Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5330](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5330) → PJN — Filler, Bone Void, Non-Alterable Compound For Cranioplasty

# PJN · Filler, Bone Void, Non-Alterable Compound For Cranioplasty

_Neurology · 21 CFR 882.5330 · Class 2_

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

## Overview

- **Product Code:** PJN
- **Device Name:** Filler, Bone Void, Non-Alterable Compound For Cranioplasty
- **Regulation:** [21 CFR 882.5330](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5330)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **Implant:** yes

## Identification

A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot 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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K212414](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PJN/K212414.md) | OSSDSIGN Cranial PSI | Ossdsign AB | Oct 1, 2021 | SESE |
| [K190523](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PJN/K190523.md) | Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial | Ossdsign AB | Oct 10, 2019 | SESE |

## Top Applicants

- Ossdsign AB — 2 clearances

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

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