RELIEVE LAMINOPLASTY FIXATION SYSTEM

K080664 · Globus Medical, Inc. · NQW · Jul 25, 2008 · Orthopedic

Device Facts

• Record ID: K080664
• Device Name: RELIEVE LAMINOPLASTY FIXATION SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: NQW · Orthopedic
• Decision Date: Jul 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RELIEVE™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE™ Laminoplasty Fixation System is used to hold the bone allograft material in place in order to prevent the allograft from expulsion, or impinging the spinal cord.

Device Story

RELIEVE™ Laminoplasty Fixation System consists of spinal fixation plates and screws; used in posterior cervical or thoracic laminoplasty procedures. Implants available in various sizes/geometries to fit patient anatomy. Plates secure bone allograft material to prevent expulsion or spinal cord impingement. Screws attach plates to bone. Operated by surgeons in clinical settings. Device provides mechanical stabilization of bone graft during spinal surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, material, and performance characteristics compared to predicate devices.

Technological Characteristics

Plates: radiolucent polymer with titanium alloy or tantalum markers (ASTM F2026, F136, F1295, F560). Screws: titanium alloy (ASTM F136, F1295). Mechanical fixation system; non-powered; non-implantable software.

Indications for Use

Indicated for patients undergoing laminoplasty procedures in the lower cervical and upper thoracic spine (C3-T3) to secure bone allograft material and prevent expulsion or spinal cord impingement.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Medtronic Sofamor Danek CENTERPIECE Plate Fixation System (K050082)
• Blackstone Laminoplasty Fixation System (K043338)
• Synthes Arch Fixation System (K032534)

Submission Summary (Full Text)

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K080664 (pg. 1 of 1)

# 510(k) SUMMARY: RELIEVE™ Laminoplasty Fixation System

| Company: | Globus Medical Inc.<br>2560 General Armistead Ave.<br>Audubon, PA 19403<br>[phone] | JUL 2 5 2008 |
|-----------------|---------------------------------------------------------------------------------------------------------------|--------------|
| Contact: | Kelly J. Baker, Ph.D<br>Director, Clinical Affairs & Regulatory | |
| Device Name: | RELIEVE™ Laminoplasty Fixation System | |
| Classification: | Product Code NQW. Class II.<br>21 CFR §888.3050 Spinal interlaminal fixation orthosis. | |
| Predicate(s): | Medtronic Sofamor Danek CENTERPIECE Plate Fixation<br>System K050082; Blackstone Laminoplasty Fixation System | |

#### DEVICE DESCRIPTION:

The RELIEVE™ Laminoplasty Fixation System consists of spinal fixation plates and screws for use in laminoplasty procedures. RELIEVE™ implants are inserted through a posterior cervical or thoracic approach, and are available in various sizes and geometric options to fit individual patient anatomy. Plates may be filled with bone graft material. Screws are used to attach the plates to bone and are available in a variety of lengths and diameters to fit patient anatomy.

K043338, and Synthes Arch Fixation System K032534.

RELIEVE™ plates are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560. Screws are made from titanium alloy, as specified in F136 and F1295.

### INTENDED USE:

The RELIEVE™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE™ Laminoplasty Fixation System is used to hold the bone allograft material in place in order to prevent the allograft from expulsion, or impinging the spinal cord.

#### Basis for Substantial Equivalence:

RELIEVE™ Laminoplasty Fixation System is similar in terms of indications, design, materials, and performance, to currently marketed devices.

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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars extending from its back, representing the three levels of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the eagle.

JUL 2 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical, Inc % Kelly J. Baker, Ph.D. Director, Clinical Affairs & Regulatory 2560 General Armistead Avenue Audubon, Pennsylvania 19403

Re: K080664

> Trade/Device Name: RELIEVE™ Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NOW Dated: May 30, 2008 Received: June 02, 2008

#### Dear Dr. Baker:

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 - Kelly J. Baker, Ph.D.

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 prodicate 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-frec number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Milliman

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 Statement

| 510(k) Number: | K080664 | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | |
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RELIEVE™ Laminoplasty Fixation System Device Name:

## INDICATIONS:

The RELIEVE™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures, The RELIEVE™ Laminoplasty Fixation System is used to hold bone allograft material in place in order to prevent the allograft from expulsion or impioging the spinal cord.

Prescription Use X (Per 21 CFR §801.109) Over-The-Counter Use

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

N

(Division Sign-Off) Division of General, Restorative, and Neurological Devi 510(k) Number