VANTAGE ANTERIOR FIXATION SYSTEM

K031533 · Medtronic Sofamor Danek, Inc. · KWP · Jun 13, 2003 · Orthopedic

Device Facts

• Record ID: K031533
• Device Name: VANTAGE ANTERIOR FIXATION SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jun 13, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Properly used, the VANTAGE™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.

Device Story

VANTAGE™ Anterior Fixation System is a spinal orthosis consisting of plates, screws, nuts, spacers, and staples. Device provides mechanical stabilization of the spine to facilitate solid fusion. Components are configured and locked by surgeons during spinal procedures. System is used in clinical settings for patients with degenerative disc disease, deformities, fractures, or tumors. Output is a rigid construct providing structural support to the spinal column. Benefits include stabilization of unstable segments and correction of deformities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Spinal intervertebral body fixation orthosis; components include plates, screws, nuts, spacers, and staples; mechanical fixation system; non-powered; manual surgical instrumentation.

Indications for Use

Indicated for patients requiring spinal stabilization during fusion for degenerative disc disease, pseudoarthrosis, spondylolysis, spinal deformity (kyphosis/lordosis), fracture, failed prior surgery, tumor resection, neoplastic disease, or deformity from deficient posterior elements (laminectomy, spina bifida, myelomeningocele).

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.

Submission Summary (Full Text)

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**JUN 13 2003**

## VANTAGE™ Anterior Fixation System 510(k) Summary May 2003

- Medtronic Sofamor Danek I. Company: 1800 Pyramid Place Memphis, TN 38132 [phone]
#### Proprietary Trade Name: VANTAGE™ Anterior Fixation System II.

Regulation Number and Product Code: 888.3050 - KWP III.

#### IV. Product Description

The VANTAGE™ Anterior Fixation System consists of a variety of shapes and sizes of plates, screws, nuts, spacers and staples, as well as ancillary products and instrument sets. The components can be locked into a variety of configurations, with each construct tailor-made for the individual case.

The purpose of this submission is to add bolts to the VANTAGE™ Anterior Fixation System.

#### V. Indications

Properly used, the VANTAGE™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.

#### VI. Substantial Equivalence

Documentation was provided which demonstrated the VANTAGE™ Anterior Fixation System to be substantially equivalent to itself.

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird design with three profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top of the logo.

JUN 1 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K031533

Trade Name: VANTAGE™ Anterior Fixation System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWP Dated: May 15, 2003 Received: May 16, 2003

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

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.

Mark McMillan

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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# 510(k) Number (if known):_KO3 1533

### Device Name: VANTAGE™ Anterior Fixation System

### Indications for Use:

Properly used, the VANTAGE™ Anterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4) spinal deformation such as kyphosis and lordosis, (5) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability and/or deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic disease, and/or (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.

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

Concurrence of CDRH, Office of Evaluation (ODE)

(Per 21 CFR 801.109) (Optional 1-2-96)

OR

Over-the-counter Use __

03/533

Mark N Millerson

feneral. Restorative

510(k) Number_

500032