ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

K081038 · Medtronic Sofamor Danek · KWQ · Aug 15, 2008 · Orthopedic

Device Facts

• Record ID: K081038
• Device Name: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Medtronic Sofamor Danek
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Properly used, this system is intended for anterior interbody screw/plate fixation from C2 to T1. 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; temporary implant for anterior interbody screw fixation of cervical spine. Components: bone plates, screws, associated instruments. Operation: bone screws inserted into vertebral body via anterior approach to provide stabilization during spinal fusion. Used in clinical/surgical settings by surgeons. Benefits: provides temporary stabilization to facilitate fusion. Materials: titanium alloy; some plates include superelastic Nitinol-NiT subcomponents. Not for posterior element attachment.

Clinical Evidence

No clinical data. Substantial equivalence based on risk analysis and mechanical testing.

Technological Characteristics

Materials: titanium alloy, superelastic Nitinol-NiT. Form factor: bone plates and screws for anterior cervical fixation. Energy source: none (mechanical). Sterilization: not specified. Software: none.

Indications for Use

Indicated for temporary stabilization of anterior cervical spine (C2-T1) 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.

Predicate Devices

• ATLANTIS® Anterior Cervical Plate System (K970806)
• ATLANTIS® Anterior Cervical Plate System (K021461)
• ATLANTIS® Anterior Cervical Plate System (K063100)
• C-Tek® MaxAn™ Anterior Cervical Plate System (K080646)

Submission Summary (Full Text)

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K081033 (fg 1 of 2)

## ATLANTIS® Anterior Cervical Plate System

# AUG 1 5 2008

## 510(k) Summary

### July 2008

I. Company: Medtronic Sofamor Danek USA 1800 Pyramid Place Memphis, Tennessee 38132 Telephone: [phone] Fax: [phone]

> Contact: Chris McKee Regulatory Affairs Specialist

- Proposed Proprietary Trade Name: ATLANTIS® Anterior Cervical Plate System II.
- III. Classification Name(s): Metallic Bone Fixation Appliance; Class: II; Product Code(s): K WQ; and Regulation No .: 888.3060
- Legally Marketed Devices: ATLANTIS® Anterior Cervical Plate System (K970806) IV.
- V. Description: The ATLANTIS® Anterior Cervical Plate System components are temporary implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical spinal fusion.

The ATLANTIS® 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 ATLANTIS® Anterior Cervical Plate System implant components are made from titanium alloy, with certain plates having subcomponents manufactured from a superelastic allov (Nitinol-NiT). Stainless steel and titanium implant components must not be used together in a construct.

- VI. Indications for Use: Properly used, this system is intended for anterior interbody screw/plate fixation from C2 to T1. 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.

- VII. Substantial Equivalence: Documentation, including a risk analysis and prior mechanical testing, was provided which demonstrated the subject plates to be substantially equivalent to predicate

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ATLANTIS® Anterior Cervical Plate System plates previously cleared in K970806, K021461 and
K063100 and the C-Tek® MaxAn™ Anterior Cervical Plate System cleared in K080646.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2008

Medtronic Sofamor Danek % Mr. Chris Mckee Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132

Re: K081038

> Trade/Device Name: ATLANTIS® 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: July 24, 2008 Received: July 29, 2008

Dear Mr. McKee:

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 – Mr. Chris McKee

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Mulkerson

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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### July 2008

#### 510(k) Number (if known): K081038

Device Name: _________________________________________________________________________________________________________________________________________________________________

#### Indications for Use

Properly used, this system is intended for anterior interbody screw/plate fixation from C2 to T1. 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) 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.

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)

Barbara Bucheno for mky
Division Sign Off

Division of General, Restorative, and Neurological Devices

510(k) Number K081038