When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks
The occipitocervical plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors
The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

Device Description

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.

The VERTEX® Reconstruction System is fabricated from medical grade titanium, medical grade titanium alloy, and medical grade cobalt chromium. Medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium alloy, and or/cobalt chromium with stainless steel in the same construct. The VERTEX® Reconstruction System includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium, titanium alloy, and cobalt chromium implants only. Some components contain elastomeric stakes made of silicone adhesive commonly used in implantable medical devices. Do not use with stainless steel.

To achieve best results, do not use any of the VERTEX Reconstruction System implant components with components from any other system or manufacturer unless specifically labeled to do so in this or another MEDTRONIC document. As with all orthopedic and neurosurgical. implants, none of the VERTEX Reconstruction System components should ever be reused under any circumstances.

AI/ML Overview

The presented document is a 510(k) summary for the VERTEX® Reconstruction System, a spinal fixation device. This type of document is a premarket notification for a medical device submitted to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The 510(k) summary focuses on demonstrating "substantial equivalence" rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be seen for AI/ML-driven devices.

Therefore, many of the requested criteria for AI/ML device studies are not applicable to this document. The study described is primarily a mechanical testing comparison to predicate devices.

Here's an breakdown of the information that can be extracted and what is not applicable:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Substantial equivalence to predicate devices (K003780, K042789, K052376, K053483 for VERTEX® systems, and K014296 for CD HORIZON® Spinal System).	"Documentation was provided demonstrating that the VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System in K003780 (S.E. 9/28/01), K042789 (S.E. 12/21/04), K052376 (S.E. 9/26/05), and K053483 (S.E. 1/15/06) and in CD HORIZON® Spinal System K014296 (S.E. 12/10/02)."
Mechanical testing results of subject device components comparing to predicate device components.	"The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components."

Acceptance Criteria

Reported Device Performance

Substantial equivalence to predicate devices (K003780, K042789, K052376, K053483 for VERTEX® systems, and K014296 for CD HORIZON® Spinal System).

"Documentation was provided demonstrating that the VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System in K003780 (S.E. 9/28/01), K042789 (S.E. 12/21/04), K052376 (S.E. 9/26/05), and K053483 (S.E. 1/15/06) and in CD HORIZON® Spinal System K014296 (S.E. 12/10/02)."

Mechanical testing results of subject device components comparing to predicate device components.

"The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components."

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 document describes mechanical testing for substantial equivalence, not a clinical study or an AI/ML model's test set on human data. The "sample size" would refer to the number of components tested mechanically, which is not specified in this summary.
Data provenance: Not specified, as it's mechanical test data, not patient data.

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 AI/ML models or clinical diagnostic studies is not relevant here. The "ground truth" for mechanical testing would be established by engineering standards and validated testing protocols, not expert consensus on medical images or patient outcomes.

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

Not applicable: Adjudication methods are used in clinical studies or AI/ML model evaluations where there might be disagreement in expert interpretation. This is not how mechanical testing is assessed.

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 surgical implant system, not an AI-assisted diagnostic tool or a system that involves "human readers." No MRMC study was conducted.

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

Not applicable: This device is a physical surgical implant. There is no algorithm or standalone performance in the context of AI/ML.

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

For mechanical testing: The "ground truth" is defined by established engineering and biomechanical standards for spinal implant performance, typically involving load-to-failure, fatigue testing, and other mechanical property assessments. It's not a clinical "ground truth" like pathology or outcomes.
For substantial equivalence: The "ground truth" is the performance and characteristics of the predicate devices.

8. The sample size for the training set

Not applicable: This involves mechanical testing for substantial equivalence, not an AI/ML model with a training set.

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

Not applicable: See above. There is no "training set" in the context of this 510(k) submission.

Summary

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Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and a letter. The sequence starts with the letter 'K', followed by the numbers '090714'. The numbers are written in a slightly irregular style, but they are still legible.

VERTEX® Reconstruction System 510(k) Summary

March 2009

Sr. Regulatory Affairs Specialist

I. Company:	Medtronic Sofamor Danek USA1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact:	Melisa Lansky, M.B.A.

II. Proposed Proprietary Trade Name: VERTEX® Reconstruction System
III. Classification Name(s): Spinal Interlaminal Fixation Orthosis; Class: II; Product Code(s): K WP and Regulation No.: 888.3050
IV. Description: The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-axial screws, and connecting components, which can be rigidly locked to the rod in a variety of configurations, with each construct being tailor-made for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion. See the package inserts of both of those systems for labeling limitations.

V. Indications for Use:

page 1 of 2

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K090714

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks The occipitocervical plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors

The use of multi-axial screws is limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

VI. Substantial Equivalence: Documentation was provided demonstrating that the VERTEX® Reconstruction System is substantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System in K003780 (S.E. 9/28/01), K042789 (S.E. 12/21/04), K052376 (S.E. 9/26/05), and K053483 (S.E. 1/15/06) and in CD HORIZON® Spinal System K014296 (S.E. 12/10/02). The results of mechanical testing performed for the subject VERTEX® Reconstruction System components were equivalent to the testing performed for the predicate VERTEX® Reconstruction System components.
C 2009 Medtronic Sofamor Danek

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek, USA % Ms. Melisa Lanksy, M.B.A Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

APR 1 7 2009

Re: K090714

Trade/Device Name: VERTEX® Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP Dated: March 17, 2009 Received: March 18, 2009

Dear Ms. Lanksy:

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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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- Ms. Melisa Lanksy, M.B.A

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Barbare buend

Mark N. Melke Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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2090714

510(k) Number (if known):

Device Name: VERTEX® Reconstruction System

Indications for Use:

When intended as an adjunct to fusion of the occipitocervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft for the following:

Occipitocervical Components: Plate Rod/Plates/Rods/Occipital Screws/Hooks

The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

Multi-axial Screws/Connectors

The use of multi-axial screws are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Prescription Use (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)

baularo Varehuntofa, mkn

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

510(k) Number
page 1 of 1 K090714

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.