VERTEX RCCONSTRUCTION SYSTEM

K121191 · Medtronic Sofamor Danek, Inc. · KWP · Jun 29, 2012 · Orthopedic

Device Facts

• Record ID: K121191
• Device Name: VERTEX RCCONSTRUCTION SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jun 29, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

VERTEX® Reconstruction System is a posterior spinal fixation system comprising plates, rods, hooks, and screws. Used by surgeons in clinical settings to stabilize the occipitocervical, cervical, and upper thoracic spine (Occiput-T3) to promote fusion. Components are tailor-made for individual patient constructs. System includes multi-axial screws and connectors for integration with CD HORIZON® Spinal System. Device provides mechanical stabilization following trauma or degenerative conditions, potentially reducing pain and restoring spinal alignment. No software or electronic components.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Constructed from medical grade titanium, titanium alloy, and cobalt chromium. Includes Nitinol (NiTi) retaining rings and silicone adhesive elastomeric stakes. System is a posterior spinal fixation orthosis. No energy source or software.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion (Occiput-T3) using allograft/autograft for DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed fusion, or tumors. Occipitocervical components provide stabilization for fracture/dislocation/trauma. Multi-axial screws limited to T1-T3; not for 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 (K090714)
• VERTEX® Reconstruction System (K082728)
• VERTEX® Reconstruction System (K083071)
• VERTEX® Reconstruction System (K042789)

Reference Devices

• CD HORIZON® Spinal System
• ATLAS® Cable System

Submission Summary (Full Text)

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# JUN 2 9 2012

# 510(k) Summary

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| Submitter Information | | | |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|-----------------|
| Name | Medtronic Sofamor Danek USA, Inc. | | |
| Address | 1800 Pyramid Place Memphis, TN 38132 | | |
| Phone number | 901-344-0804 / 901-344-1463 | | |
| Fax number | 901-346-9738 | | |
| Establishment<br>Registration<br>Number | 1030489 | | |
| Name of contact<br>person | Claire Evans / Nicholas Tabrizi | | |
| Date prepared | April 18, 2012 | | |
| Name of device | | | |
| Trade or<br>proprietary name | VERTEX® Reconstruction System | | |
| Common or Usual<br>name | Metallic Orthopedic Plate, Rod and Screw | | |
| Classification<br>name | Spinal Interlaminal Fixation Orthosis, Single/Multiple Component<br>Metallic Bone Fixation Appliances and Accessories, Pedicle Screw<br>System | | |
| Classification | Class II | | |
| Regulation | 888.3050 | | |
| Product Code(s) | KWP | | |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | 510(k)<br>Number | Title | Date<br>Cleared |
| | K090714 | VERTEX® Reconstruction System,<br>VERTEX SELECT® Reconstruction<br>System | 4/17/09 |
| | K082728 | VERTEX® Reconstruction System,<br>VERTEX SELECT® Reconstruction<br>System | 1/16/09 |
| | K083071 | VERTEX® Reconstruction System | 11/14/08 |
| | K042789 | VERTEX® Reconstruction System | 12/21/04 |
| Reason for 510(k)<br>submission | The purpose of this 510(k) is to modify the connectors and add a 5.5mm<br>multi-axial screw to the VERTEX® SELECT Reconstruction System.<br>Two changes are being proposed to the connectors: (1) The thread<br>depth and drill depth of the set screw threaded hole on the connector is<br>increasing and (2) the tolerance on the rod slot diameter will be<br>widened. | | |

