Filler, Bone Void, Non-Alterable Compound For Cranioplasty
The Non-Alterable Compound Bone Void Filler for Cranioplasty is a patient-specific implant created from CT imaging data, intended to fill bony voids, defects, and contour irregularities in non-load-bearing cranial regions using non-resorbable materials such as metals or PEEK that cannot be reshaped after implantation without altering the material's chemical behavior. It is an FDA Class 2 device regulated under 21 CFR 882.5330, requiring 510(k) clearance, within the Neurology (NE) specialty. The product code is PJN, and it is flagged as an implant. This device is not life-sustaining.
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Basic Information
- Product Code
- PJN
- Device Class
- FDA class 2
- Regulation Number
- 882.5330
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K212414 | OSSDSIGN Cranial PSI | Oct 01, 2021 | Substantially Equivalent | Ossdsign AB |
| K190523 | Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial | Oct 10, 2019 | Substantially Equivalent | Ossdsign AB |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.