SOLITAIRE ANTERIOR SPINAL SYSTEM

K062810 · Ebi, L.P. · MQP · Oct 17, 2006 · Orthopedic

Device Facts

• Record ID: K062810
• Device Name: SOLITAIRE ANTERIOR SPINAL SYSTEM
• Applicant: Ebi, L.P.
• Product Code: MQP · Orthopedic
• Decision Date: Oct 17, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire Spine System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

Device Story

Vertebral body replacement system; used in thoracolumbar spine (T10-L5). Replaces diseased or fractured vertebral bodies; restores spinal column height and biomechanical integrity. Implanted by surgeons during spinal procedures. System provides structural support to anterior, middle, and posterior spinal columns; functions even without fusion. Device design modification of existing spinal systems.

Clinical Evidence

Bench testing only; comparative mechanical performance data demonstrated the system meets design requirements established by predicate devices.

Technological Characteristics

Vertebral body replacement system; mechanical spinal fixation device. Design specifications based on predicate devices. No specific materials or software algorithms described.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T10-L5) due to tumors or fractures. Used to achieve anterior decompression and restore vertebral height and biomechanical integrity.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Interpore Cross International Anterior Fixation Device (AFD)
• Interpore Cross International Expandable PEEK VBR System
• EBI ESL Spine Spacer System

Submission Summary (Full Text)

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K062-810 1/2

## EBI, L.P./Biomet Spine

## Solitaire" Anterior Spinal System

OCT 1 7 2006

| SUBMITTER: | EBI, L.P. |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ADDRESS: | 100 Interpace Parkway<br>Parsippany, NJ 07054 |
| PHONE: | [phone] |
| FAX: | [phone] |
| CONTACT PERSON: | Debra L. Bing<br>Director, Regulatory Affairs |
| SUBMISSION PREPARED BY: | Jennifer P. Harakal |
| DATE PREPARED: | September 8, 2006 |
| TRADE NAME: | Solitaire™ Anterior Spinal System |
| COMMON NAME: | Vertebral Body Replacement |
| CLASSIFICATION NAME: | Vertebral Body Replacement |
| PREDICATE DEVICE: | -Interpore Cross International Anterior Fixation Device<br>(AFD)<br>-Interpore Cross International Expandable PEEK VBR<br>System<br>-EBI ESL Spine Spacer System |

#### INTENDED/INDICATIONS FOR USE:

The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., T10 to L5) to replace a diseased vertebral body resected or excised for the treatment of turnors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Solitaire Spine System is also indicated for treating fractures of the thoracic and lumbar spine. The Solitaire Spine System is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

### TECHNOLOGICAL CHARACTERISTICS:

## Performance Testing

Performance data comparatively evaluating the modified system to its predicate devices demonstrate that the proposed system adequately meets the requirements established in design specifications for its mechanical performance. The design requirements were established based on those of the previously cleared predicate devices.

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#### Substantial Equivalence

The Solitaire Anterior Spinal System is substantially equivalent to its predicate devices with respect to intended use and indications, technological characteristics, and basic principles of operation. This premarket notification is being submitted to address a design modification, as well operation. This premarker notification is being system. As demonstrated by performance data, as to renect additional components to assess any hew issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of flowing lines, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EBI, LP % Ms. Debra Bing Director, Regulatory Affairs 100 Interpace parkway Parsippany, New Jersey 07054

OCT 1 7 2006

Re: K062810

Trade/Device Name: Solitaire™ Anterior Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Fixation Device Regulatory Class: Class II Product Code: MQP Dated: September 15, 2006 Received: September 19, 2006

Dear Ms Bing:

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, and 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. Debra Bing

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 Buchm

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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# 11

# Indications for Use Statement

510(k) Number (if known):

Device Name: Solitaire™ Anterior Spinal System i

Indications for Use:

The Solitaire Anterior Spinal System is indicated for use in the thoracolumbar spine (i.e., TIA to L.S) to replace a diseased vertebral body resected or excised for the treament of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the thoracis achieve anterior decompression of the Spinar core tax indicated for treating fractures of the thoracity of the collapsed vertebral body. The Sollaire System is designed to restore the biomechanical integrity of the and lumbar spine. The Soltane System is dosigned to reneve of fusion for a prolonged period.

Prescription Use X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

K06.2810(koubaue Pueeuno

(Division Sign-Of Division of General. Restorative, and Neurological Devices

**510(k) Number** K062810