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 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 alloy.

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 modify the geometry of the implants and to include additional sizes into the existing VERTE-STACK® Spinal System.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the VERTE-STACK® Spinal System, a medical device for vertebral body replacement. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than a study proving the device meets specific acceptance criteria through clinical or performance measures against a defined ground truth.

This submission is for a modification to the geometry and additional sizes of an existing device, relying on mechanical test results to show substantial equivalence to predicate devices (K060719 and K052931). Therefore, the concept of "acceptance criteria" for clinical performance, ground truth, expert adjudication, multi-reader multi-case studies, or standalone algorithm performance, as typically understood in AI/imaging device submissions, is not directly applicable here.

Instead, the "acceptance criteria" are implied by the regulatory standard for 510(k) clearance: demonstration of substantial equivalence to a legally marketed predicate device.

Given the nature of this document, much of the requested information does not apply. Here's a breakdown based on the provided text:

Acceptance Criteria and Study Details for VERTE-STACK® Spinal System (K062073)

The acceptance criteria for this 510(k) submission are not expressed as specific performance metrics (e.g., sensitivity, specificity) but rather as the demonstration of "substantial equivalence" to predicate devices. This is achieved through mechanical testing and comparison of design features.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by 510(k) process)	Reported Device Performance (Summary from submission)
Mechanical Equivalence: The modified device's mechanical properties (e.g., strength, stability) are comparable to the predicate devices.	"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; and K052931, SE 11/13/2005)."
Material Equivalence: The materials used are equivalent or acceptable for the intended use and consistent with predicate devices.	"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 alloy." (This implies a comparison and acceptance of these materials relative to the predicate.)
Indications for Use Equivalence: The intended use of the modified device is the same as the predicate devices.	The Indications for Use section is identical to indications likely associated with the predicate devices. (Not explicitly stated as "equivalent" but presented as existing indications).
Design Integrity: Modifications (geometry, additional sizes) do not negatively impact safety or effectiveness compared to predicate.	"The purpose of this submission was to modify the geometry of the implants and to include additional sizes into the existing VERTE-STACK® Spinal System." (The approval indicates these changes were acceptable and did not compromise equivalence).
Compatibility: The device maintains compatibility with specified supplemental fixation systems.	"The VERTE-STACK® Spinal System must be used with additional anterior and/or posterior spinal instrumentation to augment stability. Specifically, the VERTE-STACK® device is to be used with the Medtronic Sofamor Danek ZPLATE II Anterior Fixation System... and/or their successors." (Compatibility is implicitly accepted if substantial equivalence is granted).

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

Test Set Sample Size: Not applicable in the context of data for AI/imaging. The "test set" in this case refers to the modified device components and their mechanical testing. The document does not specify the number of components or test specimens.
Data Provenance: The study described is mechanical testing performed by the manufacturer, Medtronic Sofamor Danek. No information is provided regarding the country of origin of this data, but it would typically be conducted in controlled laboratory environments. The study is akin to a prospective engineering validation of the new design, rather than retrospective analysis of clinical data.

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

Number of Experts: Not applicable. Ground truth, in the sense of expert consensus on diagnosis or interpretation, is not established for this type of mechanical device submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no clinical imaging test set requiring adjudication in this submission. The "adjudication" is essentially the FDA's regulatory review of the provided mechanical test data and comparison to predicate devices, performed by agency experts.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This is a submission for a mechanical implant, not an AI or imaging diagnostic device where human reader performance is assessed.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Standalone Study: Not applicable. This device is a mechanical implant, not an algorithm. The "standalone" performance refers to the device's mechanical integrity as demonstrated by testing, which is its inherent function without a "human-in-the-loop" interpretative aspect.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this submission is based on engineering standards, material specifications, and benchmark mechanical performance data established for the predicate devices. The mechanical test results for the new device were compared against these established specifications to demonstrate equivalence.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/machine learning submission; therefore, there is no "training set."

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

Ground Truth for Training Set: Not applicable.

Summary

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

K062073 p
pg 1/2

I. Company: Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
AUG 1 4 2006

Contact: Lee Grant Supervisor, Regulatory Affairs

II. Proprietary Trade Name: VERTE-STACK® Spinal System
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 modify the geometry of the implants and to include additional sizes into the existing VERTE-STACK® Spinal System.

V. Indications

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; and K052931, SE 11/13/2005).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2006

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

Re: K062073

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 19, 2006 Received: July 21, 2006

Dear Mr. Grant:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf have reviewed your becament be device is substantially equivalent (for the indications ferenced above and havesure) to legally marketed predicate devices marketed in interstate for use stated in the entrebule 776, the enactment date of the Medical Device Amendments, or to conniner of they 2011-11-11 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). and Cosmetic Hor (110) that the device, subject to the general controls provisions of the Act. The r ou may, aterere, mains 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 rt your de rise ts exactives (controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, and 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 r least be has made a determination that your device complies with other requirements of the Act that I Dr Hazal statutes and regulations administered by other Federal agencies. You must or any I 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 Of It Far 8077, lavemig (2 (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. This

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Page 2 - Mr. Lee Grant

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 (24 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 Maco facturers, 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,

Barbara Buehm

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):

062072

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, 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.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C) ?
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchup

Division of General, Restorative. and Neurological Devices

510(k) Number K062073

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.