VERTEBRON SCP CERVICAL PLATE SYSTEM

K040003 · Vertebron, Inc. · KWQ · Mar 26, 2004 · Orthopedic

Device Facts

• Record ID: K040003
• Device Name: VERTEBRON SCP CERVICAL PLATE SYSTEM
• Applicant: Vertebron, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 the C3 through C7 levels.

Device Story

Vertebron SCP™ Cervical Plate System consists of implantable titanium alloy plates and screws; includes manual surgical instruments for implantation. Used by surgeons in clinical settings to provide temporary stabilization of anterior cervical spine during fusion procedures. Device supports bone healing by maintaining alignment; benefits patient by stabilizing spine segments affected by disease, trauma, or deformity. Supplied non-sterile; requires hospital-based sterilization prior to use.

Clinical Evidence

Bench testing only. Device tested in accordance with ASTM F1717 requirements; results demonstrate performance comparable to predicate cervical plate systems.

Technological Characteristics

Materials: Titanium alloy per ASTM F136-98. Components: Metal plates and screws. Form factor: Anterior cervical plate system. Sterilization: Non-sterile, intended for hospital-based sterilization. No software or electronic components.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization during fusion. Conditions include degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, and failed previous fusions. Applicable to sub-axial cervical spine levels C3-C7.

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

• Centerpulse Spine-Tech (K022344)
• Theken Surgical (K010466)
• Blackstone Medical (K030595)

Submission Summary (Full Text)

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MAR 2 6 2004

VERTEBRON. Inc. 510(k) Notilitation

## K040003

## 510(k) SUMMARY OF SAFETY & EFFECTIVENESS

| SUBMITTER | Vertebron, Ltd.<br>Stratford, CT 06614 |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON | Bruce Khalili<br>Vice President, Research & Development |
| DATE PREPARED | December 23, 2003 |
| CLASSIFICATION | Spinal Interlaminal Fixation Orthosis; KWQ<br>Class II |
| COMMON NAME | Anterior Cervical Plate |
| PROPRIETARY NAME | Vertebron SCP™ Cervical Plate System |
| PREDICATE DEVICES | Centerpulse Spine-Tech K022344<br>Theken Surgical K010466<br>Blackstone Medical K030595 |
| DEVICE DESCRIPTION | The device consists of a system of implantable metal plates<br>and screws intended the purpose of aiding in spinal fusion.<br>The system also includes various hand tool used to assist in<br>implantation of the system. Implantable components are<br>composed of titanium alloy meeting the requirements of<br>ASTM F136-98. The device is supplied non-sterile and is<br>intended for sterilization by hospital personnel. |
| TESTING | The device has been tested in accordance with the<br>requirements prescribed in ASTM F1717. The device was<br>found to perform comparably to other cervical plate systems. |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

MAR 2 6 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Bruce Khalili Vice President, Research & Development Vertebron, Inc. 136 Albert Avenue Stratford, Connecticut 06614

Re: K040003

Trade/Device Name: Vertebron SCP™ Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: December 30, 2003 Received: January 2, 2004

Dear Mr. Khalili:

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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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 vours.

Sincerely yours,

Mark N. Millican

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

Enclosure

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## STATEMENT FOR INDICATIONS FOR USE

510(k) Number:

Device Name: Vertebron SCP™ Cervical Plate System

## 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 the C3 through C7 levels.

Prescription Use: Yes

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

Concurrence of CDRH, Office

/ Mark H. Milhusan
(Division Engineer)

Vertebran SCPM C 510(K