RADIOPAQUE BONE CEMENT

K043518 · Cardinalhealth · NDN · May 11, 2005 · Orthopedic

Device Facts

• Record ID: K043518
• Device Name: RADIOPAQUE BONE CEMENT
• Applicant: Cardinalhealth
• Product Code: NDN · Orthopedic
• Decision Date: May 11, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.

Device Story

Radiopaque Bone Cement is a self-curing acrylic bone cement. It consists of two sterile components, a liquid and a powder, which are mixed by a surgeon to form the cement. The surgeon injects the prepared cement into the vertebral body of a patient suffering from pathological fractures. The device functions to stabilize the fracture site. It is intended for use in a clinical setting by a surgeon.

Clinical Evidence

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

Technological Characteristics

Self-curing acrylic (PMMA) bone cement. Comprised of two sterile components (liquid and powder) mixed prior to use. Radiopaque. Class II device.

Indications for Use

Indicated for the fixation of pathological fractures of the vertebral body in patients requiring stabilization.

Regulatory Classification

Identification

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”

Predicate Devices

• Stryker Spineplex Radiopaque Bone Cement (K032945)

Submission Summary (Full Text)

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MAY I 1 2005

K043518

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Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.689.8410

Image /page/0/Picture/4 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of four curved lines above the company name. The text "CardinalHealth" is written in a bold, sans-serif font.

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

Cardinal Health Sponsor: 1430 Waukegan Road McGaw Park, IL 60085

> Sharon Nichols Manager, Regulatory Affairs

[phone] Telephone:

Date Prepared: December, 2004

Product Trade Name:

Polymethyl Methacrylate (PMMA) Common Name:

Classification: Predicate Device:

Intended Use:

Contact:

Substantial Equivalence:

Description:

Summary of testing:

Non-clinical Test Results:

McGaw Park, IL 60085

Sharon Nichols

Radiopaque Bone Cement

Class II per 21 CFR §882.5300

Stryker Spineplex Radiopaque Bone Cement

ger, Regulatory Affairs
[phone]

Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.

This device is substantially equivalent to Stryker Spineplex Radiopaque Bone Cement (K032945).

Radiopaque Bone Cement is a self-curing acrylic that a surgeon uses to iniect into the vertebral body of a patient with pathological fractures within a vertebral body. It is comprised of two sterile components (liquid and powder), which are mixed to form the cement.

Based on the product performance information provided to FDA, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.

Performance testing demonstrated that the proposed Radiopaque Bone Cement is substantially equivalent to currently marketed Spineplex with regard to functional characteristics.

00174

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Public Health Service

MAY 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sharon Nichols Regulatory Affairs Manager Cardinal Health 1430 Waukegan Road, WM McGaw Park, Illinois 60085

Re: K043518

Trade/Device Name: Radiopaque Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: April 25, 2005 Received: April 26, 2005

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 Mav 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.

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Page 2- Ms. Sharon Nichols

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter with cation. The FDA finding of substantial equivalence of your device to a legally premaince notificate 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/industry/support/index.html.

Sincerely yours,

Hypt Clurdu

Miriam Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Cardinal Health 1430 Waukegan Road, WM McGaw Park, Illinois 60085 847.689.8410 main 847,785,2506 fax

www.cardinal.com

## CardinalHealth

## Indications for Use

ﯿﮯ

510(k) Number (if known):____K043518

Device Name:_Radiopaque Bone Cement

Indications For Use:

Radiopaque Bone Cement is indicated for the fixation of pathological fractures of the vertebral body.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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) | |
|------------------------------------------------------------|---------|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K043518 |