MODIFICATION TO VERTE-STACK SPINAL SYSTEM

K060719 · Medtronic Sofamor Danek · MQP · Apr 14, 2006 · Orthopedic

Device Facts

• Record ID: K060719
• Device Name: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: MQP · Orthopedic
• Decision Date: Apr 14, 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, 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.

Device Story

VERTE-STACK® is a stackable spinal spacer system for vertebral body replacement in the thoracolumbar spine. Components are inserted between vertebral bodies following corpectomy to provide structural support. Device is not a stand-alone system; requires supplemental anterior or posterior spinal instrumentation and bone graft for stability. Surgeons select stackable components of varying sizes/heights to match patient anatomy. Fabricated from PEEK OPTIMA LT1 with titanium or tantalum markers, or entirely from titanium alloy. Titanium constructs are restricted from use with stainless steel supplemental fixation. Device aids in surgical correction and stabilization of the spine.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stackable vertebral body spacer. Materials: PEEK OPTIMA LT1 with titanium/tantalum markers or titanium alloy. Form factor: modular, stackable components of varying sizes/heights. 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) resulting from 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 (K041556)
• VERTE-STACK® Spinal System (K043561)
• 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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K060719

## VERTE-STACK® Spinal System 510(k) Summary March 2009PR 1 4 2006

APR 14 2006

| I. | |
|----------|-------------------------|
| Company: | Medtronic Sofamor Danek |
| | 1800 Pyramid Place |
| | Memphis, TN 38132 |
| | [phone] |

Contact: Edward S. Chin Group Director Regulatory and Clinical Affairs

II. Proprietary Trade Name: VERTE-STACK® Spinal System

- Classification Name/Product Code: Spinal Intervertebral Body Fixation Orthosis (21 III. CFR 888.3060)
- IV. Product Code: MOP

## V. Product Description

The VERTE-STACK® device is a stackable spacer, which inserts between vertebral bodies in the anterior thoracic and lumbar spine. The device is intended for vertebral body replacement to aid in the surgical correction and stabilization of the spine. The construct is not intended to be employed as a stand-alone device. The VERTE-STACK® device is fabricated and manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT1) along with either titanium or tantalum markers. Alternatively the entire device may be manufactured from titanium alloy.

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 must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured with PEEK may be used with stainless steel or titanium supplemental fixation devices. Titanium VERTE-STACK® constructs may not be used with stainless steel supplemental fixation devices.

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The purpose of this submission is to include slightly modified components to the previously cleared VERTE-STACK® Spinal System.

## Indications VI.

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.

## VII. Substantial Equivalence

Documentation was provided which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to components previously cleared in VERTE-STACK® Spinal System 510(k) applications K041556, (SF07/01/04), K043561, (SE 12/27/04), K052931, (SE 11/16/05) and K030736 (SE 04/02/03).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2006

Medtronic Sofamor Danek c/o Mr. Edward S. Chin Group Director, Clinical and Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

Re: K060719

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: MOP Dated: March 16, 2006 Received: March 17, 2006

Dear Mr. Chin:

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 coomers co 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 Cosmelic Act (Act) that do not require approval of a premarket approval application (PMA). You costi. therefore, market the device, subject to the general controls provisions of the Act. To general controls provisions of the Act include requirements for annual registration, listing of devines a 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 devine can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA mev 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. Edward S. Chin

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,

Hickenlooper

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):

K060719

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 (TI-LS) 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, 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)

Hellen Lemus Co

Division of General, Restorative, and Neurological Devices

**510(k) Number** k060719