VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM

K090714 · Medtronic Sofamor Danek · KWP · Apr 17, 2009 · Orthopedic

Device Facts

• Record ID: K090714
• Device Name: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWP · Orthopedic
• Decision Date: Apr 17, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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. 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. 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. 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.

Device Story

Posterior spinal fixation system; consists of plates, rods, hooks, screws, and multi-axial screws; provides stabilization to promote fusion in occipitocervical, cervical, and thoracic spine (Occiput-T3). Used by surgeons in clinical/OR settings. Components are tailor-made for individual patient anatomy; rigidly locked into configurations. Includes Nitinol retaining rings and silicone elastomeric stakes. May be used with ATLAS® cable system or connected to CD HORIZON® Spinal System for additional fixation levels. Benefits patient by providing structural stabilization during bone fusion process. Mechanical testing confirms equivalence to predicate systems.

Clinical Evidence

Bench testing only. No clinical data presented.

Technological Characteristics

Materials: medical grade titanium, titanium alloy, cobalt chromium, Nitinol (NiTi) shape memory alloy, and silicone adhesive. Components: plates, rods, hooks, screws, multi-axial screws, and connectors. System is a posterior spinal interlaminal fixation orthosis. Non-software device.

Indications for Use

Indicated for skeletally mature patients requiring fusion of the occipitocervical, cervical, and thoracic spine (Occiput-T3) for DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed fusion, or tumors. Contraindicated for use of multi-axial screws in the cervical spine; occipital screws limited to occipital fixation.

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)
• VERTEX® Reconstruction System (K042789)
• VERTEX® Reconstruction System (K052376)
• VERTEX® Reconstruction System (K053483)
• CD HORIZON® Spinal System (K014296)

Submission Summary (Full Text)

{0}------------------------------------------------

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 USA<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>Telephone: [phone]<br>Fax: [phone] |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 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.

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.

#### V. Indications for Use:

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.

page 1 of 2

{1}------------------------------------------------

K090714

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.

- 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

{2}------------------------------------------------

## 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.

{3}------------------------------------------------

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 [phone]. 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 [phone] or [phone] 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

{4}------------------------------------------------

# 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:

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 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.

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.

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