# Filler, Bone Void, Alterable Compound For Cranioplasty
> **Product code: PJM** · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5320
## Classification
- **FDA Product Code:** PJM
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 882.5320
- **Review panel:** NE
- **Medical specialty:** Neurology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** Y
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 0
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PJM)
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