VENTURE ANTERIOR CERVICAL PLATING SYSTEM

K042922 · Medtronic Sofamor Danek, Inc. · KWQ · Nov 19, 2004 · Orthopedic

Device Facts

• Record ID: K042922
• Device Name: VENTURE ANTERIOR CERVICAL PLATING SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 19, 2004
• Decision: SESE
• Submission Type: Traditional
• 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.

Device Story

VENTURE™ Anterior Cervical Plate System consists of titanium alloy bone plates, screws, and associated instruments; locking plate manufactured from Nitinol (shape memory metal). Used for anterior interbody screw fixation of cervical spine to provide temporary stabilization during fusion. Operated by surgeons in clinical settings. System components are identical to predicate ORION® system; submission represents a trade name change for a subset of existing components.

Clinical Evidence

No clinical data. Substantial equivalence supported by comparison test data demonstrating identity to predicate devices.

Technological Characteristics

Materials: Titanium alloy (plates/screws), Nitinol (locking plate). Components supplied sterile or non-sterile. Mechanical fixation via anterior screw insertion into vertebral body.

Indications for Use

Indicated for patients requiring temporary stabilization of the anterior cervical spine during fusion. Conditions include degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, and failed previous fusions. Contraindicated for screw attachment to posterior elements (pedicles) of the 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

• ORION® Anterior Cervical Plate (K042235)
• ORION® Anterior Cervical Plate (K042499)

Submission Summary (Full Text)

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| | NOV 19 2004 | VENTURE™ Anterior Cervical Plate System<br>Traditional 510(k) Summary – K042922<br>November 2004 |
|-----|--------------------------------------------------|--------------------------------------------------------------------------------------------------|
| I. | Company: | Medtronic Sofamor Danek USA<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>[phone] |
| | Contact: | Richard Treharne<br>Sr. Vice President Regulatory Affairs |
| II. | Product Name: | VENTURE™ Anterior Cervical Plate System |
| | Classification Name:<br>Classification No./Code: | Spinal intervertebral body fixation orthosis<br>888.3060 - KWO |

- Description: The VENTURE™ Anterior Cervical Plate System consists of a variety of shapes III. 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 or non-sterile. The locking plate is manufactured from shape memory metal (Nitinol).
- Indications: The VENTURE™ Anterior Cervical Plate System is intended for anterior interbody IV. 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.

- Substantial Equivalence: The subject VENTURE™ Anterior Cervical Plate System components V. were demonstrated to be identical to the predicate ORION® Anterior Cervical Plate screw and plate components cleared in K042235 and K042499. Comparison test data were provided in support of this notification. The sole purpose of this submission was to change the trade name of a subset of the ORION® Anterior Cervical Plate System to the VENTURE™ Anterior Cervical Plate System.

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Image /page/1/Picture/1 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 that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2004

Richard W. Treharne, Ph.D. Senior Vice President, Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K042922

Trade/Device Name: VENTURE™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: October 19, 2004 Received: October 22, 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. Drue. 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/dsma/dsmamain.html

Sincerely vours.

Mark A. Melberson

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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## October 2004

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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, or scoliosis), pseudarthrosis, and/or failed previous fusions.

This device is not approved for screw attachment or fixation to the Warning: 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)

to Mark N. Milherson
Division Sign Off

torative. and Neurological Learices

510(k) Number K042900000