VERTEX RECONSTRUCTION SYSTEM

K042498 · Medtronic Sofamor Danek · KWP · Oct 7, 2004 · Orthopedic

Device Facts

• Record ID: K042498
• Device Name: VERTEX RECONSTRUCTION SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWP · Orthopedic
• Decision Date: Oct 7, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Posterior spinal reconstruction system; consists of rods, hooks, screws, multi-axial screws, and connecting components; titanium or titanium alloy construction; includes Nitinol (NiTi) retaining ring for multi-axial screws. Used by surgeons in clinical settings to stabilize cervical/thoracic spine (C1-T3) to promote fusion. Components rigidly locked to rods in custom configurations per patient anatomy. ATLAS™ cable system allows additional posterior attachment. Device provides mechanical stabilization; supports fusion process; benefits patients by addressing degenerative conditions, trauma, or failed prior surgeries. Not for use with stainless steel.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Medical grade titanium, titanium alloy, and Nitinol (NiTi) shape memory alloy. Components: Rods, hooks, screws (3.5mm, 4.0mm, 4.5mm cancellous; 4.0mm cortical), connectors. Configuration: Posterior spinal interlaminal fixation orthosis. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients requiring cervical and thoracic (C1-T3) spinal fusion due to DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion, or tumors. Screws are restricted to T1-T3 thoracic use only; not for cervical spine.

Regulatory Classification

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.

Predicate Devices

• VERTEX™ Reconstruction System (K003780)

Submission Summary (Full Text)

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OCT 7 - 2004

042498

### VERTEX™ Reconstruction System 510(k) Summary September 2004

| I. | Company: | Medtronic Sofamor Danek USA, Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>[phone] |
|-----|----------------------|-------------------------------------------------------------------------------------------------------|
| | Contact: | Richard W. Treharne, Ph.D.<br>Senior Vice President, Regulatory Affairs |
| II. | Product Name: | VERTEXTM 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 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 or titanium alloy. The VERTEX™ Reconstruction System also includes a retaining ring for the multi-axial screw made of Shape Memory Alloy (Nitinol - NiTì). Shape Memory Alloy is compatible with titanium or titanium alloy implants only. Do not use with stainless steel.

The purpose of this submission was to modify the previously cleared multi axial screws.

### IV Indications

When intended to promote fusion of the cervical spine and the thoracic spine, (CI-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.

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### 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 modified VERTEX™ Reconstruction System multi axial screws are substantially equivalent to VERTEX™ Reconstruction System multi axial screws previously cleared in K003780.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

OCT 7 - 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: K042498

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 13, 2004 Received: September 14, 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.

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Milberson

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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510(k) Number (if known): K542498

VERTEXTM Reconstruction System Device Name: _________________________________________________________________________________________________________________________________________________________________

# Indications for Use

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

# 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 TI-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.

AND/OR Over-The-Counter Use Prescription Use X (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 (ODE)

Mark N Milburn

Division of General, Restorative, and Neurological Devices

**510(k) Number** K042498

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