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.

Device 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 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.

AI/ML Overview

The provided document is a 510(k) summary for the VERTE-STACK™ Spinal System. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and performance study results as if for a novel device. Therefore, much of the requested information (e.g., specific performance metrics, sample sizes for test/training sets, expert qualifications) is not available in this type of submission.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Devices	The VERTE-STACK™ Spinal System was found to be substantially equivalent to the previously cleared VERTE-STACK™ Spinal System (K023570 and K021791).
Intended Use	The device is intended for vertebral body replacement in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (fracture).
Material Composition	Fabricated from POLYETHERETHERKETONE (PEEK OPTIMA LT) as described by ASTM F2026. The tantalum marker is made to ASTM F-560.
Design	Stackable PEEK spacer, available in various sizes and heights to suit individual patient pathology. Can be used individually or stacked.
Compatibility with Supplemental Fixation	Must be used with additional anterior and/or posterior spinal instrumentation from specific Medtronic Sofamor Danek systems (e.g., ZPLATE II, DYNALOK™ CLASSIC, VANTAGE™, TSRH®, CD HORIZON®, GDLH®).
Use with Bone Graft	Intended to be used with bone graft.

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This 510(k) summary primarily addresses substantial equivalence based on design, materials, and indications for use compared to predicate devices, rather than clinical performance data from a specific test set. There is no mention of a test set being used to evaluate performance against specific acceptance criteria.

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

Not applicable/Not provided. The concept of "ground truth" established by experts for a test set is not relevant for this type of 510(k) submission, which focuses on device design and equivalence.

4. Adjudication method for the test set

Not applicable/Not provided. No test set or adjudication method is described in this submission.

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

Not applicable/Not provided. This device is a physical spinal implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not relevant.

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

Not applicable/Not provided. This is a physical medical device, not an algorithm.

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

Not applicable/Not provided. The "ground truth" in this context would implicitly refer to the established safety and effectiveness of the predicate devices based on their prior clearances and clinical experience. The submission relies on the concept of "substantial equivalence" to these known, safe, and effective devices.

8. The sample size for the training set

Not applicable/Not provided. This is not a machine learning device, so the concept of a "training set" is not relevant.

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

Not applicable/Not provided. As above, no training set is relevant.

Summary

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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 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™

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K031786

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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).

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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.

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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

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K031780

510(k) Number (if known):

Device Name: VERTE-STACK™ Spinal System

Indications for Use:

(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

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.