VERTE-STACK SPINAL SYSTEM

K031780 · Medtronic Sofamor Danek · MQP · Jul 30, 2003 · Orthopedic

Device Facts

Record IDK031780
Device NameVERTE-STACK SPINAL SYSTEM
ApplicantMedtronic Sofamor Danek
Product CodeMQP · Orthopedic
Decision DateJul 30, 2003
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3060
Device ClassClass 2
AttributesTherapeutic

Intended Use

The VERTE-STACKTM 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, Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System, the Titanium GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK™ device is intended to be used with bone graft.

Device Story

VERTE-STACK™ is a stackable PEEK spacer system for anterior thoracic and lumbar vertebral body replacement. Components are available in various sizes/heights to accommodate individual patient anatomy following corpectomy. Device is not for stand-alone use; requires supplemental anterior/posterior spinal instrumentation and bone graft for stability. Used by surgeons in clinical settings to restore spinal column height and provide stabilization. Benefits include structural support for damaged or unstable vertebral bodies.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and material characteristics.

Technological Characteristics

Materials: Polyetheretherketone (PEEK OPTIMA LT) per ASTM F2026; Tantalum markers per ASTM F-560. Design: Stackable spacer components of varying sizes/heights. 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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ # JUL 3 0 2003 KO31780 ## VERTE-STACK™ Spinal System 510(k) Summary June 2003 - Medtronic Sofamor Danek I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133 #### 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 PEEK 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) as described by ASTM F2026. The tantalum marker used for this product is made to the voluntary standard of ASTM F-560. 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 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. The purpose of this submission is to add modified components to the VERTE-STACK™ Spinal System. #### IV. 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™ {1}------------------------------------------------ K031786 Page 2 of 2 device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, the Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System, the Titanium GDLH® Spinal System 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 (K023570, SE 11/19/02 and K021791, SE 08/26/02). {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 3 0 2003 Richard W. Treharne, Ph.D. Sr. Vice President Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 Re: K031780 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: MOP Dated: June 27, 2003 Received: June 30, 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 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. {3}------------------------------------------------ Page 2 - Richard W. 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Alvah A. Millican 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 {4}------------------------------------------------ K031780 510(k) Number (if known): Device Name: VERTE-STACK™ Spinal System Indications for Use: The VERTE-STACKTM 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, Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System, the Titanium GDLH® Spinal System, or their successors. Additionally, the VERTE-STACK™ 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 Milkross Restorative 510(k) Number
Innolitics
510(k) Summary
Decision Summary
Classification Order
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