CITADEL ANTERIOR LUMBAR PLATE SYSTEM

K062836 · Globus Medical, Inc. · KWQ · Dec 19, 2006 · Orthopedic

Device Facts

• Record ID: K062836
• Device Name: CITADEL ANTERIOR LUMBAR PLATE SYSTEM
• Applicant: Globus Medical, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CITADEL™ Anterior Lumbar Plate System is intended for use in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

Device Story

CITADEL™ Anterior Lumbar Plate System; spinal fixation implant. Consists of plates of various lengths; variable or fixed bone screws. Used for anterior or anterolateral approach to lumbar/lumbosacral spine (L1-S1). Provides stabilization for instability caused by fracture, tumor, degenerative disc disease, or other spinal pathologies. Implanted by surgeons in clinical/OR setting. Provides mechanical support to vertebral bodies to facilitate fusion/stability. Benefits patient by addressing spinal instability and associated pain/deformity.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s' (May 3, 2004). No clinical data provided.

Technological Characteristics

Titanium alloy implants (ASTM F136, F1295). System includes plates of various lengths and variable or fixed bone screws. Mechanical fixation device. No software or energy source.

Indications for Use

Indicated for patients requiring anterior or anterolateral spinal fixation of the lumbar and lumbosacral spine (L1-S1) due to instability from fracture, tumor, degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous surgery.

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

• REVERE™ Stabilization System (K061202)
• GATEWAY™ Thoracolumbar Plate System (K062407)
• Medtronic Sofamor Danek Pyramid Plate (K013665)
• Synthes Anterior Tension Band (K022791)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the alphanumeric string "K062836" in a handwritten style. Below this string, there is the text "510(k) - CITADEL™ System". The text is underlined, suggesting it is a title or label associated with the alphanumeric string above.

#### 비. 510(k) Summary

## SUBMITTED BY:

DEC 1 9 2006

Globus Medical Inc. Valley Forge Business Center 2560 General Armistead Ave. Audubon, PA 19403 [phone] Contact: Kelly J. Baker

## DEVICE NAME:

CITADEL™ Anterior Lumbar Plate System

## CLASSIFICATION:

21 CFR §888.3060 Spinal Intervertebral Body Fixation Orthosis Product Codes KWQ. Regulatory Class II. Panel code 87.

# PREDICATE DEVICES:

REVERE™ Stabilization System K061202 (SE July 20, 2006) GATEWAY™ Thoracolumbar Plate System K062407 (SE Sept 6, 2006) Medtronic Sofamor Danek Pyramid Plate K013665 (SE Jan 29,2002) Synthes Anterior Tension Band K022791 (SE Nov 13, 2002) Product code KWQ. Regulatory Class II.

## DEVICE DESCRIPTION:

The CITADEL™ Anterior Lumbar Plate System consists of plates of various lengths with variable or fixed bone screws for spinal fixation of the anterior or anterolateral vertebral bodies of the lumbar or lumbosacral spine (L1-S1). The implants are composed of titanium alloy, as specified in ASTM F136, F1295.

## INTENDED USE:

The CITADEL™ Anterior Lumbar Plate System is intended for use in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

# PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal Systems 510(k)s", May 3, 2004 is presented.

# BASIS OF SUBSTANTIAL EQUIVALENCE:

The CITADEL™ Anterior Lumbar Plate System implants are similar to the predicate devices with respect to technical characteristics, performance, and intended use.

CONFIDENTIAL

GLOBUS MEDICAL

82

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Globus Medical Inc. % Kelly J. Baker, Ph.D Director, Regulatory and Clinical Affairs Valley Forge Business Center 2560 General Armistead Avenue Audubon, Pennsylvania 19403

DEC 1 9 2006

Re: K062836

Trade/Device Name: CITADEL™ Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: November 15, 2006 Received: November 16, 2006

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, EDA over 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. Your 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 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elections 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 logally 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 vours.

Harbare Buchemp

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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### ll. Indications for Use Statement

510(k) Number: K062836

Device Name: CITADEL™ Anterior Lumbar Plate System

# Indications:

The CITADEL™ Anterior Lumbar Plate System is intended for use by an anterior or anterolateral approach in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of fracture (including dislocation and subluxation), turnor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Bouchard

Division Sign-O Division of General, Restorative, and Neurological Devices.

**510(k) Number** K062836

CONFIDENTIAL