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 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.

AI/ML Overview

The provided text is a 510(k) summary for the VERTE-STACK™ Spinal System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than for proving the acceptance criteria of a novel device through a clinical study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not applicable or not present in this document.

Here's an analysis of the available information:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. 510(k) summaries for spinal implants typically focus on demonstrating mechanical and material equivalence to existing devices, along with similar indications for use. They do not usually include acceptance criteria and performance data in the way a clinical trial for a diagnostic device or a new therapeutic device might.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

This information is not provided as there is no specific "test set" or clinical study described in terms of patient data. The submission relies on establishing substantial equivalence to previously cleared devices (K041556 and K040422).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. As there's no clinical test set for diagnostic performance, ground truth establishment by experts is not applicable here.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided as there is no clinical test set with an adjudication process described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable and not provided. This device is a spinal implant, not an AI-powered diagnostic or assistive tool, so an MRMC study is irrelevant to its approval.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This information is not applicable and not provided. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not applicable and not provided. For a spinal implant 510(k), "ground truth" in the clinical sense of diagnostic accuracy is not the primary focus. The "truth" in this context revolves around demonstrating the material properties, mechanical performance, and biomechanical equivalence to predicate devices, often through bench testing and engineering analysis rather than human ground truth.

8. The sample size for the training set:

This information is not provided. The concept of a "training set" is typically associated with machine learning or AI algorithm development, which is not relevant to this medical device submission.

9. How the ground truth for the training set was established:

This information is not applicable and not provided for the same reasons as in point 8.

Summary of what the document does indicate:

The submission focuses on demonstrating substantial equivalence of a titanium version of the VERTE-STACK™ Spinal System to previously cleared VERTE-STACK™ Spinal System components (K041556 and K040422). This means that the device is considered safe and effective because it is similar to devices already on the market. The basis for approval is that the new titanium version shares similar design, materials (with the exception of the specific titanium versus PEEK), intended use, and performance characteristics with the predicate devices. The document highlights:

Product Description: A stackable spacer for vertebral body replacement in the anterior thoracic and lumbar spine, made from titanium alloy (previously PEEK OPTIMA LT was also an option).
Intended Use: Thoracolumbar spine (T1-L5) to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma, always used with supplemental fixation and bone graft.
Substantial Equivalence: Documentation was provided demonstrating equivalence to K041556 and K040422. This is the "study" alluded to, but it's a comparison to predicates, not a clinical trial with acceptance criteria for device performance in patients.

In essence, this 510(k) summary is not a report of a clinical study designed to meet specific performance acceptance criteria for a novel device, but rather a regulatory filing asserting similarity to existing approved devices.

Summary

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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, PhDSr. Vice President Regulatory Affairs
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II. Proprietary Trade Name: VERTE-STACK™ Spinal System

III. Classification Name: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060)

III. Product Description

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 purpose of this submission is to offer a titanium version of the previously cleared VERTE-STACK™ Spinal System components.

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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.

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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.

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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

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KOY 5261

Page 1 of _ 1 December 2004

510(k) Number (if known):

Device Name:

Indications for Use

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

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.