MODIFICATION TO VERTE-STACK SPINAL SYSTEM

K043561 · Medtronic Sofamor Danek · MQP · Dec 29, 2004 · Orthopedic

Device Facts

Record IDK043561
Device NameMODIFICATION TO VERTE-STACK SPINAL SYSTEM
ApplicantMedtronic Sofamor Danek
Product CodeMQP · Orthopedic
Decision DateDec 29, 2004
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 888.3060
Device ClassClass 2
AttributesTherapeutic

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 Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. 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 aid surgical correction and stabilization. Device is not for stand-alone use; requires supplemental anterior/posterior spinal instrumentation and bone graft. Fabricated from titanium alloy or PEEK OPTIMA LT with tantalum markers. Stackable design allows customization to individual patient anatomy. Used by surgeons in clinical settings to restore vertebral height and provide structural support in cases of tumor or trauma.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stackable spacer system; materials: titanium alloy or PEEK OPTIMA LT; includes tantalum markers for radiopacity. Modular design for height adjustment. Must be used with supplemental fixation (e.g., ZPLATE II, DYNALOK, VANTAGE, TSRH, CD HORIZON, GDLH). Titanium constructs incompatible with stainless steel fixation.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ DEC 2 9 2004 ### VERTE-STACK™ Spinal System 510(k) Summary December 2004 - I. Medtronic Sofamor Danek Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133 | Contact: | Richard W. Treharne, PhD<br>Sr. Vice President Regulatory Affairs | |----------|-------------------------------------------------------------------| |----------|-------------------------------------------------------------------| II. Proprietary Trade Name: VERTE-STACK™ Spinal System ### III. Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) #### III. 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 titanium alloy. Alternatively the device may be manufactured from POLYETHERETHERKETONE (PEEK OPTIMA LT) and includes a tantalum marker. 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 anatomy. 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 offer a titanium version of the previously cleared VERTE-STACK™ Spinal System components. 000050 Page 1 of 2 {1}------------------------------------------------ #### 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™ 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 or the Titanium GDLH® Spinal System. Additionally, the VERTE-STACK™ device is intended to be used with bone graft. #### V. Substantial Equivalence 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 K041556 and K040422. # 000051 Page 2 of 2 {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a caduceus, a symbol often associated with healthcare, featuring a staff with a snake winding around it. DEC 2 9 2004 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Richard W. Treharne, PhD Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132 Re: K043561 Trade/Device Name: Medtronic Sofamor Danek VERTRE-STACK 110 Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 22, 2004 Received: December 27, 2004 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, PhD 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 (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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. Sincerely yours, Mark McMullen 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}------------------------------------------------ ## KOY 5261 Page 1 of _ 1 December 2004 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 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 Titanium DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD HORIZON® Spinal System or the Titanium GDLH® Spinal System. 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) 1043561 Mark A Milken Division of General, Restorative, and Neurological Devices 513(k) Number 000103 Page 1 of 1
Innolitics
510(k) Summary
Decision Summary
Classification Order
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