PJN — Filler, Bone Void, Non-Alterable Compound For Cranioplasty Class II
FDA product code PJN covers "Filler, Bone Void, Non-Alterable Compound For Cranioplasty", a Class II medical device regulated under 21 CFR 882.5330. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PJN
- Device Class
- Class II
- Regulation Number
- 882.5330
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
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.