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 turnor 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.

Device Description

The VERTE-STACK® device consists of hemi-cylindrical center cages of various lengths and diameters, as well as hemi-cylindrical add on cages of various lengths, diameters and angulation. The assembled VERTE-STACK® device consists of three components (one hollow center cage, and two hollow add-on cages). The VERTE-STACK® components can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

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 implant components are made of medical grade PEEK-OPTIMA LT1 along with a marker made from either Tantalum or titanium. Alternatively, VERTE-STACK® Spinal System may be manufactured from titanium allov.

The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. VERTE-STACK® constructs manufactured from 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 was to add slightly modified centerpieces to the existing VERTE-STACK® Spinal System.

AI/ML Overview

This document describes the VERTE-STACK® Spinal System, a medical device designed for vertebral body replacement. The key information for this submission is that it's a 510(k) premarket notification for modifications to an existing device, specifically the addition of "slightly modified centerpieces" to the already cleared VERTE-STACK® Spinal System.

Due to the nature of this submission being an update/modification to an already cleared device through a 510(k) pathway, the "study" proving it meets acceptance criteria is typically a demonstration of substantial equivalence to the predicate device, not necessarily a de novo clinical trial with human subjects.

Here's a breakdown based on your request, as much as can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Equivalence to legally marketed predicate devices (K060719, K052931, K030736). This implies meeting the same mechanical strength, durability, and functional requirements.	Documentation, including mechanical test results, was provided which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to the previously cleared VERTE-STACK® Spinal System.

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

Sample Size for Test Set: This information is not explicitly provided in the document. Mechanical testing typically involves a set number of components tested for various parameters (e.g., compression, torsion, fatigue) according to recognized standards. The document only mentions "mechanical test results."
Data Provenance: The data provenance is from Medtronic Sofamor Danek's internal testing. It is not specified if any external labs were used. The document does not indicate country of origin of the data beyond the company's location (Memphis, TN, USA). It is a prospective test in the sense that new components were manufactured and tested according to a protocol.

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

Ground Truth for Test Set: The "ground truth" in this context is the mechanical performance standards and specifications that the predicate devices meet. These are established through recognized industry standards (e.g., ASTM, ISO for medical implants) and regulatory requirements for spinal implants.
Experts and Qualifications: The document does not specify the number or qualifications of experts involved in establishing these mechanical standards. These would typically be biomedical engineers, materials scientists, and regulatory experts. The FDA's review process (implied by the 510(k) clearance) involves regulatory and engineering experts who evaluate the submitted test data against these established standards.

4. Adjudication Method for the Test Set

Adjudication Method: For mechanical testing, adjudication typically involves comparison of the test results against predefined acceptance criteria/specifications. If the results fall within the acceptable range and demonstrate equivalence to the predicate, it is considered successful. There is no "adjudication method" in the sense of multiple human readers independently assessing medical images; rather, it's objective measurement comparison.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases. The VERTE-STACK® Spinal System is an implantable surgical device, and its clearance relies on mechanical and material equivalence rather than diagnostic performance assessed by human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This is also not applicable to an implantable surgical device.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth used is primarily objective mechanical performance specifications and regulatory standards for spinal intervertebral body fixation orthoses. The demonstration is that the modified device's mechanical properties align with those of previously cleared, substantially equivalent devices. This is not pathology, outcomes data, or expert consensus on a clinical outcome for this type of submission.

8. The Sample Size for the Training Set

Sample Size for Training Set: This concept is not applicable to the VERTE-STACK® Spinal System submission. "Training set" refers to data used to train an AI algorithm. This device is a physical implant, not an AI or diagnostic software.

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

Ground Truth for Training Set Establishment: This concept is not applicable as there is no AI algorithm training set involved in this submission.

Summary

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K061938
Page 1 of 2

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VERTE-STACK® Spinal System 510(k) Summary July 2006

AUG - 9 2006

Medtronic Sofamor Danek I. Company: 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133

Lee Grant Contact: Supervisor, Regulatory Affairs

Proprietary Trade Name: VERTE-STACK® Spinal System II.
· III. Classification Name/Product Code: Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060)
- IV. Product Code: MQP

Product Description V.

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.

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

The purpose of this submission was to add slightly modified centerpieces to the existing VERTE-STACK® Spinal System.

V. 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 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.

VI. Substantial Equivalence

Documentation, including mechanical test results, was provided which demonstrated that the subject VERTE-STACK® Spinal System components are substantially equivalent to the previously cleared VERTE-STACK® Spinal System (K060719, SE 4/12/2006; K052931, SE 11/13/2005; and K030736, SE 4/2/2003).

KOGIG 39

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) in the United States. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and human needs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 9 2006

Medtronic Sofamor Danek c/o Mr. Lee Grant Supervisor, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

Re: K061938

Trade/Device Name: VERTE-STACK® Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MQP Dated: July 6, 2006 Received: July 10, 2006

Dear Mr. Grant:

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 - Mr. Lee Grant

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" (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Bailaya Buehup

Mark N. Melkerson 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): 0601938

VERTE-STACK® Spinal System 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)

Barbere Michand Rixm

Division of General, Restorative. and Neurological Devices

510(k) Number K061938

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.