CENTERPIECE PLATE FIXATION SYSTEM

K050082 · Medtronic Sofamor Danek, Inc. · NQW · Jun 6, 2005 · Orthopedic

Device Facts

• Record ID: K050082
• Device Name: CENTERPIECE PLATE FIXATION SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: NQW · Orthopedic
• Decision Date: Jun 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.

Device Story

CENTERPIECE™ Plate Fixation System comprises titanium or titanium alloy plates and screws; used in lower cervical and upper thoracic spine (C3-T3) laminoplasty procedures. Device holds graft material in place to prevent expulsion or spinal cord impingement. Operated by surgeons in clinical/OR settings. Output is physical fixation of bone graft. Benefits include stabilization of graft material during spinal surgery.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: medical grade titanium or titanium alloy. Components: plates and screws. Form factor: spinal interlaminal fixation orthosis. Energy source: none (mechanical).

Indications for Use

Indicated for patients undergoing laminoplasty procedures in the lower cervical and upper thoracic spine (C3 to T3) to secure graft material and prevent expulsion or spinal cord impingement.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Kirschner Orthopedic Wire (K850631)

Submission Summary (Full Text)

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| Submitter: | Medtronic Sofamor Danek USA, Inc.<br>1800 Pyramid Place<br>Memphis, TN 38132 |
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| Contact Person: | Richard Treharne<br>[phone] |
| Common Name: | Appliance, Fixation, Interlaminal |
| Trade Name: | CENTERPIECE™ Plate Fixation System |
| Classification: | 21 CFR 888.3050: Spinal interlaminal fixation orthosis.<br>Product Code: NQW |
| Device Description: | The CENTERPIECE™ Plate Fixation System consists of a variety of<br>sizes of plates and screws. The CENTERPIECE™ Plate Fixation<br>System components are made of from medical grade titanium or<br>titanium alloy. |
| Intended Use: | The CENTERPIECE™ Plate Fixation System is intended for use in the<br>lower cervical and upper thoracic spine (C3 to T3) in laminoplasty<br>procedures. The CENTERPIECE™ Plate Fixation System is used to<br>hold the graft material in place in order to prevent the graft material<br>from expulsion, or impinging the spinal cord. |
| Functionality &<br>Safety Testing: | Mechanical testing was performed on the CENTERPIECE™ Plate<br>Fixation System and was included in this submission. |
| Substantial<br>Equivalence | The CENTERPIECE™ Plate Fixation System is substantially<br>equivalent to a previously cleared device used to perform laminoplasty<br>procedures, namely the Kirschner Orthopedic Wire, K850631 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of snakes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 6 - 2005

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

Re: K050082

K050062
Trade/Device Name: CENTERPIECE™ Plate Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: NQW Dated: April 8, 2005 Received: April 11, 2005

Dear Dr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the indication we have reviewed your Section 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) the arrest as a received ate devices marketed in interstate for use stated in the encrosule) to regally manatinent date of the Medical Device Amendments, or to
r commerce prior to May 28, 1976, the enactment date of the Federal Food. commerce prior to May 26, 1776, the enaement and the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premaring of the Act . The and Cosment Act (Act) that do not require approvince to the general controls provisions of the Act. The You may, therefore, market the device, sayest to use ments for annual registration, listing of
general controls provisions of the Act include requirements for and in and general controls provisions of the fiel labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (35c above) into c. Existing major regulations affecting your device . EDA it may oe subject to Such additional controls: "Little 21, Parts 800 to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to anytes can be found in the Could of Peacharies concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuation of a butter complies with other requirements of the Act
that FDA has made a determination that your device complies with other connect that FDA has made a decemmanon that your access by other Federal agencies. You must or any Federal statutes and regulations daminities. but not limited to: registration and listing (21 comply with all the Act Stequirements, measurements as and includes and the sleated CFK Part 807), fabeing (21 CFR Part 807), go a sat 820); and if applicable, the electronic forth in the quality systems (QD) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-

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## Page 2 - Richard W. Treharne, Ph.D.

This letter will allow you to begin marketing your device as described in your Section 510(k) I his icitel will anow you to organ maine of substantial equivalence of your device to a legally premarket notification: "The PDT interestion 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 advice ion your as [phone] . Also, please note the regulation entitled, Contact the Office of Compilance an (21 the Part 807.97). You may obtain Misolanums of reference to premainters within the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or Manufacturers, Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Stypt Awodeu

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _______________CENTERPIECE™ Plate Fixation System

Indications for Use:

The CENTERPIECE™ Plate Fixation System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The CENTERPIECE™ Plate Fixation System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.

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)

Stupt Rlwdn

(Division Sign-Division of Go- and Restorative and Neurologica. Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________