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`Paige l 4+1
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`JUL 3 0 2003
`
`VERTE-STACKT” Spinal System
`510(k) Summary
`June 2003
`
`I.
`
`Company:
`
`Medtronic Sofamor Danek
`
`1800 Pyramid Place
`Memphis, TN 38132
`(901) 396-3133
`
`II.
`
`III.
`
`III.
`
`Proprietary Trade Name: VERTE-STACKT“ Spinal System
`
`Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR
`888.3060)
`
`Product Description
`
`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 ofthe Spine’.
`
`The construct is not intended to be employed as a stand-alone device. The VERTE-
`
`STACKTM 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 ofthe VERTE-STACKTM 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-STACKT“ 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—S'I'ACKT”
`
`Spinal System.
`
`IV.
`
`Indications
`
`The VERTE-STACKTM Spinal System is a vertebral body replacement device intended
`
`for use in the thoracolumbar spine (Tl—L5) to replace a collapsed, damaged, or unstable
`
`vertebral body due to tumor or trauma (i.e., fracture). The VERTE-STACKTM Spinal
`
`System is to be used with supplemental fixation. Specifically, the VERTE-STACKT“
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`device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation
`System, the Titanium DYNALOKT“ CLASSIC Spinal System, the VANTAGET“
`
`Anterior Fixation System, the Titanium TSRH® Spinal System, the Titanium CD
`
`HORIZON® Spinal System, the Titanium GDLH® Spinal System or their successors.
`
`Additionally, the VERTBSTACKT“ device is intended to be used with bone graft.
`
`V.
`
`Substantial Equivalence
`
`Documentation was provided which demonstrated the VERTBSTACKT“ Spinal System
`
`to be substantially equivalent to the previouslycleared VERTE-STACK‘*“ Spinal System
`
`(KO23570, SE l 1/19/02 and K02l79l, SE 08/26/02).
`
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`DEPARTMENTOFHEALTH8:.HUMANSERVICES
`
`PublicHealthService
`
`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: VERTESTACKW Spinal System
`Regulation Number: 21 CFR 888.3060
`Regulation Name: Spinal intervertebral body fixation orthosis
`Regulatory Class:
`11
`Product Code: MQP
`Dated: June 27, 2003
`
`Received: June 30, 2003
`
`Dear Dr. Treharne:
`
`We have reviewed yourSection 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 ofthe Act); 21 CFR 1000- l 050.
`
`

`
`Page 2 ~ Richard W. Trehame, 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 ofyour 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 htt ://www.fda. ov/cdrh/dsma/dsmamain.html
`
`Sincerely yours,
`
`all atails/-
`% 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
`
`

`
`510(k) Number (ifknown):
`
`K 03 H50
`
`Device Name:
`
`VERTE-STACK“ Spinal SQ/stem
`
`Indications for Use:
`
`June 2003
`
`P39‘ I “r ‘
`
`The VERTBSTACK”‘ Spinal System is a vertebral body replacement device intended for use in the
`
`thoracolumbar spine (Tl-LS) to replace a collapsed, damaged, or unstable vertebral body due to tumor or
`
`trauma (i.e., fracture). The VERTBSTACKTM Spinal System is to be used with supplemental fixation.
`
`Specifically, the VERTE-STACKT“ device is to be used with the Medtronic Sofamor Danek ZPLATE ll
`
`Anterior Fixation System, Titanium DYNALOK7“ CLASSIC Spinal System, the VANTAGET” Anterior
`
`Fixation System, Titanium TSRH® Spinal System, Titanium CD HORIZON® Spinal System, the Titanium
`
`GDLH® Spinal System, or their successors. Additionally, the VERTE-STACKT“ device is intended to be
`
`used with bone graft.
`
`(PLEASE DO NOT VVRITE BELOW THIS LINHONTINUE ON ANOTHER PAGE IF NEEDED)
`
`Concurrence OFCDRH, Office of Evaluation (ODE)
`
`Prescription Use
`(Per 21 CFR 801.109)
`
`I
`
`OR
`
`Over-The-Counter Use
`
`(Optional 1-2-96)
`
` (Division Sign—Ofi)
`
`Division of General. Restorative
`and Neurological Devices
`
`510(k) Number
`
`
`
`)<o5/780
`
`000158