The VERTE-STACKTM 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 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 POLYETHERETHERKETONE (PEEK OPTIMA LT) along with a tantalum marker. Alternatively the device may be manufactured from titanium alloy.

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 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 include additional components to the previously cleared VERTE-STACK™ Spinal System.

AI/ML Overview

This 510(k) summary (K041556) describes a conventional spinal implant system, the VERTE-STACK™ Spinal System. For this type of device, performance is typically assessed through substantial equivalence to predicate devices, mechanical testing, and biocompatibility, rather than clinical studies involving human readers or AI.

Therefore, the following information regarding acceptance criteria, study details, and expert involvement for AI/human reader performance studies is not applicable to this submission. The device's acceptance is based on its similarity to previously cleared devices (predicates) and its ability to meet established material and mechanical standards.

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

Acceptance Criteria	Reported Device Performance
Material Composition	Based on Polyetheretherketone (PEEK OPTIMA LT) with a tantalum marker OR Titanium alloy.
Indications for Use (Substantial Equivalence)	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 (i.e., fracture).
Use with Supplemental Fixation	To be used with additional anterior and/or posterior spinal instrumentation to augment stability (e.g., Medtronic Sofamor Danek ZPLATE II Anterior Fixation System, DYNALOK™ CLASSIC Spinal System, VANTAGE™ Anterior Fixation System, TSRH® System, CD HORIZON® Spinal System, GDLH® Spinal System, and/or their successors); PEEK constructs with stainless steel or titanium fixation; Titanium constructs NOT with stainless steel fixation.
Use with Bone Graft	Intended to be used with bone graft.
Design Characteristics	Stackable components of different sizes and heights to suit individual patient pathology and anatomical requirements. May be used individually or stacked.
Substantial Equivalence to Predicate Devices	Demonstrated substantial equivalence to previously cleared VERTE-STACK™ Spinal System components (K031780 and K040536).

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

Not applicable. This device's clearance relied on substantial equivalence and non-clinical testing, not a test set of patient data for performance evaluation in the context of AI or human reading.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth for clinical interpretation or AI performance was not established as part of this submission. The "ground truth" for this device relates to its material properties, mechanical integrity, and design features conforming to established standards for spinal implants.

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

Not applicable. No test set requiring expert adjudication for clinical evaluations was mentioned in the provided text.

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 device is a physical surgical implant, not a diagnostic or AI-assisted interpretation tool. Therefore, MRMC studies are not relevant.

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

Not applicable. This is a medical device (spinal implant), not an algorithm or AI.

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

The "ground truth" implicitly referred to for this type of device includes:

Engineering consensus and established industry standards for material strength, biocompatibility, and mechanical properties.
Regulatory definitions and requirements for spinal intervertebral body fixation orthoses.
Data supporting the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this device's evaluation is not based on machine learning.

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

Not applicable. No training set was used.

Summary

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K041556,

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VERTE-STACK™ Spinal System 510(k) Summary June 2004

JUL 01 2004

I. Company:	Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 (901) 396-3133
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Contact: Richard W. Treharne, PhD Sr. Vice President Regulatory Affairs

Proprietary Trade Name: VERTE-STACKTM 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 purpose of this submission is to include additional components to the previously cleared VERTE-STACK™ Spinal System.

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K04156, Pg 2/2

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 DYNALOK™ CLASSIC Spinal System, the VANTAGE™ Anterior Fixation System, the TSRH® 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.

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 components found in K031780 and K040536.

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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 & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized symbol that resembles an eagle or a bird in flight, with three curved lines representing its wings and body. The overall design is simple and professional, reflecting the department's role in public health and human services.

Public Health Service

JUL 01 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041556

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: MQP Dated: June 4, 2004 Received: June 10, 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, 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" (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,

Miriam C. Provost

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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K041556

510(k) Number (if known):

Device Name: VERTE-STACK™ Spinal System

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)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_K 64155p

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.