VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM

K110522 · Medtronic Sofamor Danek USA, Inc. · KWP · Apr 1, 2011 · Orthopedic

Device Facts

• Record ID: K110522
• Device Name: VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Apr 1, 2011
• 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 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

Posterior spinal fixation system; consists of plates, rods, hooks, screws, multi-axial screws, and connecting components; tailor-made constructs for individual cases; used to provide stabilization to promote fusion; implanted by surgeons in clinical settings; components fabricated from medical grade titanium, titanium alloy, and cobalt chromium; includes Nitinol retaining rings and silicone adhesive stakes; system allows for cable attachment via ATLAS Cable System; may connect to CD HORIZON Spinal System for additional fixation levels; provides mechanical stabilization to the occipitocervical junction and cervical/thoracic spine; aids in patient recovery by supporting fusion following trauma or degenerative conditions.

Clinical Evidence

No clinical data provided. The submission relies on the substantial equivalence of the device to previously cleared systems; no changes were made to the implant components or surgical process.

Technological Characteristics

System components made of medical grade titanium, titanium alloy, and cobalt chromium. Includes Nitinol (NiTi) retaining rings and silicone adhesive elastomeric stakes. Modular design for posterior spinal fixation. Not compatible with stainless steel. Manual assembly of constructs.

Indications for Use

Indicated for skeletally mature patients requiring fusion of the occipitocervical, cervical, and thoracic (Occiput-T3) spine using allograft/autograft for DDD, spondylolisthesis, spinal stenosis, fracture, dislocation, failed fusion, or tumors.

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)
• Traverse OCT Spinal Fixation System (K062447)
• Modification to Vertex Reconstruction System (K070742)
• Vertex Reconstruction System, Vertex Select Reconstruction System (K082728)
• Vertex Reconstruction System (K083071)
• Vertex Reconstruction System, Vertex Select Reconstruction System (K090714)
• Vertex Reconstruction System, Vertex Select Reconstruction System (K091365)

Reference Devices

• CD HORIZON Spinal System

Submission Summary (Full Text)

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APR - 1 20i1

### 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 | 2600 Pyramid Place Memphis, TN 38132 | | | | | | | | | | | | | | | | | | | | | | | | |
| Phone number | 901-344-1463 | | | | | | | | | | | | | | | | | | | | | | | | |
| Fax number | 901-346-9738 | | | | | | | | | | | | | | | | | | | | | | | | |
| Establishment<br>Registration<br>Number | 1030489 | | | | | | | | | | | | | | | | | | | | | | | | |
| Name of contact<br>person | Nicholas Tabrizi | | | | | | | | | | | | | | | | | | | | | | | | |
| Date prepared | March 17, 2011 | | | | | | | | | | | | | | | | | | | | | | | | |
| Name of device | | | | | | | | | | | | | | | | | | | | | | | | | |
| Trade or<br>proprietary name | VERTEX® Reconstruction System | | | | | | | | | | | | | | | | | | | | | | | | |
| Common or usual<br>name | VERTEX SELECT® Reconstruction System | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification<br>name | Spinal Interlaminal Fixation Orthosis | | | | | | | | | | | | | | | | | | | | | | | | |
| Classification panel | Class II | | | | | | | | | | | | | | | | | | | | | | | | |
| Regulation | 21 CFR 888.3050 | | | | | | | | | | | | | | | | | | | | | | | | |
| Product Code(s) | KWP | | | | | | | | | | | | | | | | | | | | | | | | |
| Legally marketed<br>device(s) to which<br>equivalence is claimed | 510(k) Number Title Date Cleared K003780 Vertex Reconstruction System 9/28/01 K062447 Traverse OCT Spinal Fixation System 10/15/07 K070742 Modification to Vertex Reconstruction System 9/14/07 K082728 Vertex Reconstruction System, Vertex Select Reconstruction System 1/16/09 K083071 Vertex Reconstruction System 11/14/08 K090714 Vertex Reconstruction System, Vertex Select Reconstruction System 4/17/09 K091365 Vertex Reconstruction System, Vertex Select Reconstruction System 8/6/09 | | | | | | | | | | | | | | | | | | | | | | | | |
| Reason for 510(k)<br>submission | The purpose of this 510(k) is to consolidate several cleared surgical techniques<br>into two concise documents. | | | | | | | | | | | | | | | | | | | | | | | | |
| Device description | The VERTEX SELECT Reconstruction System is a posterior system, which<br>consists of a variety of shapes and sizes of plates, rods, hooks, screws, multi-<br>axial screws, and connecting components, which can be rigidly locked to the<br>rod in a variety of configurations, with each construct being tailor-made for the<br>individual case. Titanium ATLAS® cable may be used with this system at the | | | | | | | | | | | | | | | | | | | | | | | | |