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| Device description | The VERTEX SELECT® Reconstruction System is a posterior system,<br>which consists of a variety of shapes and sizes of plates, rods, hooks,<br>screws, multi-axial screws, and connecting components, which can be<br>rigidly locked to the rod in a variety of configurations, with each construct<br>being tailor-made for the individual case. Titanium ATLAS® cable may<br>be used with this system at the surgeon's discretion. See the package<br>inserts of both of those systems for labeling limitations.<br><br>The VERTEX® Reconstruction System is fabricated from medical grade<br>titanium, medical grade titanium alloy, and medical grade cobalt<br>chromium. Medical grade titanium, medical grade titanium alloy, and/or<br>medical grade cobalt chromium may be used together. Never use<br>titanium, titanium alloy, and/or cobalt chromium with stainless steel in<br>the same construct. The VERTEX® Reconstruction System includes a<br>retaining ring for the multi-axial screw made of Shape Memory Alloy<br>(Nitinol - NiTi). Shape Memory Alloy is compatible with titanium,<br>titanium alloy, and cobalt chromium implants only. Some components<br>contain elastomeric stakes made of silicone adhesive commonly used in<br>implantable medical devices. Do not use with stainless steel.<br>To achieve best results, do not use any of the VERTEX® Reconstruction<br>System implant components with components from any other system or<br>manufacturer unless specifically labeled to do so in this or another<br>MEDTRONIC document. As with all orthopaedic and neurosurgical<br>implants, none of the VERTEX® Reconstruction System components<br>should ever be reused under any circumstances. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use of the<br>device | When intended to promote fusion of the occipitocervical spine, cervical<br>spine, and the thoracic spine, (Occiput-T3), the VERTEX®<br>Reconstruction System is indicated for the following: DDD (neck pain of<br>discogenic origin with degeneration of the disc confirmed by history and<br>radiographic studies), spondylolisthesis, spinal stenosis, fracture,<br>dislocation, failed previous fusion and/or tumors. |
| Indications for use | When intended as an adjunct to fusion of the occipitocervical spine,<br>cervical spine, and the thoracic spine (Occiput-T3), the VERTEX®<br>Reconstruction System is indicated for skeletally mature patients using<br>allograft and/or autograft for the following:<br>DDD (neck pain of discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies), spondylolisthesis, spinal<br>stenosis, fracture, dislocation, failed previous fusion, and/or tumors.<br><br>Occipitocervical Components: Plate Rod/Plates/Rods/Occipital<br>Screws/Hooks<br>The occipitocervical plate rods, plates, rods, occipital screws, and hooks<br>are intended to provide stabilization to promote fusion following<br>reduction of fracture/dislocation or trauma in the occipitocervical junction<br>and the cervical spine. When used to treat these occipitocervical and<br>cervical conditions, these screws are limited to occipital fixation only.<br>The screws are not intended to be placed in the cervical spine.<br><br>Occipitocervical constructs require bilateral fixation to C2 and below.<br>Note: Segmental fixation is recommended for these constructs. |

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.

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| Hooks and Rods<br>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<br>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.<br>Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine. | | | |
| Connectors<br>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. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use. | | | |
| Summary of the technological characteristics of the device compared to the predicate device | The primary change from the predicate devices for the connectors is the minimum thread depth and maximum drill depths are increased on the subject device. In relation with the depth changes, the tolerance on the wide slot diameter was widened to accommodate the increase in thread depth and drill depth.<br><br>The primary change from the predicate devices for the multi-axial screw is the diameter is being increased from 4.5mm to 5.5mm on the subject device. | | |
| PERFORMANCE DATA | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE | | | |
| Performance Test Summary-New Device | | | |
| Characteristic | Standard/Test/FDA Guidance | Results Summary | |
| N/A | N/A | N/A | |
| Comparative Performance Information Summary | | | |
| Characteristic | Requirement | New Device | Predicate Device |
| N/A | N/A | N/A | N/A |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | |
| Not Applicable | | | |

·

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# CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

The changes proposed to the connectors: 1)increasing thread and drill depth of the set screw hole on the connector and 2) widening the tolerance on the rod slot diameter, as well as the changes to the multi-axial screw, do not require additional bench testing since neither presents a new worse case scenario. Therefore, the subject VERTEX® Reconstruction System connectors and multi-axial screw are safe and effective and perform as well as the predicate VERTEX ® Reconstruction System connectors and multi-axial screw.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

JUN 2 9 2012

Medtronic Sofamor Danek USA, Inc. % Ms. Claire Evans Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K121191

> Trade/Device Name: Vertex® Reconstruction System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: KWP Dated: April 18, 2012 Received: April 19, 2012

Dear Ms. Evans:

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 note: CDRH does not evaluate information related to contract liability addition. Trease noter, u, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2- Ms. Claire Evans

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Pete D'Amico

Mark N. M Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K12 11 91

Device Name: VERTEX® Reconstruction System

### 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 usinq 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

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.

#### Connectors

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. Transition rods with differing diameters may also be used to connect the VERTEX® Reconstruction System to the CD HORIZON® Spinal System screws, hooks, and connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

| Prescription Use | X |
|------------------|---|
|------------------|---|

Over-The-Counter Use AND/OR

4 CFR 907 Subpart C)

(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)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

(s) Number K12191