
FDA Product Code
PJN
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.5330
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
A nonalterable cranial bone void filler is a device that is created from patient-specific computerized tomography (CT) imaging data and intended to fill 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 materials used (e.g., metals, polyether ether ketone (PEEK), etc.) in the construction of the nonalterable cranial bone void fillers are not resorbable and cannot be altered or reshaped at the time of surgery or after implantation without changing the chemical behavior of the material.