NEXUS ANTERIOR CERVICAL PLATE SYSTEM

K131520 · Core-Nexus · KWQ · Jul 11, 2013 · Orthopedic

Device Facts

• Record ID: K131520
• Device Name: NEXUS ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Core-Nexus
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 11, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nexus Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Nexus Anterior Cervical Plate System is a spinal fixation implant system consisting of main plates, screws, sub-plates, and rivets. Designed for anterior cervical spine stabilization. Sub-plates are pre-assembled to main plates to prevent screw back-out via elastic behavior during insertion. Components are color-anodized for identification. Plates support one- to four-level procedures; lengths 20mm-110mm. Screws (3.5mm/4.0mm diameter) available in fixed/variable, self-tapping/self-drilling configurations. Used by surgeons in clinical settings to provide structural support for spinal fusion. Benefits include stabilization of the cervical spine in patients with degenerative, traumatic, or deformity-related conditions.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Titanium alloy (Ti-6AI-4V ELI) per ASTM F136. Components: main plates, screws, sub-plates, rivets. Screw diameters: 3.5mm/4.0mm. Screw lengths: 10mm-20mm. Plate lengths: 20mm-110mm. Non-sterile, single-use. Mechanical fixation via screw-plate-rivet assembly with anti-back-out sub-plate mechanism.

Indications for Use

Indicated for anterior cervical spine fixation in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

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

• Dio Medical Rex Anterior Cervical Plate System (K121862)

Submission Summary (Full Text)

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## 510(k) Summary Nexus Anterior Cervical Plate System

| SUBMITTED BY | Core-Nexus<br>15760 Ventura Blvd<br>7th Floor<br>Encino, CA 91436 | JUL 1 1 2013 |
|------------------------------------------|---------------------------------------------------------------------------------------------------------|--------------|
| ESTABLISHMENT<br>REGISTRATION NUMBER | Pending | |
| OWNER/OPERATOR<br>NUMBER | Pending | |
| CONTACT PERSON | Thomas Palmer<br>President<br>Core-Nexus<br>Email: [e-mail]<br>Phone: [phone] | |
| SUBMISSION PREPARED BY | Lisa Peterson<br>Kaedon Consulting, LLC<br>Email: [e-mail]<br>Phone: [phone] | |
| DATE PREPARED | May 15, 2013 | |
| CLASSIFICATION NAME | Spinal Intervertebral Body Fixation Orthosis | |
| DEVICE CLASS | Class II | |
| REGULATION NUMBER | 888.3060 (Product Code KWQ) | |
| COMMON NAME | Anterior Cervical Plate System | |
| PROPRIETARY NAME | Nexus Anterior Cervical Plate System | |
| IDENTIFICATION OF PREDICATE<br>DEVICE(S) | Dio Medical Rex Anterior Cervical Plate System (K121862) | |

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### DEVICE DESCRIPTION

The Nexus Anterior Cervical Plate System consists of a variety of shapes and sizes of main plates, screws, sub-plates, rivets and associated instruments. The sub-plate is pre-assembled to the main plate and designed to prevent screws from backing out using the elastic behavior during the screw insertion.

The rivets are pre-assembled to the main plate, which firmly attach the sub-plate component to the main plate. Each component is color anodized to differentiate the screw type and diameter and to facilitate the surgical process.

The plates range in length to accommodate one, two, three, and four level procedures. Main plates are available from 20mm to 110mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 3.5mm or 4.0mm diameter. They are provided in fixed self-tapping, variable self-tapping, fixed self-drilling and variable self-drilling configurations.

#### INDICATIONS

The Nexus Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The purpose of this Special 510(k) is to obtain clearance to market the subject device as the Nexus Anterior Cervical Plate System. The subject device was previously cleared as the Dio Medical Rex Anterior Cervical Plate System (K121862). Documentation the legal right to distribute the Nexus Anterior Cervical Plate System is maintained at Core-Nexus.

The subject device is identical to the previously cleared Rex System in terms of indications for use, device dimensions instrumentation, manufacturing process, cleaning/sterilization process and labeling. The System implant components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.

#### DISCUSSION OF NON-CLINICAL TESTING

Non-clinical testing was not performed as part of this submission.

#### CONCLUSIONS

The subject device is identical to the predicate device in terms of indications for use, device dimensions, instrumentation, manufacturing process, cleaning/sterilization process and labeling. Documentation was provided as part of this Special 510(k) to demonstrate that the Nexus Anterior Cervical Plate System is substantially equivalent to the 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of flowing lines. The logo is black and white.

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

July 11, 2013

Core-Nexus % Mr. Thomas Palmer President 15760 Ventura Boulevard, 7th Floor Encino, California 91436

Re: K131520

Trade/Device Name: Nexus 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: June 10, 2013 Received: June 13, 2013

Dear Mr. Palmer:

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 - Mr. Thomas Palmer

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 Dreith

For

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

Enclosure

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#### INDICATIONS FOR USE

9

K131520 510(k) Number (if known):

#### Device Name: Nexus Anterior Cervical Plate System

Indications for Use:

The Nexus Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The specific clinical indications include:

degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use AND/OR Over-The-Counter Use × (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices 3