ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM

K994239 · Medtronic Sofamor Danek, Inc. · KWQ · Jun 19, 2000 · Orthopedic

Device Facts

• Record ID: K994239
• Device Name: ZEPHIR ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 19, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ZEPHIR™ 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

ZEPHIR™ Anterior Cervical Plate System is a spinal fixation implant; consists of titanium alloy bone plates with pre-assembled locking mechanisms, bone screws, and associated surgical instruments. Used by surgeons in an operating room setting for anterior interbody fixation of the cervical spine. Provides temporary stabilization during spinal fusion procedures. Implanted via anterior approach to the cervical spine. Benefits patients by stabilizing the spine to facilitate fusion in cases of degeneration, trauma, tumors, or deformity. Mechanical performance validated via bench testing.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: Titanium alloy per ASTM F-136. Components: Bone plates with pre-assembled locking mechanisms, bone screws, and instruments. Energy source: None (mechanical). Connectivity: None. Sterilization: Supplied sterile or non-sterile.

Indications for Use

Indicated for temporary stabilization of the anterior cervical spine during fusion in patients with degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, or 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.

Submission Summary (Full Text)

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

## ZEPHIR™ Anterior Cervical Plate System 510(k) Summary December 15, 1999

| I. | Company: | Medtronic Sofamor Danek<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>[phone] |
|-----|----------------------|---------------------------------------------------------------------------------------------|
| II. | Product Name: | ZEPHIR™ Anterior Cervical Plate System |
| | Classification Name: | Spinal intervertebral body fixation orthosis |

- III. The ZEPHIR™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (locking mechanism is pre-assembled to 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 as described by ASTM F-136 and may be supplied either sterile or non-sterile.
- IV. The ZEPHIR™ 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.

- V. The ZEPHIR™ Anterior Cervical Plate System was claimed to be substantially equivalent to other commercially available cervical plating systems.
Mechanical test data were provided in support of this notification.

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

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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is a symbol of medicine and healing, and the logo is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN 1 9 2000

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

Re: K994239

Trade Name: Zephir Anterior Cervical Plate System Regulatory Class: II Product Code: K WQ Dated: April 10, 2000 Received: April 11, 2000

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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.

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

Page 2 - Richard W. Treharne, Ph.D.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dune R. Lochner -

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

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

510(k) Number (if known): JK994239

ZEPHIR™ Anterior Cervical Plate System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The ZEPHIR™ 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.

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Durne R. Vochner.

ision Sign-Off)
ision of General Restorative Devices
(k) Number K994239

Prescription Use (Per 21 CFR 801.109) ાર

Over-The-Counter Use

(Optional Format 1-

2-96)