VENTURE ANTERIOR CERVICAL PLATE SYSTEM

K061274 · Medtronic Sofamor Danek · KWQ · May 25, 2006 · Orthopedic

Device Facts

• Record ID: K061274
• Device Name: VENTURE ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWQ · Orthopedic
• Decision Date: May 25, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VENTURE™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

VENTURE™ Anterior Cervical Plate System provides temporary stabilization of anterior cervical spine during fusion. System comprises titanium alloy bone plates and screws; locking mechanism utilizes Nitinol (shape memory metal). Surgeons perform anterior approach to insert bone screws into vertebral bodies. Device modifications include addition of fixed and variable angle screws. Used in clinical/surgical settings by physicians. Provides mechanical fixation to support spinal fusion; benefits patients by stabilizing spine during healing process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Components: titanium alloy plates/screws, Nitinol (shape memory metal) locking mechanism. Mechanical fixation via anterior approach. No software or electronic components.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization during fusion. Conditions include degenerative disc disease (discogenic neck pain), trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, and failed previous fusions. Contraindicated for posterior element (pedicle) attachment in cervical, thoracic, or lumbar spine.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• VENTURE™ Anterior Cervical Plate System (K042922)

Submission Summary (Full Text)

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K0611274

## VENTURE™ Anterior Cervical Plate System Special 510(k) Summary May 3, 2006

# MAY 2 5 2006

| 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: | VENTURE™ Anterior Cervical Plate System |
| | Classification Name: | Spinal intervertebral body fixation orthosis |
| | Regulation Number: | 888.3060 |
| | Code: | KWQ |

#### III. Description:

The VENTURE™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The implant components will be made from titanium alloy and may be supplied either sterile. The locking plate is manufactured from shape memory metal (Nitinol). The purpose of the application is to add modified fixed and variable angle screws to the system.

#### IV Indications

The VENTURE™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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### IV. Substantial Equivalence:

The subject VENTURE™ Anterior Cervical Plate System components were demonstrated to be substantially equivalent to the predicate VENTURE™ Anterior Cervical Plate screw and plate components cleared in K042922.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2006

Medtronic Sofamor Danek USA, Inc. % Richard W. Treharne, Ph.D. Senior VP, Regulatory Affairs 1800 Pyramid Place Memphis. Tennessee 38132

Re: K061274

Trade/Device Name: VENTURE™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 3, 2006 Received: May 8, 2006

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 (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.

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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/industry/support/index.html.

Sincerely yours,

Helmut Lener nos

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _1 of

May 2006

510(k) Number (if known): 1506 127 VENTURETM Anterior Cervical Plate System Device Name:

Indications For Use:

The VENTURE™ Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions.

Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Prescription Use X (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)

Hebert Lemond

Division of General, Restorative, and Neurological Devices

**510(k) Number** k061274