MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR

K061698 · Life Spine · JDK · Jul 12, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K061698
• Device Name: MODIFICATION TO LIFE SPINE CEMENT RESTRICTOR
• Applicant: Life Spine
• Product Code: JDK · General, Plastic Surgery
• Decision Date: Jul 12, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Life Spine Cement Restrictor is intended for use in orthopedic surgeries involving the femoral canal, tibia, or the humerus. This device is NOT intended for use in any spinal indications or acetabular cup surgeries. The safety and effectiveness of this device for implantation in the spine has not been established.

Device Story

The Life Spine Cement Restrictor is a hollow, straight or tapered box with a fenestrated surface; designed to contain bone cement within the femoral canal, tibia, or humerus. The exterior features teeth to prevent migration from the implantation site. The device is available in various sizes to accommodate patient anatomy, as determined by the surgeon. It is a non-load bearing implant used during orthopedic procedures to restrict the flow of bone cement.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manufactured from PEEK-OPTIMA® per ASTM F 2026-02. Geometry is a straight or tapered hollow box with fenestrations and exterior teeth for fixation. Non-load bearing device.

Indications for Use

Indicated for use as a cement restrictor in the femur, tibia, or humerus during orthopedic surgery. Not indicated for spinal applications or acetabular cup surgeries.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• Previously cleared devices

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line is underneath the word "Spine". A registered trademark symbol is to the right of the word "Spine".

K061698 P& LOF Z

| Special 510(k) Summary of Safety and Effectiveness | | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------|
| 510(k) Summary - Life Spine Cement Restrictor | | |
| Submitted By: | Life Spine<br>2400 Hassell Road, Suite 370<br>Hoffman Estates, IL 60195<br><br>Telephone: [phone]<br>Fax: [phone] | JUL 1 2 2006 |
| 510(k) Contact: | Erin Malloy<br>Life Spine<br>2400 Hassell Road, Suite 370<br>Hoffman Estates, IL 60195 | |
| Date Prepared: | June 15, 2006 | |
| Trade Name: | Life Spine Cement Restrictor | |
| Common Name: | Cement Restrictor | |
| Classification: | Prosthesis, Surgical Mesh<br>CFR 878.3300<br>Class II | |
| Device Product Code: | JDK | |
| Predicate Device: | Previously cleared devices | |

#### Device Description:

The device is a straight or tapered hollow box with a fenestrated surface on many sides. The geometry is designed to contain bone cement. The exterior surface of the device has teeth to prevent the device from migrating from the desired location. The device is manufactured from PEEK-OPTIMA®. The device is made in a variety of sizes. The responsible surgeon will determine the correct size of the device in accordance with the anatomical size of the individual patient.

# WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

# THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED

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Image /page/1/Picture/0 description: The image shows the words "Life Spine" in a bold, sans-serif font. The word "Life" is in a larger font size than the word "Spine". There is a curved line underneath the word "Spine", and the registered trademark symbol is to the right of the word "Spine".

#### Intended Use of the Device:

The Life Spine Cement Restrictor is intended for use in orthopedic surgeries involving the femoral canal, tibia, or the humerus.

This device is NOT intended for use in any spinal indications or acetabular cup surgeries. The safety and effectiveness of this device for implantation in the spine has not been established.

### Material:

The Life Spine Cement Restrictor is manufactured from PEEK-OPTIMA® according to ASTM F 2026-02.

### Performance Data:

This is designated as a non-load bearing Class II device under CFR 21 878.3300 and no mechanical tests are required.

#### Substantial Equivalence:

The Life Spine Cement Restrictor was shown to be substantially equivalent to previously cleared devices in indications for use, design, function, and materials used.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three abstract shapes that resemble birds in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 2 2006

Life Spine LLC % Ms. Erin Malloy Project Engineer 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195

Re: K061698

Trade/Device Name: Life Spine Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: JDK Dated: June 15, 2006 Received: June 16, 2006

Dear Ms. Malloy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your 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 10 mo been in 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's package insert and also as a Warning on the product label:

WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.

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#### Page 2 - Ms. Erin Malloy

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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,

Barbara Buell MD

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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Image /page/4/Picture/0 description: The image shows the logo for Life Spine. The words "Life Spine" are written in a bold, sans-serif font. A curved line is underneath the word "Spine". The registered trademark symbol is next to the word "Spine".

KØ61698

## Indications for Use

510(k) number (if known): ________

Device Name: Life Spine Cement Restrictor

The Life Spine Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, or humerus.

This device is not intended for spinal indications or acetabular cup surgeries. The safety and effectiveness of this device when implanted in the spine have not been established.

WARNING: THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS.

### THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED

Prescription Use x (Part 21 CFR 801 Subpart D) And/Or

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

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

K061698 Barbara Buehno

(Divis Division of General, Restor and Neurological Devices

**510(k) Number** K061196