VERTE-SPAN SPINAL SYSTEM

K024049 · Medtronic Sofamor Danek, Inc. · MQP · Feb 26, 2003 · Orthopedic

Device Facts

• Record ID: K024049
• Device Name: VERTE-SPAN SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Feb 26, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VERTE-SPAN™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-SPAN™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-SPAN™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, LAURAIN DEWALD Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. Additionally, the VERTE-SPAN™ device is intended to be used with bone graft.

Device Story

VERTE-SPAN™ is a vertebral body replacement system consisting of titanium alloy cylinders, endplates, and break-off set screws. The device is assembled into a custom configuration for each patient to replace damaged or unstable vertebral bodies in the thoracolumbar spine. It is used in conjunction with supplemental anterior or posterior spinal fixation systems (e.g., ZPLATE II, DYNALOK, TSRH, CD HORIZON, GDLH) and bone graft to provide structural support and stability. The device is implanted by a surgeon in a clinical/surgical setting. The rigid, tailor-made construct provides mechanical support to the spine, facilitating stabilization and potentially improving patient outcomes following vertebral body loss due to trauma or tumor.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Medical grade titanium alloy (Ti-6Al-4V) per ASTM F136 or ISO 5832-3. Components: Hollow metal cylinders, endplates, and break-off set screws. Configuration: Modular, tailor-made constructs. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with collapsed, damaged, or unstable vertebral bodies in the thoracolumbar spine (T1-L5) due to tumor or trauma (fracture). Must be used with supplemental fixation and bone graft.

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

• VERTE-SPAN™ Spinal System (K010930)

Submission Summary (Full Text)

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# VERTE-SPAN™ Spinal System 510(k) Summary December 2002

FEB 2 6 2003

- I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 [phone]
II. Proprietary Trade Name: VERTE-SPAN™ Spinal System Regulation Number: 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Product code: MOP, KWO

#### Product Description III.

The VERTE-SPAN™ device consists of titanium cylinders of various lengths and diameters, endplates and break-off set screws. The assembled VERTE-SPAN™ device consists of five components (one hollow metal cylinder, two endplates and two set screws). The VERTE-SPAN™ components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. The VERTE-SPAN™ Spinal System implant components are made of medical grade titanium alloy (Ti-6A1-4V) described by ASTM Standard F136 or ISO 5832-3.

The purpose of this submission is to add components to the existing system and to incorporate some minor design changes.

The VERTE-SPAN™ Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability

#### IV. Indications

The VERTE-SPAN" Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-SPAN™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-SPAN™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, LAURAIN DEWALD Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. Additionally, the VERTE-SPANTM device is intended to be used with bone graft.

#### V. Substantial Equivalence

Documentation was provided which demonstrated the VERTE-SPAN™ Spinal System to be substantially equivalent itself the VERTE-SPAN™ Spinal System K010930 (SE 10/24/01).

. 6329

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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 & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Public Health Service

FEB 2 6 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K024049 Re:

> Trade Name: VERTE-SPAN™ Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: January 30, 2003 Received: January 31, 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 conirols 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 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 - Dr. Richard 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 yours,

L. Mark N. Milkman

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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December 2002

### KO24049 510(k) Number (if known):

Device Name: VERTE-SPAN™ Spinal System

## Indications for Use:

The VERTE-SPANTM Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The VERTE-SPAN™ Spinal System is to be used with supplemental fixation. Specifically, the VERTE-SPAN™ device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, Titanium DYNALOK™ CLASSIC Spinal System, LAURAIN DEWALD Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. Additionally, the VERTE-SPAN™ device is intended to be used with bone graft.

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

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional 1-2-96)

Mark N Milhem

estorative ()(k) Number

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