BONE CEMENT FOR CRANIOPLASTY

K040152 · Cardinalhealth · GXP · May 19, 2004 · Neurology

Device Facts

• Record ID: K040152
• Device Name: BONE CEMENT FOR CRANIOPLASTY
• Applicant: Cardinalhealth
• Product Code: GXP · Neurology
• Decision Date: May 19, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Resinous Material for repairing cranial defects.

Device Story

Bone Cement for Cranioplasty is a self-curing acrylic resinous material used by surgeons to repair skull defects. The device consists of two sterile components, a liquid and a powder, which are mixed intraoperatively to form the cement. Once mixed, the material is applied to the cranial defect site where it cures to provide structural repair. The device is intended for use in a clinical setting by a surgeon.

Clinical Evidence

No clinical data. Substantial equivalence was established based on non-clinical performance testing demonstrating functional equivalence to the predicate device.

Technological Characteristics

Self-curing acrylic resin consisting of two sterile components (liquid and powder). The device is a methyl methacrylate for cranioplasty (21 CFR 882.5300).

Indications for Use

Indicated for the repair of cranial defects.

Regulatory Classification

Identification

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

Predicate Devices

• Codman Cranioplastic, Acrylic Cranioplasty Material (K873689)

Submission Summary (Full Text)

{0}------------------------------------------------

K040152

MAY 1 9 2004

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of four curved lines that resemble the flight of a bird. The text "CardinalHealth" is written in a simple, sans-serif font.

Cardinal Health 1500 Waukegan Road
McGaw Park, Illinois 60085-6787 847.473.1500

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Bone Cement

| Sponsor: | Cardinal Health<br>1500 Waukegan Road - MPWM<br>McGaw Park, IL 60085 |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Sharon Nichols<br>Manager, Regulatory Affairs |
| Telephone: | [phone] |
| Date Prepared: | January, 2004 |
| Product Trade Name: | Bone Cement |
| Common Name: | Methyl Methacrylate for Cranioplasty |
| Classification: | Class II per 21 CFR §882.5300 |
| Predicate Device: | Codman Cranioplastic |
| Intended Use: | Resinous Material for repairing cranial defects |
| Substantial Equivalence: | This device is substantially equivalent to the Codman Cranioplastic,<br>Acrylic Cranioplasty Material (K873689). |
| Description: | Bone Cement for Cranioplasty (skull repair) is a self-curing acrylic<br>that a surgeon uses to repair a skull defect in a patient. It is<br>comprised of two sterile components (liquid and powder), which are<br>mixed to form the cement. |
| Summary of testing: | Based on the product performance information provided to FDA, the<br>subject device has been shown to be substantially equivalent to the<br>currently marketed predicate device. |
| Non-clinical Test Results: | Performance testing demonstrated that the proposed Bone Cement<br>is substantially equivalent to currently marketed Cranioplastic with<br>regard to functional characteristics. |

Image /page/0/Picture/6 description: The image shows a sequence of numbers, specifically '000692'. The numbers are printed in a clear, bold font, making them easily readable. The sequence appears to be a numerical code or identifier, possibly a serial number or a reference number.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird with three wing-like shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 9 2004

Sharon Nichols Regulatory Affairs Manager Cardinal Health 1500 Waukegan Road McGaw Park, Illinois 60085

Re: K040152

Trade/Device Name: Bone Cement for Cranioplasty Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: April 12, 2004 Received: April 13, 2004

Dear Ms. Nichols:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

{2}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,

O Mula A. Mullan

Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Cardinal Health 1500 Waukegan Road McGaw Park, Illinois 60085-6787 847.473.1500 FAX: [phone]

Image /page/3/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of several curved lines that converge and overlap, resembling abstract wings or a stylized bird in flight. The text "CardinalHealth" is written in a simple, sans-serif font, with "Cardinal" in bold and "Health" in a regular weight.

## INDICATION FOR USE

510(k) Number (if known): K040152

Device Name:

Bone Cement for Cranioplasty

Indications For Use: defects.

Resinous Material for repairing cranial

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The Counter Use or (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K040152