Browse hierarchy: [Neurology (NE)](/submissions/NE) → [Subpart F — Neurological Therapeutic Devices](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices) → [21 CFR 882.5360](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5360) → HBW — Fastener, Plate, Cranioplasty

# HBW · Fastener, Plate, Cranioplasty

_Neurology · 21 CFR 882.5360 · Class 2_

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

## Overview

- **Product Code:** HBW
- **Device Name:** Fastener, Plate, Cranioplasty
- **Regulation:** [21 CFR 882.5360](/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/882.5360)
- **Device Class:** 2
- **Review Panel:** [Neurology](/submissions/NE)
- **Implant:** yes

## Identification

A cranioplasty plate fastener is a screw, wire, or other article made of tantalum, vitallium, or stainless steel used to secure a plate to the patient's skull to repair a skull defect.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (7 of 7)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K251472](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW/K251472.md) | Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System | Inion OY | Jul 11, 2025 | SESE |
| [K231208](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW/K231208.md) | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | Aug 14, 2023 | SESE |
| [K171152](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW/K171152.md) | Stryker Universal Neuro III System AXS Screw | Stryker | May 19, 2017 | SESE |
| [K151387](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW/K151387.md) | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | Stryker | Jun 24, 2015 | SESE |
| [K141385](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW/K141385.md) | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | Depuy Synthes Companies of Johnson & Johnson | Mar 27, 2015 | SESE |
| [K101835](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW/K101835.md) | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | Porex Surgical, Inc. | Dec 3, 2010 | SESE |
| [K001353](https://fda.innolitics.com/submissions/NE/subpart-f%E2%80%94neurological-therapeutic-devices/HBW/K001353.md) | MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM | Biomedical Ent., Inc. | Mar 13, 2001 | SESE |

## Top Applicants

- Stryker — 2 clearances
- Biomedical Ent., Inc. — 1 clearance
- Depuy Synthes Companies of Johnson & Johnson — 1 clearance
- Inion OY — 1 clearance
- Porex Surgical, Inc. — 1 clearance

---

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

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com