K Number
K042524
Device Name
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
Date Cleared
2004-10-08

(21 days)

Product Code
Regulation Number
888.3050
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEXTM 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. 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. Screws/Connectors: The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. 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.
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 cach 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 medical grade titanium alloy implants only. Do not use with stainless steel. The purpose of this submission was to add modified CROSSLINK® Plates and set screws to the system.
More Information

No
The device description focuses on the mechanical components of a spinal reconstruction system (rods, hooks, screws, cables, plates) and their materials. There is no mention of software, algorithms, image processing, or any terms related to AI or ML.

Yes.
The device is a medical implant system used to provide stabilization and promote fusion in the cervical and thoracic spine for various spinal conditions, fitting the definition of a therapeutic device.

No

This device is a surgical implant system designed to promote fusion and provide stabilization in the cervical and thoracic spine. It consists of rods, hooks, screws, and connectors, all of which are used in treatment rather than diagnosis.

No

The device description explicitly lists hardware components such as rods, hooks, screws, multi-axial screws, connecting components, and cables, all fabricated from medical grade titanium alloy and Shape Memory Alloy. This indicates it is a physical implant system, not a software-only device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Description: The VERTEX™ Reconstruction System is a surgical implant consisting of rods, hooks, screws, and connecting components used to stabilize the spine.
  • Intended Use: The intended use is to promote fusion of the cervical and thoracic spine for various conditions like DDD, spondylolisthesis, and fracture. This is a surgical intervention, not a diagnostic test performed on a sample.

The device is a surgical implant used for treatment and stabilization, not for diagnosing a condition using in vitro methods.

N/A

Intended Use / Indications for Use

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEXTM 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.

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.

Screws/Connectors

The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. 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.

Product codes

KWP

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 cach 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 medical grade titanium alloy implants only. Do not use with stainless steel.

The purpose of this submission was to add modified CROSSLINK® Plates and set screws to the system.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cervical spine, thoracic spine (C1-T3)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K023555, K003780

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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K042524

OCT 8 - 2004 VERTEX™ Reconstruction System 510(k) Summary September 2004

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

III. 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 cach 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 medical grade titanium alloy implants only. Do not use with stainless steel.

The purpose of this submission was to add modified CROSSLINK® Plates and set screws to the system.

IV Indications

When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the VERTEXTM 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

1

042529

fusion and/or tumors.

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.

Screws/Connectors

The use of screws (3.5mm, 4.0mm and 4.5mm cancellous and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. 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.

V. Substantial Equivalence:

Documentation has been provided which demonstrates that the VERTEX™ Reconstruction System is substantially equivalent to VERTEX™ Reconstruction System that was previously cleared in K023555 and K003780.

ping 2.of 2

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

OCT 8 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K042524

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: September 14, 2004 Received: September 17, 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

3

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/dsma/dsmamain.html

Sincerely yours,

Marli N Millerm

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

4

510(k) Number (if known): K042524

Device Name: _________________ VERTEX™ Reconstruction System

Indications for Use

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-T3), the VERTEXTM 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.

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.

Screws/Connectors

The use of screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

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

Prescription Use AND/OR Over-The-Counter Use × (Part 21 CFR 801 Subpart D) (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

L. Mark A. Wilkerson

Division of General, Restorative, and Neurological Devices

510(k) Number K04-