HBW · Fastener, Plate, Cranioplasty
Neurology · 21 CFR 882.5360 · Class 2
Overview
| Product Code | HBW |
|---|---|
| Device Name | Fastener, Plate, Cranioplasty |
| Regulation | 21 CFR 882.5360 |
| Device Class | Class 2 |
| Review Panel | Neurology |
| 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 | 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 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | Aug 14, 2023 | SESE |
| K171152 | Stryker Universal Neuro III System AXS Screw | Stryker | May 19, 2017 | SESE |
| K151387 | Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade | Stryker | Jun 24, 2015 | SESE |
| K141385 | DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS) | Depuy Synthes Companies of Johnson & Johnson | Mar 27, 2015 | SESE |
| K101835 | MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 | Porex Surgical, Inc. | Dec 3, 2010 | SESE |
| K001353 | 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
