FDA product code PJM: Filler, Bone Void, Alterable Compound For Cranioplasty
PJM is the FDA product code for filler, bone void, alterable compound for cranioplasty. It is a Class II device, regulated under 21 CFR 882.5320 and reviewed by the Neurology panel. Devices under PJM reach the market by 510(k); FDA lists no cleared 510(k)s for it.
Definition
An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of 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 device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or after implantation without changing the chemical behavior of the material.
Classification
| Field | Value |
|---|---|
| Device name | Filler, Bone Void, Alterable Compound For Cranioplasty |
| Device class | Class II |
| Regulation | 21 CFR 882.5320 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
Recalls for PJM devices
openFDA lists no recalls for product code PJM.
Frequently asked questions
What is FDA product code PJM?
PJM is the FDA product code for filler, bone void, alterable compound for cranioplasty. It is a Class II device, regulated under 21 CFR 882.5320 and reviewed by the Neurology panel.
What device class is PJM?
Class II, regulation 21 CFR 882.5320. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code PJM
- Run a recall and safety report across every PJM manufacturer
- Watch product code PJM 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.