VERTEFIX VERTEBROPLASTY PROCEDURE SET

K042691 · Cook, Inc. · NDN · Nov 8, 2005 · Orthopedic

Device Facts

• Record ID: K042691
• Device Name: VERTEFIX VERTEBROPLASTY PROCEDURE SET
• Applicant: Cook, Inc.
• Product Code: NDN · Orthopedic
• Decision Date: Nov 8, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Vertefix™ Radiopaque Bone Cement is indicated for the fixation of vertebral compression fractures during a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

Device Story

Vertefix™ Vertebroplasty Procedure Set comprises a Vertebroplasty Injector Kit and Vertefix™ Radiopaque Bone Cement. Cement consists of two premeasured components: 20g polymer powder and 9.2g liquid monomer. Powder includes 30% barium sulfate for radiopacity. Used by physicians in clinical settings to perform vertebroplasty procedures. Device functions as a bone filler to stabilize vertebral compression fractures. Benefits include pain relief and structural stabilization of the vertebral body.

Clinical Evidence

Bench testing only. Testing included material and chemical analyses, mechanical testing, and biocompatibility assessments to ensure conformance to requirements for bone cement use.

Technological Characteristics

PMMA bone cement; 20g polymer powder, 9.2g liquid monomer; 30% barium sulfate radiopacifier. Class II device per 21 CFR 888.3027. Sterilized components.

Indications for Use

Indicated for fixation of vertebral compression fractures in patients with pain due to osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).

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 Corp. Spineplex™ Radiopaque Bone Cement (K032945)
• Kyphon, Inc. KyphX® HV-R Bone Cement Model C01A (K041584)

Submission Summary (Full Text)

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K 04269//

NOV - 8 2005

Cook Incorporated P.O. Box 489 Bloomington, IN 47402-0489 Phone: [phone] www.cookgroup.com

## 510(k) SUMMARY

| Submitted By: | COOK INCORPORATED<br>750 Daniels Way, P.O. Box 489<br>Bloomington, IN 47402-0489 |
|--------------------------|----------------------------------------------------------------------------------|
| Contact Person: | Earl E. Knight III, MPA<br>Tel: [phone] Fax: [phone] |
| Date Prepared: | September 28, 2004 |
| Device: | |
| Trade Name: | Vertefix™ Vertebroplasty Procedure Set |
| Common/Usual Name | Filler, Bone Cement (For Vertebroplasty) |
| Proposed Classification: | Polymethylmethacrylate (PMMA) Bone Cement<br>21 CFR §888.3027, Class II |
| Product Code/Panel Code: | NDN—Orthopedic |

## Intended Use:

Vertefix™ Radiopaque Bone Cement is indicated for the fixation of vertebral compression fractures during a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

## Predicate Devices:

| Manufacturer | Device Name | 510(k) # |
|---------------|------------------------------------|----------|
| Stryker Corp. | Spineplex™ Radiopaque Bone Cement | K032945 |
| Kyphon, Inc. | KyphX® HV-R Bone Cement Model C01A | K041584 |

# Device Description:

The Vertefix™ Vertebroplasty Procedure Set contains the Vertebroplasty Injector Kit and Vertefix™ Radiopaque Bone Cement. The bone cement consists of two separate, premeasured sterilized components: 20g polymer powder and 9.2g liquid monomer. The powder contains 30% barium sulfate as a radiopacifier.

## Substantial Equivalence:

The subject device is similar with respect to intended use, chemical composition, and fundamental scientific technology of commercially available predicate devices in terms of section 510(k) substantial equivalence; any differences that may exist do not significantly affect the safety and effectiveness of the device.

# Non-Clinical Test Data:

The results of these tests provide reasonable assurance that Vertefix™ Radiopaque Bone Cement has been designed and tested to assure conformance to the requirements for its use as a bone cement. Testing conducted on the device includes: material and chemical analyses, mechanical testing, and biocompatibility,

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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 the HHS logo, which consists of a stylized caduceus with three snakes intertwined around a staff. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 2005

Thalia Brine Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402-1379

Re: K042691

Trade/Device Name: Vertefix™ Vertebroplasty Procedure Set Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: NDN Dated: October 4, 2005 Received: October 6, 2005

Dear Ms. Brine:

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 - Thalia Brine

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/industry/support/index.html.

Sincerely yours,

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

Enclosure

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#### Indications for Use Statement

510(k) Number (if known): __ K C+ 乙 bq ) =====================================================================================================================================

Device Name: Vertefix™ Vertebroplasty Procedure Set

Indications for Use:

Vertefix™ Radiopaque Bone Cement is indicated for the fixation of vertebral compression fractures during a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

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

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

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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_LCG & CLC