SPINAL MESH SYSTEM

K011406 · Medtronic Sofamor Danek, Inc. · MQP · Dec 27, 2001 · Orthopedic

Device Facts

• Record ID: K011406
• Device Name: SPINAL MESH SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Dec 27, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medtronic Sofamor Danek SPINAL MESH™ System is for use in the thoracolumbar spine (T1 to L5) to replace and restore the height of a diseased or damaged vertebral body caused by tumor and/or fracture. The SPINAL MESH™ device is intended to be used with supplemental fixation. Allograft or autograft material may be used at the surgeon's discretion.

Device Story

Cylindrically shaped implantable device with hollow core and pyramid-shaped wall openings; designed for vertebral body replacement. Implanted in thoracolumbar spine (T1-L5) by surgeons to restore vertebral height following tumor or fracture. Hollow core and wall openings allow packing with autograft or allograft material to facilitate fusion. Contoured ends grip superior and inferior endplates to provide expulsion resistance. Must be used in conjunction with supplemental spinal fixation systems (e.g., ZPLATE-II, CD HORIZON, TSRH, DYNALOK, Laurain DeWald). Provides structural support to the spinal column; aids in achieving solid fusion.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Cylindrical implant with hollow core and pyramid-shaped wall openings. Materials: Commercially pure titanium or titanium alloy conforming to ASTM F67, ASTM F136, ISO 5832-2, or ISO 5832-3. Mechanical design features contoured ends for endplate gripping and expulsion resistance. Available in various sizes.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to tumor or fracture. Requires use with supplemental spinal fixation systems.

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.

Reference Devices

• ZPLATE-II Anterior Fixation System
• CD HORIZON Spinal System
• TSRH Spinal System
• DYNALOK CLASSIC Spinal System
• Laurain DeWald Anterior Fixation System

Submission Summary (Full Text)

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<011406 p'/2

DEC 2 7 2001

## MEDTRONIC Sofamor Danek SPINAL MESH™ System 510(k) Summary October 2001

| 1. | Company: | Medtronic Sofamor Danek, Inc. |
|----|--------------------------|-------------------------------|
| | 1800 Pyramid Place | |
| | Memphis, Tennessee 38132 | |
| | [phone] | |
| | | |

SPINAL MESH™ System II. Product Name: Classification: MQP

Description: The Medtronic Sofamor Danek SPINAL MESH™ device is a III. cylindrically shaped implantable device with open ends and a hollow core throughout its longitudinal axis. Pyramid shaped openings are built into the wall of the device. These openings and the hollow core allow grafting material to be placed inside the device to help achieve a solid fusion. The contoured ends of the SPINAL MESH™ device serve to grip the superior and inferior end plates, thus allowing expulsion resistance.

The device is made from commercially pure titanium or titanium alloy conforming to such voluntary standards as ASTM F67 and ASTM F136 or the ISO equivalents 5832-2 and 5832-3, and is available in various sizes to match the patients' anatomical requirements.

The SPINAL MESH™ device is intended to be used with supplemental spinal fixation systems that have been labeled for use in the thoracic and/or lumbar spine. These systems include the ZPLATE-IITM Anterior Fixation System, the CD HORIZON® Spinal System, the TSRH® Spinal System, the DYNALOK™ CLASSIC Spinal System, and the Laurain DeWald Anterior Fixation System.

- Indications for Use: The Medtronic Sofamor Danek SPINAL MESH™ System is for IV. use in the thoracolumbar spine (T1 to L5) to replace and restore the height of a diseased or damaged vertebral body caused by tumor and/or fracture. The SPINAL MESH™ device is intended to be used with supplemental fixation. Allograft or autograft material may be used at the surgeon's discretion.

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KU11406e p²/₂

- Substantial Equivalence: The Medtronic Sofamor Danek SPINAL MESH™ System V. was demonstrated to be substantially equivalent to similar previously cleared devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## DEC 2 7 2001

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

Re: K011406

> Trade/Device Name: SPINAL MESH™ System Regulatory Number: 21CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MQP Dated: October 18, 2001 Received: October 19, 2001

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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 510(k) rrail rotification. The FDA finding of substantial equivalence of your device to a premarket nothloade." permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket Also, process note and 1807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
, Mark n Millkuss

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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Page 1 of 1 -October 2001

K611466 510(k) Number (if known): _

SPINAL MESH™ System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

- The Medtronic Sofamor Danek SPINAL MESH™ System is for use in the thoracolumbar spine (T1 to L5) to replace and restore the height of a diseased or damaged vertebral body caused by tumor and/or fracture. The SPINAL MESH™ device is intended to be used with supplemental fixation. Allograft or autograft material may be used at the surgeon's discretion.
(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 (Optional Format 1-2-96)

for Mark N. Millikan

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

KO11406 510(k) Number ________________________________________________________________________________________________________________________________________________________________