MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280

K071791 · Codman & Shurtleff, Inc. · GXP · Jul 30, 2007 · Neurology

Device Facts

• Record ID: K071791
• Device Name: MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280
• Applicant: Codman & Shurtleff, Inc.
• Product Code: GXP · Neurology
• Decision Date: Jul 30, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cranioplastic® is indicated for the repair of cranial defects.

Device Story

Cranioplastic® is a self-curing, methylmethacrylate (MMA)-based acrylic resin used for the repair of cranial defects. The device consists of powder and liquid components that are mixed to form an acrylic cement. It is intended for use by clinicians in a surgical setting. The material is applied to the cranial defect site, where it cures to provide structural repair. The device is a modification of a previously cleared formulation.

Technological Characteristics

Self-curing methyl methacrylate (MMA) based acrylic resin. Consists of powder and liquid components. Class II device (21 CFR 882.5300).

Indications for Use

Indicated for the repair of cranial defects in patients requiring cranioplasty.

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

• Cranioplastic® (K873689)
• SmartSet GMV Endurance Gentamicin Bone Cement (K033382)

Submission Summary (Full Text)

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K071791/

#### 510K SUMMARY SECTION 4

| NAME OF FIRM: | JUL 30 2007<br>Codman & Shurtleff, Inc.<br>325 Paramount Drive<br>Raynham<br>MA 02767-0350 |
|--------------------------------------|--------------------------------------------------------------------------------------------|
| 510(k) CONTACT: | Rachel Creane<br>Senior Regulatory Affairs Specialist |
| TRADE NAME: | Cranioplastic® |
| COMMON NAME: | Methyl Methacrylate (MMA) |
| CLASSIFICATION: | Class II; 21 CFR 882.5300 |
| DEVICE PRODUCT CODE: | GXP |
| SUBSTANTIALLY EQUIVALENT<br>DEVICES: | Cranioplastic®(K873689)<br>SmartSet GMV Endurance Gentamicin Bone Cement<br>(K033382) |

### DEVICE DESCRIPTION:

Cranioplastic® is a self-curing, methylmethacrylate (MMA) based acrylic resin, for repairing cranial defects. The following modifications are being made:

A change is being made to the formulation of the liquid and powder components of the acrylic cement and the Instructions for Use (IFU) is being updated.

# INTENDED USE AND INDICATIONS:

Cranioplastic® is indicated for the repair of cranial defects.

## BASIS OF SUBSTANTIAL EQUIVALENCE:

The substantial equivalence of Cranioplastic® to the identified predicate devices is demonstrated by its similarity in terms of technological characteristics (chemical composition, material properties, performance characteristics, manufacture, packaging and sterilization) to Cranioplastic® (K873689) and SmartSet GMV Endurance Gentamicin Bone Cement (K033382).

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is oriented to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2007

Codman & Shurtleff, Inc. % Ms. Rachel Creane Senior Regulatory Affairs Specialist 325 Paramount Drive Raynham, MA 02767-0350

Re: K071791

Trade/Device Name: Cranioplastic® Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: June 28, 2007 Received: July 02, 2007

Dear Ms. Creane:

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 does 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.

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Page 2 -- Ms. Rachel Creane

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrl/industry/support/index.html

Sincerely yours,

Barbara Buehrig

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### SECTION 5 INDICATIONS STATEMENT

510(k) Number (if known):

Device Name: Cranioplastic®

Indications for Use:

Cranioplastic® is indicated for the repair of cranial defects.

Prescription Use ਮ (Part 21 CFR 801.Subpart D)

OR

Over-The Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

barbare buchun

Division of General, Restorative, and Neurological Devices

510(k) Number K071791