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| surgeon's discretion. See the package inserts of both of those systems for<br>labeling limitations. | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The VERTEX Reconstruction System is fabricated from medical grade titanium,<br>medical grade titanium alloy, and medical grade cobalt chromium. Medical<br>grade titanium, medical grade titanium alloy, and/or medical grade cobalt<br>chromium may be used together. Never use titanium, titanium alloy, and/or<br>cobalt chromium with stainless steel in the same construct. The VERTEX<br>Reconstruction System includes a retaining ring for the multi-axial screw made<br>of Shape Memory Alloy (Nitinol - NiTi). Shape Memory Alloy is compatible with<br>titanium, 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 System<br>implant components with components from any other system or manufacturer<br>unless specifically labeled to do so in this or another MEDTRONIC document.<br>As with all orthopaedic and neurosurgical implants, none of the VERTEX<br>Reconstruction System components should ever be reused under any<br>circumstances. | |
| Intended use of the<br>device | When intended to promote fusion of the occipitocervical spine, cervical spine,<br>and the thoracic spine, (Occiput-T3), the VERTEX Reconstruction System is<br>indicated for the following: DDD (neck pain of discogenic origin with<br>degeneration of the disc confirmed by history and radiographic studies),<br>spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion<br>and/or tumors. |
| Indications for use | When intended as an adjunct to fusion of the occipitocervical spine, cervical<br>spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction<br>System is indicated for skeletally mature patients using allograft and/or<br>autograft for the following:<br>DDD (neck pain of discogenic origin with degeneration of the disc confirmed by<br>history and radiographic studies), spondylolisthesis, spinal stenosis, fracture,<br>dislocation, failed previous fusion and/or tumors. |
| | Occipitocervical Components: Plate Rod/Plates/Rods/Occipital<br>Screws/Hooks |
| | The occipitocervical plate rods, plates, rods, occipital screws, and hooks are<br>intended to provide stabilization to promote fusion following reduction of<br>fracture/dislocation or trauma in the occipitocervical junction and the cervical<br>spine. When used to treat these occipitocervical and cervical conditions, these<br>screws are limited to occipital fixation only. The screws are not intended to be<br>placed in the cervical spine. |
| Occipitocervical constructs require bilateral fixation to C2 and below.<br>Note: Segmental fixation is recommended for these constructs.<br>Hooks and Rods<br>The hooks and rods are also intended to provide stabilization to promote fusion<br>following reduction of fracture/dislocation or trauma in the cervical/upper<br>thoracic (C1-T3) spine. | |
| | Multi-axial Screws/Connectors<br>The use of multi-axial screws are limited to placement in T1-T3. The screws<br>are not intended to be placed in the cervical spine.<br>Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction<br>System allows for cable attachment to the posterior cervical or thoracic spine. |

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| 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. | | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Summary of the technological characteristics of the device compared to the predicate device | | | |
| Characteristic | New Device | Predicate [Device Name]<br>[510(k) number] | |
| Surgical Technique | VERTEX SELECT®<br>Reconstruction System Surgical<br>Technique | Vertex Reconstruction System, K003780<br>Modification to the Vertex Reconstruction<br>System, K0070742<br>Vertex Reconstruction System, Vertex<br>Select Reconstruction System, K082728<br>Vertex Reconstruction System, K083071<br>Vertex Reconstruction System, Vertex<br>Select Reconstruction System, K090714<br>Vertex Reconstruction System, Vertex<br>Select Reconstruction System, K091365<br>Traverse™ OCT Spinal Fixation System,<br>K062447 | |
| Surgical Technique | VERTEX SELECT®<br>Reconstruction System Posted<br>Screw Module Surgical<br>Technique | Modification to the Vertex Reconstruction<br>System, K0070742<br>Vertex Reconstruction System, K083071 | |
| PERFORMANCE DATA | | | |
| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL<br>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<br>EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | |
| Not Applicable | | | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | | | |
| Not Applicable; the system did not change. The surgical techniques were only updated to | | | |

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provide more detail. The overall implant process did not change.

.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized lines forming the body and wings.

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

Medtronic Sofamor Danek USA. Inc. % Mr. Nicholas Tabrizi Senior Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

APR - 1 2011

Re: K110522

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: March 21, 2011 Received: March 22, 2011

Dear Mr. Tabrizi:

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 warranties. We remind you; 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.

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

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Page 2 - Mr. Nicholas Tabrizi

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.

ff you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersQffices/CDRH/CDRHQffices/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,

Aling B. nh

Mark N. Melkerson 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): K110522

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 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)

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

K110522 510(k) Number_

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