FDA product code PJN: Filler, Bone Void, Non-Alterable Compound For Cranioplasty
PJN is the FDA product code for filler, bone void, non-alterable compound for cranioplasty. It is a Class II device, regulated under 21 CFR 882.5330 and reviewed by the Neurology panel. FDA has cleared 2 510(k) submissions under PJN. The average 510(k) review took 140 days (median 140).
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.
Classification
| Field | Value |
|---|---|
| Device name | Filler, Bone Void, Non-Alterable Compound For Cranioplasty |
| Device class | Class II |
| Regulation | 21 CFR 882.5330 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for PJN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 220 |
| 2021 | 1 | 59 |
Compare with all 510(k) review times · Search every PJN clearance
Top PJN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ossdsign AB | 2 | 2021-10-01 |
Most recent PJN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212414 | Ossdsign AB | OSSDSIGN Cranial PSI | 2021-10-01 | 59 |
| K190523 | Ossdsign AB | Cranial PSI Accessory Anatomical Model Original, Cranial PSI Accessory Anatomical Model Modified, Cranial PSI Accessory Plastic Drawing Guide, Cranial PSI Accessory Cranial Implant Trial | 2019-10-10 | 220 |
Recalls for PJN devices
openFDA lists no recalls for product code PJN.
Frequently asked questions
What is FDA product code PJN?
PJN is the FDA product code for filler, bone void, non-alterable compound for cranioplasty. It is a Class II device, regulated under 21 CFR 882.5330 and reviewed by the Neurology panel.
What device class is PJN?
Class II, regulation 21 CFR 882.5330. Typical premarket route: 510(k).
How long does a 510(k) take for product code PJN?
Across 2 cleared submissions the average was 140 days from receipt to decision (median 140).
Which companies have the most PJN clearances?
Ossdsign AB (2).
Next steps
- Run an FDA pathway report with predicate devices for product code PJN
- Run a recall and safety report across every PJN manufacturer
- Watch product code PJN for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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