MODIFICATION TO VERTE-STACK SPINAL SYSTEM

K052931 · Medtronic Sofamor Danek · MQP · Nov 16, 2005 · Orthopedic

Device Facts

• Record ID: K052931
• Device Name: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: MQP · Orthopedic
• Decision Date: Nov 16, 2005
• 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 (T1-L5). Components are inserted between vertebral bodies following corpectomy to provide structural support; used to treat collapse, damage, or instability from tumor or trauma. Device is not stand-alone; requires supplemental anterior/posterior fixation systems (e.g., ZPLATE II, CD HORIZON) and bone graft. Components are stackable to accommodate individual patient anatomy. Operated by surgeons in a clinical/OR setting. Benefits include spinal stabilization and correction. Constructed from PEEK OPTIMA LT1 with titanium/tantalum markers or solid titanium alloy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stackable spacer system; materials: PEEK OPTIMA LT1 with titanium or tantalum markers, or titanium alloy. Designed for anterior thoracic/lumbar placement. Non-standalone; requires supplemental fixation. Titanium constructs incompatible with stainless steel fixation. 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 (K041197)
• 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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# VERTE-STACK® Spinal System 510(k) Summary October 2005

| Company: | Medtronic Sofamor Danek<br>1800 Pyramid Place<br>Memphis, TN 38132<br>[phone] |
|----------|--------------------------------------------------------------------------------------|
| Contact: | Richard W. Treharne |

Richard W. Treharne Contact: Sr. Vice President Regulatory Affairs

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

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

#### 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 POLYETHERETONE (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.

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

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K052931 Page 2 of - 2

#### 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 was provided which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to the previously cleared VERTE-STACK® Spinal System (K041197, SE 08/09/04 and K030736, SE 04/02/03).

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized image of three human figures, represented by flowing lines, suggesting a sense of movement and connection.

NOV 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052931

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: October 14, 2005 Received: October 19, 2005

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, 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 W. Treharne

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin finding of substantial equivalence of your device to a legally prematication: "The PDA maing of casification 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 If you desire specific adviser 3 at [phone]. Also, please note the regulation entitled, and "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 other general information on your responses Assistance at its toll-free number [phone] or Manufacturers, International and Octess http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C. Mark N. Murray

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K052931 510(k) Number (if known):

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.

AND/OR

Prescription Use X (Part 21 CFR 801 Subpart D) 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)

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

510/k) Number KOS29S