ORIA ZENITH

K030500 · Ortho Tec, LLC · KWQ · Mar 20, 2003 · Orthopedic

Device Facts

• Record ID: K030500
• Device Name: ORIA ZENITH
• Applicant: Ortho Tec, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 20, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORIA ZENITH is intended for anterior screw fixation of the cervical spine and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include failed previous fusion, pseudarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies. WARNING: The ORIA ZENITH is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Device Story

ORIA ZENITH is a cervical plate system; provides stabilization as adjunct to spinal fusion. Components include titanium alloy plates and screws (fixed/variable, self-tapping options). Used by surgeons in clinical settings for anterior cervical spine fixation. Device provides mechanical support to spinal segments; aids fusion process. Benefits patients by stabilizing spine in cases of trauma, deformity, or degenerative disease.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy (ASTM F136) construction; anterior cervical plate and screw system; fixed and variable screw options (4.0mm and 4.5mm diameters); self-tapping screw variants available.

Indications for Use

Indicated for anterior cervical spine screw fixation as an adjunct to spinal fusion in patients with failed previous fusion, pseudarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis, or degenerative disc disease (neck pain of discogenic origin confirmed by history/radiography). Contraindicated for posterior element (pedicle) fixation in cervical, thoracic, or lumbar spine.

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.

Submission Summary (Full Text)

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## 510(k) SUMMARY

Sponsor:
Eurosurgical, SA
B.P.23-18 rue Robespierre
Beaurains, France 62217
Phone: [phone], Fax: [phone]

Contact
Person:
Emmanuel Margerit, Regulatory Affairs and Quality Manager

Proprietary
Trade Name:
ORIA ZENITH

Device
Description:
The ORIA ZENITH is a cervical plate system consisting of plates and screws
manufactured from titanium alloy (ASTM F 136). Plates are available in a
variety of lengths. Fixed and variable screws are available in a variety of lengths
and diameters of 4.0 and 4.5mm. A self-tapping version of each screw is also
available.

Intended Use:
The ORIA ZENITH is intended for anterior screw fixation of the cervical spine
and is designed to provide stabilization as an adjunct to spinal fusion at these
levels. Indications for the use of this device include failed previous fusion,
pseudarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis or
degenerative disc disease defined as neck pain of discogenic origin with the
degeneration of the disc confirmed by history and radiographic studies.

WARNING: The ORIA ZENITH is *not* intended for screw attachment or
fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar
spine.

Materials:
The ORIA ZENITH is manufactured from titanium alloy (ASTM F136).

Substantial
Equivalence:
Documentation was provided which demonstrated the ORIA ZENITH to be
substantially equivalent to a previously cleared device. The substantial
equivalence is based upon equivalence in indications/intended use,
manufacturing methods, attachment mechanism, basic design and materials.

MAR 2 0 2003

MAR 20 2003

KAZOSO
page 1 of

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, with human profiles incorporated into the design of the eagle's body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 0 2003

Eurosurgical, SA c/o Ms. Karen E. Warden, MEBE VP Regulatory Affairs & Research REO Spine Line 7000 Hampton Center, Suite G1 Morgantown, West Virginia 26505

Re: K030500

> Trade Name: ORIA ZENITH Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: February 18, 2003 Received: February 19, 2003

Dear Ms. Warden:

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

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Page 2 - Ms. Karen E. Warden, MEBE

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. 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,

Mark N. Mulberson

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

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## Indications for Use Statement

K030500 510(k) Number (if known):

Page 1 of 1

Device Name: ORIA ZENITH

Indications for Use:

The ORIA ZENTH is intended for anterior screw fixation of the cervical spine and is designed to provide stabilization as an adjunct to spinal fusion at these levels. Indications for the use of this device include failed previous fusion, pseudarthrosis, tumor, deformity, spinal stenosis, trauma, spondylolisthesis or degenerative disc disease defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

WARNING: The ORIA ZENITH is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Mark N. Melluson

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

510(k) Number K030500

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-the-Counter Use