MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM

K043181 · Vertebron, Inc. · KWQ · Dec 17, 2004 · Orthopedic

Device Facts

• Record ID: K043181
• Device Name: MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM
• Applicant: Vertebron, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VERTEBRON SCP™ Cervical Plate System is intended for non pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON SCP™ Cervical Plate System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Story

The Vertebron SCP™ Cervical Plate System is a spinal fixation orthosis used by surgeons for anterior stabilization of the cervical spine (C3-C7). The system provides temporary rigid fixation to facilitate fusion in patients with degenerative disc disease, trauma, tumors, or deformity. It is implanted during surgical procedures; the device acts as a mechanical support structure to maintain alignment while bone healing occurs. It benefits patients by stabilizing the spinal column, reducing pain, and promoting successful fusion.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Medical grade titanium conforming to ASTM F136. Spinal intervertebral body fixation orthosis. Mechanical fixation system.

Indications for Use

Indicated for anterior interbody fixation of the cervical spine (C3-C7) in skeletally mature patients for temporary stabilization during fusion. Conditions include degenerative disc disease (discogenic neck pain), trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, and failed previous fusions.

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

• VERTEBRON SCP™ Cervical Plate System (K040003)

Submission Summary (Full Text)

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

## K04318

## DEC 17 2004

## VIII. Summary of Safety and Effectiveness

| SUBMITTER: | VERTEBRON Inc.<br>400 Long Beach Blvd<br>Stratford, CT 06615 |
|------------|--------------------------------------------------------------|
|------------|--------------------------------------------------------------|

CONTACT PERSON: Luis Nesprido

DATE PREPARED: November 11, 2004

CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis

COMMON NAME: Cervical Plating System

PROPRIETARY NAME: VERTEBRON SCP™ Cervical Plate System

PREDICATE DEVICES: VERTEBRON SCP™ Cervical Plate System - K040003

- INTENDED USE: The VERTEBRON SCP™ Cervical Plate System is intended for non pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON SCP™ Cervical Plate System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.
MATERIALS: The material used is medical grade titanium material that conforms to ASTM F136.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with healthcare, with three wavy lines representing the snakes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Mr. Luis Nesprido Vertebron, Inc. 400 Long Beach Boulevard Stratford, Connecticut 06615

Re: K043181

Ro 19101
Trade/Device Name: Vertebron SCPTM Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: November 15, 2004 Received: November 17, 2004

Dear Mr. Nesprido:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt have reviewed your becamed the device is substantially equivalent (for the indications ferenced above and have states to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the enactment date of the Medical Device Amendments, or to conimeres proc to may 20, 2017) in accordance with the provisions of the Federal Food, Drug, de rices that nave been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, diereleve, mains of the Act include requirements for annual registration, listing of general controls province, 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 may or subject to satin adades a 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 r foure oe arrived 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 Errt 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.

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

Page 2 - Mr. Luis Nesprido

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/dsma/dsmamain.html

Sincerely yours,

*C. Colin M. Wittwer, Ph.D., M.D.*

Celia M. Witten.Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## V. Indications for Use

K043181 510(k) Number (if known):

VERTEBRON SCP™ Cervical Plate System Device Name:

Indications For Use:

The VERTEBRON SCP™ Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthriosis, and/or failed previous fusions. The SCP™ Cervical Plate System can be implanted in the sub-axial cervical spine from C3 through C7 levels.

X Prescription Use: (Per 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use: (21 CFR 801 Subpart C)

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milleson

Division of General, Restorative, and Neurological Devices

**510(k) Number** K0431