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 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 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 VERTE-STACK™ constructs may not be used with stainless steel supplemental fixation devices.

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

AI/ML Overview

This document is a 510(k) summary for the VERTE-STACK™ Spinal System. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting de novo clinical study results against predefined acceptance criteria.

Therefore, I cannot answer your request based on the provided text. The document does not include:

A table of acceptance criteria and reported device performance.
Sample size used for a test set or data provenance.
Number of experts or their qualifications for ground truth establishment.
Adjudication method for a test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
Information about a standalone algorithm performance study.
The type of ground truth used.
The sample size for a training set.
How the ground truth for a training set was established.

The core of this document is to establish substantial equivalence for modifications to an existing device, as stated in section V: "Documentation was provided which demonstrated the VERTE-STACK™ Spinal System to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System (K030736, SE 04/02/03)."

Summary

{0}------------------------------------------------

AUG - 9 2004

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

Medtronic Sofamor Danek Company: I. 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 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 purpose of this submission is to include modified versions of the previously cleared VERTE-STACK™ Spinal System components.

{1}------------------------------------------------

$$
\xi \circ \iota \eta \llcorner \xi \cdot \iota \qquad \qquad \xi \circ \iota \circ \iota
$$

Indications IV.

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, 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 (K030736, SE 04/02/03).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2004

Richard W. Treharne, Ph.D. Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K041197

Korrer >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: July 27, 2004 Received: July 28, 2004

Dear Dr. Treharne:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) primation is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for the stated in the encrosure) to regally manetone for the Medical Device Amendments, or to comments provided to May 28, 1776, the encordance with the provisions of the Federal Food, Drug, devices that have been rechasined in assere approval of a premarket approval application (PMA). and Cosmetic Act (110) that do novice, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the act include requirements for annual registration, listing of gencial controls provisions of the rest 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 classified (600 a0070) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation E Inay be subject to sam additions. Title 21, Parts 800 to 898. In addition, FDA may be found in the Our enterning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease of advised that I Dri-Staantes of wor device complies with other requirements of the Act that I DA has made a doter.mialations administered by other Federal agencies. You must of any Federal statutes and regulations to comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with an the Act 31equirements, n.c., good manufacturing practice requirements as set CFR Part 807); adomig (DT CFR Part 820); and if applicable, the electronic form in the quality by sions (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) I his letter will anow you to ocgin makemig your antial equivalence of your device to a legally premarket nothcation - The FDA midning of backland of 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 advice for your act 100 mease note the regulation entitled, the comments of Contact the Office of Complanes at (501) ->>< < 1 807.97). You may obtain Misoranumig by reference to premail.orgibilities under the Act from the Division of Small other general information on your responsibility of the mumber (800) 638-2041 or
Manufacturers, International and Consumer Assistance at its toll-ifree in trade Manufacturers, International and Ochess http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milam
Celia M. Witten, Ph.D., M.D.

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}------------------------------------------------

KO41197 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 (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, 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.

(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 A. Wilkerson

al. Restorative, Division of Gener and Neurologica! Devices

510(k) Number K041197

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
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.(b)
Classification. Class II.