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Filler, Bone Void, Non-Alterable Compound For Cranioplasty

FDA product code PJN · 2 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.5330
Review panel
NE
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2019-10-10 – 2021-10-01

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.

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