EBI ESL PEEK-OPTIMA SPINE SYSTEM

K061016 · Ebi, L.P. · MQP · Jun 8, 2006 · Orthopedic

Device Facts

• Record ID: K061016
• Device Name: EBI ESL PEEK-OPTIMA SPINE SYSTEM
• Applicant: Ebi, L.P.
• Product Code: MQP · Orthopedic
• Decision Date: Jun 8, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ESL® PEEK-OPTIMA® is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of 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 ESL® PEEK-OPTIMA® is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® 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

The ESL® PEEK-OPTIMA® Spine System is a vertebral body replacement device used in the thoracolumbar spine. It serves as a structural implant to replace diseased or fractured vertebral bodies, facilitating anterior decompression of neural tissues and restoration of spinal height. The device is designed to restore biomechanical integrity to the spinal column, functioning even in the absence of fusion. It is intended for use by surgeons in a clinical/surgical setting. The system consists of PEEK-OPTIMA® spacers added to the existing ESL Spine Spacer System. The device provides mechanical support to the anterior, middle, and posterior spinal columns.

Clinical Evidence

Bench testing only.

Technological Characteristics

Constructed from PEEK-OPTIMA® polymer. Designed as a vertebral body replacement spacer for the thoracolumbar spine. Mechanical properties verified via bench testing to ensure equivalence to existing metallic or PEEK-based spinal spacers.

Indications for Use

Indicated for patients with diseased or fractured vertebral bodies in the thoracolumbar spine (T1-L5) requiring partial vertebral body replacement for tumor resection or fracture treatment.

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

• EBI® ESL® Spine Spacer System
• Interpore Cross International PEEK CAS

Submission Summary (Full Text)

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K061016

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# 510(k) Summary EBI® ESL® PEEK-OPTIMA® Spine System

JUN - 8 2006

| Proprietary Name: | ESL® PEEK-OPTIMA® Spine System |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Vertebral Body Replacement Device |
| Classification Name: | Spinal Intervertebral Fixation Orthosis, 21<br>CFR §888.3030 |
| Product Code: | MQP |
| Predicate Device(s): | EBI® ESL® Spine Spacer System<br>Interpore Cross International PEEK CAS |
| Contact Information: | Jennifer Harakal, Regulatory Affairs Specialist<br>EBI, L.P.<br>100 Interpace Parkway<br>Parsippany, NJ 07054<br>Phone: [phone] x2156 |
| Date Summary Prepared: | May 15, 2006 |

### Indications for Use

The ESL® PEEK-OPTIMA® is indicated for use in the thoracolumbar spine (i.e., T1 to L.5) for partial replacement of 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 ESL® PEEK Spine Spacer System is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® 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 Description

This Special 510(k) submission is intended to reflect the addition of PEEK spacers to the existing ESL Spine Spacer System.

### Substantial Equivalence

The subject ESL PEEK-OPTIMA Spine System is similar to its predicate devices with respect to intended use and basic design. Mechanical testing demonstrated comparable mechanical properties to the predicate components.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2006

EBI, LP % Ms. Jennifer P. Harakal Regulatory Affairs Specialist 100 Interpace Parkway Parsippany, New Jersey 07054

Re: K061016

Trade/Device Name: EBI® ESL® PEEK-OPTIMA® Spine System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: May 17, 2006 Received: May 18, 2006

Dear Ms. Harakal:

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 (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.

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Page 2 - Ms. Jennifer P. Harakal

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,

Hucker Lemar no

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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#### Indications for Use

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Device Name: EBI® ESL® PEEK-OPTIMA® Spine System

Indications For Use:

The ESL® PEEK-OPTIMA® is indicated for use in the thoracolumbar spine (i.e., T1 to L5) for partial replacement of 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 ESL® PEEK-OPTIMA® is also indicated for partial vertebral body replacement for the treatment of fractures of the thoracic and lumbar spine. The ESL® PEEK-OPTIMA® 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.

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

Over-The-Counter

(21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Huber Romer

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K061016