ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM

K130640 · Medtronic Sofamor Danek USA, Inc. · KWQ · Jun 4, 2013 · Orthopedic

Device Facts

• Record ID: K130640
• Device Name: ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 4, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ATLANTIS® Anterior Cervical plate system is intended for anterior interbody screw fixation from C2 to T1 in 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: 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) pseudoathrosis. 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.

Device Story

ATLANTIS® Anterior Cervical Plate System consists of titanium alloy plates and bone screws; used for anterior interbody screw fixation in cervical spine (C2-T1). Device provides temporary stabilization during spinal fusion procedures. Operated by surgeons in clinical/OR settings. Output is mechanical fixation of vertebral bodies. Benefits include stabilization of spine to facilitate fusion in patients with degenerative disease, trauma, tumors, or deformity. Subject of this submission is the provision of these components in sterile packaging.

Clinical Evidence

No clinical data. Bench testing only, specifically focusing on sterilization validation and package integrity for the sterile-provided components.

Technological Characteristics

Titanium alloy plates and screws; anterior cervical fixation; sterile packaging; 8-year shelf life. No software or electronic components.

Indications for Use

Indicated for temporary stabilization of the anterior cervical spine (C2-T1) during fusion in patients with degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, 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 (K021461)
• ATLANTIS® Anterior Cervical Plate System (K081038)

Submission Summary (Full Text)

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# 510(k) Summary

# MEDTRONIC Sofamor Danek ATLANTIS® Anterior Cervical Plate System March 8, 2013

# JUN 0 4 2013

| I. Company: | Medtronic Sofamor Danek, USA Inc.<br>1800 Pyramid Place<br>Memphis, Tennessee 38132<br>[phone] |
|---------------------------------------|-------------------------------------------------------------------------------------------------------|
| II. Contact: | Kristi Frisch<br>Regulatory Affairs Specialist<br>Telephone: [phone]<br>Fax: [phone] |
| III. Proposed Proprietary Trade Name: | ATLANTIS® Anterior<br>Cervical Plate System |
| IV. Classification Names:<br>Class: | Spinal Intervertebral<br>Body Fixation Orthosis<br>II |

#### V. Description:

Product Code:

The ATLANTIS® Anterior Cervical Plate System is intended for the anterior screw fixation from C2 to T1 in the cervical spine. The device is manufactured from titanium alloy. Stainless steel and titanium implant components must not be used together in a construct.

KWQ (21 CFR 888.3060)

The ATLANTIS® Anterior Cervical Plate System consists of plates of various lengths and screws. 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 is to be used with cleared cervical supplemental instrumentation.

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#### VI. Indications for Use:

The ATLANTIS® Anterior Cervical Plate System is intended for anterior interbody screw fixation from C2-T1 in 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: 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) pseudoathrosis, 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. Summary of the Technological Characteristics:

The purpose of this 510(k) submission is to seek clearance for subject parts which are provided sterile.

#### VIII. Identification of Legally Marketed Devices:

The design features and indications for use for the sterile subject are substantially equivalent to the predicate ATLANTIS® Anterior Cervical Plate System (K021461, S.E. 07/22/2002 and K081038, S.E. 08/15/2008)

#### IX. Discussion of Non-Clinical Testing:

Sterilization assessments were completed for the sterile subject plates and screws. These reports provide adequate evidence for the validated sterilization parameters. Shelf life rationales show sterile subject device package integrity with an eight year shelf life.

#### X. Conclusion:

Based on the sterilization and packaging rationales and other supporting documentation provided in this pre-market notification, Medtronic believes that the sterile subject device demonstrates substantial equivalence to the listed predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, a symbol often associated with medicine and healthcare, alongside the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular fashion around the caduceus symbol. The logo is simple and monochromatic.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 4, 2013

Medtronic Sofamor Danek USA, Incorporated % Ms. Kristi Frisch Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132

Re: K130640

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: April 5, 2013 Received: April 8, 2013

Dear Ms. Frisch:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Kristi Frisch

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Erin.D.Keith
For.

Mark N. Melkerson Director Division of Orthopedic Devices Office of-Device-Evaluation-Center for Devices and Radiological Health

Enclosure

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5 I 0(k) Number (if known):

K130640 Page 1 of 1

Device Name: ATLANTIS® Anterior Cervical Plate System

## Indications for Use:

The ATLANTIS ® Anterior Cervical plate system is intended for anterior interbody screw fixation from C2 to T1 in 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: 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) pseudoathrosis. 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)

Anton E. Dmitriev, PhD Division of Orthopedic Devices