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, 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 F-1579. 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 mav be used individually. or two or more mav 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.

The purpose of this submission is to include additional sizes to the VERTE-STACK™ Spinal System.

AI/ML Overview

This 510(k) premarket notification for the VERTE-STACK™ Spinal System describes a device that is substantially equivalent to previously cleared devices. Therefore, it does not present new acceptance criteria or a study demonstrating device performance against new criteria. Instead, the submission relies on the established equivalence to predicate devices.

Here's a breakdown of the requested information based on the provided text, indicating where information is not applicable or not provided for an equivalence submission:

Acceptance Criteria and Study for VERTE-STACK™ Spinal System (K030601)

This submission (K030601) is a 510(k) premarket notification claiming substantial equivalence to previously cleared VERTE-STACK™ Spinal System devices (K023570 and K021791). In such an application, the primary "acceptance criterion" is generally demonstrating that the new device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness, compared to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (as demonstrated by equivalence to predicates)
Intended Use: Replace collapsed, damaged, or unstable vertebral body due to tumor or trauma in T1-L5 with supplemental fixation and bone graft.	The VERTE-STACK™ Spinal System (K030601) has the same indications for use as the predicate VERTE-STACK™ Spinal Systems (K023570 and K021791).
Technological Characteristics: PEEK spacer, stackable, used with specified spinal instrumentation and bone graft.	The VERTE-STACK™ Spinal System (K030601) is fundamentally the same design as the predicate, made from PEEK OPTIMA LT and Tantalum markers. The submission's purpose is to include additional sizes, implying similar manufacturing processes and materials, and thus similar performance to the existing line.
Material Biocompatibility: PEEK OPTIMA LT (ASTM F-1579) and Tantalum (ASTM F-560).	The device is fabricated from PEEK OPTIMA LT (ASTM F-1579) and uses Tantalum markers (ASTM F-560), identical to or consistent with materials likely used in the predicate devices, which are accepted standards.
Mechanical Performance/Structural Integrity: Ability to withstand loads in the anterior thoracic and lumbar spine when used with supplemental fixation.	Not explicitly detailed in this document, but substantial equivalence implies that the mechanical properties of the new sizes are consistent with the safety and effectiveness of the previously cleared predicate devices. Typically, mechanical testing (e.g., compression, torsion, bending) demonstrating compliance with relevant ASTM or ISO standards would have been performed for the original predicate devices. The addition of new sizes would likely involve demonstrating that these new sizes also meet the same mechanical performance expectations.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable / Not provided. This is a substantial equivalence claim based on the device's design, materials, and intended use being similar to existing cleared devices. It does not involve a clinical study with a distinct "test set" of patients or data in the way an AI/software device would. The "test" is the comparison to the predicate device and relevant standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable / Not provided. Given that this is a product submission for a physical medical device (spinal implant) based on substantial equivalence, there is no "ground truth" derived from expert interpretation of data in the manner of an AI diagnostic device. The "ground truth" is typically established by engineering design, material specifications, and performance testing against recognized standards.

4. Adjudication Method for the Test Set

Not applicable / Not provided. As there is no "test set" in the context of expert review for diagnostic accuracy, no adjudication method is relevant here.

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. This submission is for a physical spinal implant, not an AI or software-as-a-medical-device (SaMD). Therefore, no MRMC study or AI assistance evaluation was performed.

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

Not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

Engineering Specifications and Standard Compliance: The "ground truth" for this type of device relies on established engineering principles, material specifications (e.g., ASTM F-1579 for PEEK, ASTM F-560 for Tantalum), and a demonstration that the device's design and intended performance are safe and effective, typically through mechanical testing and validation of material properties. For a substantial equivalence claim, the primary "ground truth" is the previously cleared predicate devices and the accepted safety and effectiveness established for them.

8. The Sample Size for the Training Set

Not applicable / Not provided. This is not an AI/ML device where a training set size would be relevant. The "training" for such a device is in its design, manufacturing processes, and adherence to quality systems.

9. How the Ground Truth for the Training Set was Established

Not applicable / Not provided. There is no "training set" in the context of an AI/ML workflow. For a physical device, the "ground truth" for its design and manufacturing is established through adherence to recognized standards, quality control, and pre-clinical testing that establishes its safety and performance characteristics.

Summary

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K030601 P1/2

MAR 2 5 2003 VERTE-STACK™ Spinal System 510(k) Summary Februarv 2003

Medtronic Sofamor Danek I. Company: 1800 Pvramid Place Memphis, TN 38132 (901) 396-3133
Proprietarv Trade Name: VERTE-STACK™ Spinal System II.

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 pathology.

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 include additional sizes to the VERTE-STACK™ Spinal System.

IV. Indications

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|K030601 $\rho^{2/2}$

COUNT

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.

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 (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 features a stylized eagle with three heads, representing the department's commitment to health, human services, and the USA. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2003

Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis. Tennessee 38132

Re: K030601

Trade/Device Name: VERTE-STACK™ Spinal System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MQP Dated: February 24, 2003 Received: February 25, 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. Iisting 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) 594-4639. 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,

Mark McKinnon

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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510(k) Number (if known):

K030601

VERTE-STACK™ Spinal System 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, 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.

(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. Mulkeran

(Division Sign-Off) General, Rest prative and Neurological Devices 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.