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Bone Cement for Cranioplasty

FDA 510(k)

Class II (US FDA 510(k))

510(k) K040152

by Cardinalhealth

Identifiers

510(k) Number
K040152 FDA 510(k)
FDA Product Code
GXP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5300 FDA 510(k)
Regulation Number
882.5300 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Methyl Methacrylate for Cranioplasty, classified as a Class II medical device under FDA regulations. It is a self-curing acrylic resin designed to repair cranial defects by filling and stabilizing skull voids. The material provides structural integrity to the cranium following surgical intervention, ensuring long-term stability for the patient.

The device is supplied as two sterile components—a liquid and a powder—which are mixed intraoperatively to form the cement. It is intended for single-use in sterile surgical settings and requires no additional regulatory approval beyond its FDA 510(k) clearance (K040152). The product is regulated under FDA regulation number 882.5300 and is distributed in multiple lot sizes (e.g., 1032347, 3002807091, etc.). No MRI safety classification or reusable designation is specified.

Frequently asked questions

What is the primary purpose of this bone cement in cranioplasty procedures?

This bone cement is designed to repair cranial defects by filling and stabilizing voids in the skull after surgical intervention. It provides structural integrity to the cranium, ensuring long-term stability for the patient following the procedure.

How is this bone cement supplied, and is it intended for single-use?

The device is supplied as two sterile components—a liquid and a powder—which must be mixed intraoperatively to form the cement. It is explicitly intended for single-use in sterile surgical settings only, ensuring patient safety and sterility.

Are there different sizes or models available for this bone cement, and how are they identified?

Yes, this bone cement is distributed in multiple lot sizes, such as 1032347, 3002807091, and others listed in the regulatory data. These lot numbers help identify specific batches, but the device itself does not specify distinct sizes or models beyond the standard formulation for cranioplasty.

Does this bone cement require any special handling or storage conditions?

While the data does not specify exact storage conditions, the device is supplied in sterile components, so it must be stored in a clean, dry environment to maintain sterility until use. Always follow manufacturer guidelines for handling sterile medical devices.

Is this bone cement safe for use in patients who require MRI scans after cranioplasty?

The provided data does not mention MRI safety classification for this bone cement, so its compatibility with MRI scans cannot be confirmed. Clinicians should verify compatibility with their MRI equipment and consult the manufacturer for specific guidance before use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BONE CEMENT FOR CRANIOPLASTY (K040152) — FDA 510(k) | Innolitics, PDF 847473.1500 CardinalHealth - Food and Drug Administration, fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cardinalhealth

Sources (1)

  • FDA 510(k) K040152 24 fields · synced Sep 20, 2026