When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated 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 Plate/Rod/Occipital Screws/Hooks
The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), 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.
The use of the occipitocervical plate/rod requires 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 (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

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

Device Description

The VERTEX® Reconstruction System is a posterior system, which consists of a variety of shapes and sizes of 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 tailormade for the individual case. Titanium ATLAS® cable may be used with this system at the surgeon's discretion.
The VERTEX® Reconstruction System is fabricated from medical grade titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Never use stainless steel and titanium implant components in the same construct.

AI/ML Overview

The VERTEX® Reconstruction System is a medical device and its "performance" is based on mechanical testing demonstrating substantial equivalence to predicate devices, rather than clinical performance metrics typically associated with AI/software devices. Therefore, many of the requested categories are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This device is not a software or AI-driven system; its "performance" is demonstrated through mechanical testing to show substantial equivalence to already marketed devices. There are no specific acceptance criteria percentages (e.g., sensitivity, specificity) for device performance in this 510(k) summary, as it's a hardware device.

Acceptance Criteria (General)	Reported Device Performance
Mechanical Equivalence to Predicate Devices	Demonstrated mechanical equivalence to five legally marketed occipito-cervico-thoracic fixation devices.
Material Compatibility	Fabricated from medical grade titanium alloy; retaining ring from Shape Memory Alloy (Nitinol - NiTi) compatible with titanium/titanium alloy. No use with stainless steel.
Intended Use	Expanded to include occiput and additional components.
Indications for Use (Specific)	Spinal fusion for occipitocervical, cervical, and thoracic spine (Occiput-T3) for conditions like DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed fusion, and tumors.
Constraint on Screw Placement	Occipital screws limited to occipital fixation only (not cervical spine). Multi-axial screws limited to T1-T3 (not cervical spine).

2. Sample Size for Test Set and Data Provenance

Not applicable. This device's clearance is based on mechanical testing (benchtop) rather than a clinical "test set" of patient data. Therefore, there's no data provenance in terms of country of origin or retrospective/prospective nature.

3. Number of Experts for Ground Truth and Qualifications

Not applicable. Ground truth for a hardware device in mechanical testing is typically defined by engineering specifications and objective measurements, not expert consensus.

4. Adjudication Method

Not applicable. There's no adjudication method mentioned as it's not a clinical study involving human assessment of device outcomes or image interpretation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a hardware device submission, not an AI/software device that would involve human readers. Therefore, no MRMC study was performed, and there is no effect size of human readers improving with AI assistance.

6. Standalone Performance Study

In a sense, the mechanical testing is a "standalone" performance evaluation of the device components themselves, independent of human interaction in a diagnostic or interpretive capacity. However, it's not "standalone (i.e. algorithm only without human-in-the loop performance)" as understood in AI contexts. The testing determines if the components meet strength, fatigue, and other biomechanical criteria comparable to predicate devices.

7. Type of Ground Truth Used

For the mechanical testing, the "ground truth" would be engineering specifications, biomechanical standards, and comparative data from predicate devices. This involves objective measurements of strength, durability, and other physical properties.

8. Sample Size for Training Set

Not applicable. This is not a machine learning or AI device that requires a training set of data.

9. How Ground Truth for Training Set was Established

Not applicable. No training set was used.

Summary

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VERTEX® Reconstruction System 510(k) Summary - K052402 September 2005

I. Company:	Medtronic Sofamor Danek USA, Inc.
	1800 Pyramid Place
	Memphis, Tennessee 38132
Contact:	Richard W. Treharne
	Sr. Vice President Regulatory Affairs
	(901) 396-3133
II. Product Name:	VERTEX® Reconstruction System
Classification Name:	Spinal Interlaminal Fixation Orthosis
	Pedicle Screw Spinal System
Regulation Number:	888.3050, 888.3070
Code:	KWP, MNI

III. Description:

The VERTEX® Reconstruction System is fabricated from medical grade titanium alloy. The VERTEX® Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel. Never use stainless steel and titanium implant components in the same construct.

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 allowed to do so in this or another Medtronic Sofamor Danek document. As with all orthopedic and neurosurgical implants, none of the VERTEX® Reconstruction System components should ever be reused under any circumstances.

The purpose of this submission was to expand the levels of use to include the occiput and to include additional components in the system ..

Page 1 of 2

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IV Indications

Occipitocervical Plate/Rod/Occipital Screws/Hooks

The occipitocervical plate/rods, occipital screws (3.5mm, 4.0mm and 4.5mm cancellous), 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.

The use of the occipitocervical plate/rod requires 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 (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

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

V. Substantial Equivalence:

Mechanical testing was provided demonstrating that the VERTEX® Reconstruction System is substantially equivalent to similar legally marketed occipito-cervico-thoracic fixation devices including the Synthes Spine Occipital-Cervical Plate/Rod and Hook System (K982322), the OctaFix Occipital Cervical Plating System (K021009), the Synthes CerviFix® System (K023675), the Summit OCT Spinal System (K010681), and the Interpore Cross International OCT Rod and Plate System (K022048).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized wings.

Public Health Service

SEP 2 3 2005

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: K052402

Trade/Device Name: VERTEX® Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: II Product Code: KWP, MNI Dated: August 31, 2005 Received: September 1, 2005

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 (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 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/industry/support/index.html.

Sincerely yours,

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

Enclosure

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Page 1 of 1

August 2005

510(k) Number (if known): 1605 L 402

Device Name: _ VERTEX® Reconstruction System

Indications for Use:

When intended to promote fusion of the occipitocervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated 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 Plate/Rod/Occipital Screws/Hooks

The use of the occipitocervical plate/rod requires bilateral fixation to C2 and below. Note: segmental fixation is recommended for these constructs.

Hooks and Rods

'I'he 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 (3.5mm and 4.0mm cancellous, and 4.0mm cortical) are limited to placement in T1-T3. The screws are not intended to be placed in the cervical spine.

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

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)

(Division Sign-Off)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,

and Neurological Devices

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E1A/1-1 Mormahan V n 5 2 412

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.