ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM

K021461 · Medtronic Sofamor Danek · KWQ · Jul 22, 2002 · Orthopedic

Device Facts

• Record ID: K021461
• Device Name: ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 22, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions. Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

Device Story

ATLANTIS Anterior Cervical Plate System provides temporary stabilization of anterior cervical spine during fusion. System comprises titanium alloy bone plates, preassembled set screws, washers, and associated surgical instruments. Surgeon implants device via anterior approach, inserting bone screws into vertebral bodies. Device maintains alignment during bone healing. Used in clinical/OR settings by orthopedic or neurosurgeons. Benefits include structural support for fusion in patients with degenerative disease, trauma, tumors, or deformity. Not for posterior pedicle fixation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy (ASTM F136 or ISO 5832-3). Components include bone plates, preassembled set screws, and washers. Mechanical fixation via anterior screw insertion. Not compatible with stainless steel components.

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 posterior element (pedicle) attachment.

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)

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# ATLANTIS™ Anterior Cervical Plate System 510(k) Summarv May 2002

े

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

#### 111. Device Description:

The ATLANTIS™ Anterior Cervical Plate System consists of a variety of shapes and sizes of bone plates (set screws and washers are preassembled to the 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 ATLANTIS™ Anterior Cervical Plate System implant components are made from titanium allov described by ASTM F136 or ISO 5832-3. Stainless steel and titanium implant components must not be used together in a construct. MEDTRONIC SOFAMOR DANEK expressly warrants that these devices are fabricated from the foregoing material No other warranties, express or implied, are made. specification. Implied warranties of merchantability and fitness for a particular purpose or use are specifically excluded. Do not use any of the ATLANTIS™ Anterior Cervical Plate System components with the components from any other system or manufacturer.

### IV. Device Indications:

Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

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

# V.

Substantial Equivalence:
The ATLANTIS™ Anterior Cervical Plate System was claimed to be substantially equivalent to itself.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized representation of a human figure, with three profiles overlapping to suggest community and support.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 2 2002

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

K021461 Re:

> Trade/Device Name: Atlantis™ Vision Anterior Cervical System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: June 24, 2002 Received: June 25, 2002

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of vour device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Mark N Millikan

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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510(k) Number (if known):

Device Name: ATLANTISTM Anterior Cervical Plate System

### Indications for Use:

Properly used, this system is intended for anterior interbody screw fixation of the cervical spine. The indications and contraindications of spinal instrumentation systems should be well understood by the surgeon. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) trauma (including fractures), 3) tumors, 4) deformity (defined as kyphosis, lordosis, or scoliosis), 5) pseudarthrosis, and/or 6) failed previous fusions.

Nota Bene: This device system is intended for anterior cervical intervertebral body fusions only.

WARNING: This device is not approved for screw attachment to the 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 Evaluation (ODE)

OR

Prescription Use (Per 21 CFR 801.109) (Optional 1-2-96)

Over-the-counter Use

Mark N. Milken

Division Sign-Off) Division of General. Restorative and Neurological Devices

510(k) Number K021961

00004.