MODIFICATION TO VERTE-STACK SPINAL SYSTEM

K041452 · Medtronic Sofamor Danek · MQP · Jun 24, 2004 · Orthopedic

Device Facts

• Record ID: K041452
• Device Name: MODIFICATION TO VERTE-STACK SPINAL SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: MQP · Orthopedic
• Decision Date: Jun 24, 2004
• 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 construct; requires supplemental anterior/posterior spinal fixation and bone graft. Used by surgeons in clinical settings to restore spinal stability. PEEK or titanium alloy construction allows for modular stacking to match patient-specific anatomical requirements. Titanium constructs are incompatible with stainless steel supplemental fixation. Benefits include stabilization of the spine in patients with trauma or tumor-related vertebral damage.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stackable spacer system; materials: PEEK OPTIMA LT or titanium alloy; includes tantalum markers for radiopacity. Modular design for variable heights. Requires supplemental fixation (stainless steel or titanium for PEEK; titanium only for titanium constructs).

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 (K030736)
• VERTE-STACK™ Spinal System (K030735)
• VERTE-STACK™ Spinal System (K023570)
• VERTE-STACK™ Spinal System (K021791)

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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JUN 2 4 2004

# VERTE-STACK™ Spinal System 510(k) Summary May 2004

K041452
page 1 of 2

- Medtronic Sofamor Danek Company: I. 1800 Pyramid Place Memphis, TN 38132 [phone]
### Proprietary Trade Name: VERTE-STACK™ Spinal System II.

- Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR III. 888.3060)
#### Product Description III.

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 LT) along with a tantalum marker. Alternatively the 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 VERTF-STACK™ constructs may not be used with stainless steel supplemental fixation devices.

The purpose of this submission is to include additional components to the previously cleared VERTE-STACK™ Spinal System.

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#### Indications IV.

K0411452
page 2 of 2

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.

#### Substantial Equivalence V.

Documentation was provided which demonstrated the VERTE-STACK™ Spinal System to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System components found in K030736, K030735, K023570 and K021791.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JUN 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041452

Trade/Device Name: Verte-Stack™ Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 28, 2004 Received: June 01, 2004

Dear Dr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your bector 9 receipe is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the Medical Device Amendments, or to connineree prior to May 20, 1976, the excordance with the provisions of the Federal Food, Drug, de vices that have been require approval of a premarket approval application (PMA). allu Cosmetic Act (11ct) market the device, subject to the general controls provisions of the Act. The r ou may, therefore, mains of the Act include requirements for annual registration, listing of gencial controls provisions or ractice, 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 If your device is elabilition (000 as controls. Existing major regulations affecting your device can may be subject to back access Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Tease of advised that I Drissaanse over device complies with other requirements of the Act that I D7Thas made a aond regulations administered by other Federal agencies. You must of any I caerar statutes and eggirements, including, but not limited to: registration and listing (21 Comply with an the For 816 crockenses, which as a manufacturing practice requirements as set CITY art 6077, adocing (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Section 510(k) This letter will anow you to begin matical equivalence of your device of your device to a legally premarket notincation: The PDF intemsg sification 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 at need 101 ) 594-4692. Also, please note the regulation entitled, contact the Office of Compullier as (SS ) , ; (21CFR 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 responsive in its toll-free number [phone] or Manufacturers, International and Soless http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Melkerson

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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510(k) Number (if known):

Device Name:____VERTE-STACK™ Spinal System

## Indications for Use:

The VERTE-STACK™ Spinal System is a vertebral body replacement device intended for use in the thoracolumbar spine (TI-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, CD HORIZON® Spinal System, the GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

Over-The-Counter Use AND/OR Prescription Use X (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A Milkersan

K04/452
Number