LIFE SPINE CEMENT RESTRICTOR

K060247 · Life Spine · JDK · May 11, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060247
• Device Name: LIFE SPINE CEMENT RESTRICTOR
• Applicant: Life Spine
• Product Code: JDK · General, Plastic Surgery
• Decision Date: May 11, 2006
• Decision: SESU
• Submission Type: Traditional
• 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

Life Spine Cement Restrictor; straight or tapered hollow box with fenestrated surface; exterior teeth prevent migration. Manufactured from PEEK-OPTIMA. Used in orthopedic surgeries to contain bone cement within femoral canal, tibia, or humerus. Surgeon selects size based on patient anatomy. Device acts as physical barrier to restrict cement flow. No software or electronic components.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility certified to ISO 10993.

Technological Characteristics

Straight or tapered hollow box; fenestrated surface; exterior teeth for fixation. Material: PEEK-OPTIMA per ASTM F 2026-02. Non-load bearing. Class II device (21 CFR 878.3300).

Indications for Use

Indicated for use as a cement restrictor in the femur, tibia, or humerus during orthopedic surgery. Not for spinal indications 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

• SIGNUS Medical RABEA™ Cement Restrictor

Submission Summary (Full Text)

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

Page 1 of 2 K060247

## 510(k) Summary of Safety and Effectiveness

MAY 11 2006

| Submitted By: | Life Spine<br>2400 Hassel Road Suite 370<br>Hoffman Estates, IL 60195<br>Telephone: [phone]<br>Fax: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact: | Erin Malloy<br>Life Spine<br>2400 Hassel Road Suite 370<br>Hoffman Estates, IL 60195 |
| Date Prepared: | January 30, 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: | SIGNUS Medical RABEA™ Cement Restrictor |

#### 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

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

## 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.

This device is manufactured from PEEK-OPTIMA®. The previously cleared SIGNUS Medical RABEA™ Cement Restrictor was also manufactured from PEEK-OPTIMA®, which complies with ASTM F2026. The biocompatibility of this material for implantable contact over 30 days has been certified to ISO 10993 by the manufacturer of PEEK-OPTIMA®, Invibio. The Food and Drug Administration retains a Device Master File containing the biocompatibility information.

#### Substantial Equivalence:

The Life Spine Cement Restrictor was shown to be substantially equivalent to previously cleared device, the SIGNUS Medical RABEA™ Cement Restrictor, in indications for use, design, function, and materials used.

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

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 seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three stylized, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 11 2006

Life Spine c/o Erin Malloy 2400 Hassell Road - Suite 370 Hoffman Estates, Illinois 60195

Re: K060247 : 分 : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : Life Spine Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDK Dated: March 17, 2006 Received: March 20, 2006

Dear Ms. Malloy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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 (PMA) application. You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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 unse 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 Wamingson than 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.

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

Page 2 - Ms. Erin Malloy

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. 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/cdrl/industry/support/index.html.

Sincerely yours,

Donna Bea Tillman, Ph.D., M.P.A.

Donna-Bea Tillman, Ph.D., M.P.A Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

#### 510(k) number (if known): K060247

#### 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)

Mark N. Wilkerson

ision Sign-Off) Timesion of General, Restorative and Neurological Devices

Number K060247

Submitted: 01-30-06

CONFIDENTIAL

Property of Life Spine