ORION ANTERIOR CERVICAL PLATING SYSTEM

K042235 · Medtronic Sofamor Danek · KWQ · Sep 17, 2004 · Orthopedic

Device Facts

• Record ID: K042235
• Device Name: ORION ANTERIOR CERVICAL PLATING SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWQ · Orthopedic
• Decision Date: Sep 17, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with patients with at generation of patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Device Story

ORION® Anterior Cervical Plate System consists of titanium alloy plates, pre-assembled set screws, washers, and associated instruments. Device used by surgeons via anterior approach to provide temporary fixation to cervical vertebral bodies during spinal fusion. System stabilizes spine in patients with degenerative disc disease, trauma, tumors, deformity, or pseudarthrosis. Output is mechanical stabilization of the cervical spine. No software or electronic components involved.

Clinical Evidence

No clinical data. Substantial equivalence supported by risk analysis and bench-level comparison data.

Technological Characteristics

Materials: Titanium alloy. Components: Plates, pre-assembled set screws, washers, and instruments. Energy source: None (mechanical). Sterilization: Supplied sterile or non-sterile. Design: Anterior cervical plate system for interbody fixation.

Indications for Use

Indicated for temporary stabilization of the anterior cervical spine during fusion in patients with degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, or failed previous fusions. Contraindicated for screw attachment to posterior elements (pedicles) of the 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.

Predicate Devices

• ORION® Anterior Cervical Plate System (K973854)

Submission Summary (Full Text)

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## ORION® Anterior Cervical Plate System Special 510(k) Summary - K042235 September 2004

| I. | Company: | Medtronic Sofamor Danek USA<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>[phone] |
|-----|--------------------------------------------------|-------------------------------------------------------------------------------------------------|
| | Contact: | Richard Treharne<br>Sr. Vice President Regulatory Affairs |
| II. | Product Name: | ORION® Anterior Cervical Plate System |
| | Classification Name:<br>Classification No./Code: | Spinal intervertebral body fixation orthosis<br>888.3060 - KWO |

- The ORION® Anterior Cervical Plate System consists of a variety of shapes and sizes of bone III. plates (set screws and washers are pre-assembled to plates), screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy and may be supplied either sterile or non-sterile. The purpose of this 510(k) is to include modified screws to the ORION® Anterior Cervical Plate System.
- IV. The ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions 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), pseudarthrosis, and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

- The subject ORION® Anterior Cervical Plate System screws were claimed to be substantially V. equivalent to the predicate ORION® Anterior Cervical Plate System screws cleared in K973854 (SE 3/16/98). A risk analysis and comparison data were provided in support of this notification.
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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/2 description: The image shows the 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 three overlapping wing-like shapes.

SEP 1 7 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard W. Treharne, PhD. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K042235

Trade/Device Name: ORION® Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: August 17, 2004 Received: August 18, 2004

Dear Dr. Treharne:

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 for associated in 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, do noos mat have 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 11 Jour av 100 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 - Richard W. Treharne, PhD.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begin mainer of substantial equivalence of your device to a legally premarket notification: The PDF intelligsting 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 If you desire specific acrioliance at [phone]. Also, please note the regulation entitled, Connact the Office of Companies and (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,

Miriam C. Provost

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

Enclosure

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## August 2004

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510(k) Number (if known): _ hoy 2235

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

The ORION® Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with patients with at generation of patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

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

510(k) Number_Koya 235

000085

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