VERTE-STACK SPINAL SYSTEM

K061938 · Medtronic Sofamor Danek, Inc. · MQP · Aug 9, 2006 · Orthopedic

Device Facts

• Record ID: K061938
• Device Name: VERTE-STACK SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Aug 9, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VERTE-STACK® 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-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, the CD HORIZON® Spinal System, the GDLH® Spinal System and/or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

Device Story

VERTE-STACK® is a vertebral body replacement system consisting of stackable, hemi-cylindrical center and add-on cages of varying lengths, diameters, and angulations. Designed for surgical implantation in the thoracolumbar spine (T1-L5) to replace damaged or unstable vertebral bodies. Components are assembled into constructs tailored to individual patient anatomy. System requires use with supplemental anterior/posterior spinal fixation and bone graft. PEEK-OPTIMA LT1 or titanium alloy construction with tantalum/titanium markers. Used by surgeons to restore spinal column integrity following corpectomy. Benefits include structural support for the vertebral space.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: PEEK-OPTIMA LT1, titanium alloy, tantalum/titanium markers. Form factor: Hemi-cylindrical stackable cages. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to collapsed, damaged, or unstable vertebral bodies caused by 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-STACK® Spinal System (K060719)
• VERTE-STACK® Spinal System (K052931)
• VERTE-STACK® Spinal System (K030736)

Reference Devices

• ZPLATE II Anterior Fixation System
• DYNALOK™ CLASSIC Spinal System
• VANTAGE™ Anterior Fixation System
• TSRH® Spinal System
• CD HORIZON® Spinal System
• GDLH® Spinal System

Submission Summary (Full Text)

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K061938
Page 1 of 2

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# VERTE-STACK® Spinal System 510(k) Summary July 2006

AUG - 9 2006

- Medtronic Sofamor Danek I. Company: 1800 Pyramid Place Memphis, TN 38132 [phone]
## Lee Grant Contact: Supervisor, Regulatory Affairs

- Proprietary Trade Name: VERTE-STACK® Spinal System II.
- · III. Classification Name/Product Code: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060)
- IV. Product Code: MQP

### Product Description V.

The VERTE-STACK® device consists of hemi-cylindrical center cages of various lengths and diameters, as well as hemi-cylindrical add on cages of various lengths, diameters and angulation. The assembled VERTE-STACK® device consists of three components (one hollow center cage, and two hollow add-on cages). The VERTE-STACK® components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

The design of the VERTE-STACK® device includes a variety of stackable components of different sizes and heights. The stackable components are designed to suit the individual patient pathology.

The VERTE-STACK® device may be used individually, or two or more may be stacked together in order to accommodate the individual anatomical requirements of the vertebral space created by the corpectomy.

The VERTE-STACK® Spinal System implant components are made of medical grade PEEK-OPTIMA LT1 along with a marker made from either Tantalum or titanium. Alternatively, VERTE-STACK® Spinal System may be manufactured from titanium allov.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured from PEEK may be used with stainless steel or titanium supplemental

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fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission was to add slightly modified centerpieces to the existing VERTE-STACK® Spinal System.

#### V. Indications

The VERTE-STACK® 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-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® Spinal System, the CD HORIZON® Spinal System, the GDLH® Spinal System and/or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

#### VI. Substantial Equivalence

Documentation, including mechanical test results, was provided which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to the previously cleared VERTE-STACK® Spinal System (K060719, SE 4/12/2006; K052931, SE 11/13/2005; and K030736, SE 4/2/2003).

KOGIG 39

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) in the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and human needs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2006

Medtronic Sofamor Danek c/o Mr. Lee Grant Supervisor, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

Re: K061938

Trade/Device Name: VERTE-STACK® Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: July 6, 2006 Received: July 10, 2006

Dear Mr. Grant:

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, 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 - Mr. Lee Grant

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" (21 CFR 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/industry/support/index.html.

Sincerely yours,

Bailaya Buehup

Mark N. Melkerson 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): 0601938

VERTE-STACK® Spinal System Device Name:_

## Indications for Use:

The VERTE-STACK® 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 turnor or trauma (i.e., fracture). The VERTE-STACK® Spinal System is to be used with supplemental fixation. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, TSRH® Spinal System, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK® device is intended to be used with bone graft.

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)

Barbere Michand Rixm

Division of General, Restorative. and Neurological Devices

**510(k) Number** K061938