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) → PBJ — Cranial Distraction System

# PBJ · Cranial Distraction System

_Neurology · 21 CFR 882.5330 · Class 2_

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

## Overview

- **Product Code:** PBJ
- **Device Name:** Cranial Distraction System
- **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
- **Life-sustaining:** 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 (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K230211](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PBJ/K230211.md) | CranioXpand | KLS-Martin L.P. | Nov 21, 2023 | SESE |
| [K170818](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PBJ/K170818.md) | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | Dec 7, 2017 | SESE |
| [K163315](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PBJ/K163315.md) | Internal Distraction - Sterile | KLS Martin L.P. | May 5, 2017 | SESE |
| [K150771](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PBJ/K150771.md) | RxG Distraction System | KLS Martin L.P. | Aug 27, 2015 | SESE |
| [K123885](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PBJ/K123885.md) | OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR | Osteomed LP | Jun 3, 2013 | SESE |
| [K121304](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/PBJ/K121304.md) | OSTEOMED CRANIAL DISTRACTION SYSTEM | Osteomed | Aug 22, 2012 | SESE |

## Top Applicants

- KLS Martin L.P. — 2 clearances
- KLS-Martin L.P. — 1 clearance
- Osteomed — 1 clearance
- Osteomed LP — 1 clearance
- Synthes USA Products, LLC — 1 clearance

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

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