Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5320](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5320) → PJM — Filler, Bone Void, Alterable Compound For Cranioplasty

# PJM · Filler, Bone Void, Alterable Compound For Cranioplasty

_Neurology · 21 CFR 882.5320 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PJM

## Overview

- **Product Code:** PJM
- **Device Name:** Filler, Bone Void, Alterable Compound For Cranioplasty
- **Regulation:** [21 CFR 882.5320](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5320)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **Implant:** yes

## Identification

A preformed alterable cranioplasty plate is a device that is implanted into a patient to repair a skull defect. It is constructed of a material, e.g., tantalum, that can be altered or reshaped at the time of surgery without changing the chemical behavior of the material.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PJM](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PJM)

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