CYGNUS™ Anterior Cervical Plate System

K190666 · MiRus, LLC · KWQ · May 9, 2019 · Orthopedic

Device Facts

• Record ID: K190666
• Device Name: CYGNUS™ Anterior Cervical Plate System
• Applicant: MiRus, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: May 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CYGNUS™ Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the development of cervical spinal fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions.

Device Story

Spinal intervertebral body fixation orthosis; provides temporary immobilization and stabilization of anterior spine during cervical fusion (C2-C7). System consists of titanium alloy plates and screws; used by surgeons in clinical/OR settings. Implants provide mechanical support to stabilize spinal segments; intended to facilitate fusion. Device is non-sterile, single-use. Clinical benefit: stabilization of cervical spine to treat degenerative, traumatic, or deformity-related conditions.

Clinical Evidence

Bench testing only. Static and dynamic compression bending and static torsion testing performed per ASTM F1717-15 to demonstrate mechanical equivalence to predicate devices.

Technological Characteristics

Materials: Commercially Pure Titanium (ASTM F67), Titanium-15 Molybdenum (ASTM F2066), Titanium-6 Aluminum-4 Vanadium ELI (ASTM F136); instrumentation stainless steel (ASTM F899). Form factor: Anterior cervical plate system with various sizes. Non-sterile, single-use. Mechanical testing per ASTM F1717-15.

Indications for Use

Indicated for patients (C2-C7) requiring temporary immobilization/stabilization during cervical spinal fusion for degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), spinal cord stenosis, deformity (kyphosis, lordosis), tumors, pseudarthrosis, or failed previous fusions.

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

• Synthes CSLP System (K000742)
• EBI Anterior Cervical Plate (K001794)
• Aesculap ABC Plate (K974706)

Reference Devices

• MiRus Atlas Plating System (K190415)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 9, 2019

MiRus™, LLC Mr. Jordan Bauman Director of Regulatory Affairs and Quality 2150 Newmarket Parkway SE, Suite 108 Marietta, Georgia 30067

Re: K190666

Trade/Device Name: CYGNUS™ 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: March 13, 2019 Received: March 15, 2019

Dear Mr. Bauman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for CAPT Raquel Peat, PhD, MPH, USPHS Director Office of Health Technology 6 Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K190666

Device Name CYGNUSTM Anterior Cervical Plate System

#### Indications for Use (Describe)

The CYGNUS™ Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the development of cervical spinal fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis); (6) Tumors; (7) Pseudarthrosis; (8) Failed previous fusions.

Type of Use (Select one or both, as applicable):

| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|----------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(c).

| I. SUBMITTER | MiRus™, LLC<br>2150 Newmarket Parkway SE<br>Suite 108<br>Marietta, Georgia 30067<br>Tel: [phone]<br>Fax: [phone] |
|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. OFFICIAL CORRESPONDENT | Jordan Bauman<br>Director of Regulatory Affairs and Quality<br>MiRus™, LLC<br>2150 Newmarket Parkway SE<br>Suite 108<br>Marietta, Georgia 30067<br>Tel: [phone]<br>Fax: [phone] |
| III. DATE PREPARED | March 13, 2019 |
| IV. DEVICE<br>Name of Device<br>Common Name<br>Classification Name<br>Regulatory Class<br>Product Codes<br>Submission Type | CYGNUS™ Anterior Cervical Plate System<br>Spinal Intervertebral Body Fixation Orthosis<br>21 CFR 888.3060<br>Class II<br>KWQ<br>Traditional 510(k) |
| V. PREDICATE DEVICE | Primary:<br>Synthes CSLP System (K000742)<br>Additional:<br>EBI Anterior Cervical Plate (K001794)<br>Aesculap ABC Plate (K974706)<br>Reference: |

MiRus Atlas Plating System (K190415)

## VI. DEVICE DESCRIPTION

The CYGNUS™ Anterior Cervical Plate System consist of implants manufactured from Commercially Pure Titanium per ASTM F67, Titanium-15 Molybdenum per ASTM F2066, and Titanium-6 Aluminum-4 Vanadium ELI per ASTM F136. and instrumentation manufactured from stainless steel per ASTM F899. The Anterior Cervical Plate Devices are offered in four configurations of various sizes to accommodate different patient anatomy. The implants will be provided non-sterile and are intended for single use only.

{4}------------------------------------------------

## VII. INDICATIONS FOR USE

The CYGNUS™ Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization and stabilization of the anterior spine during the development of cervical spinal fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain of discogenic origin with degeneration of disc confirmed by patient history and radiographic studies); (2) Spondylolisthesis; (3) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis and/or scoliosis); (6) Tumors; (7)Pseudarthrosis; (8) Failed previous fusions.

## VIII. PREDICATE DEVICE COMPARISON

The documentation provided shows that the CYGNUS™ Anterior Cervical Plate System is substantially equivalent to the predicate devices in intended use, indications for use, materials, technological characteristics and labeling.

## IX. PERFORMANCE DATA

Static and dynamic compression bending and static torsion were performed adhering to ASTM F1717-15. The preclinical testing listed above that was performed on the CYGNUS™ Anterior Cervical Plate System indicate that it is substantially equivalent to the predicate devices in mechanical performance.

## X. CONCLUSONS

The CYGNUS™ Anterior Cervical Plate System does not raise any new questions of safety or efficacy when compared to the predicate device(s). The CYGNUS™ Anterior Cervical Plate System has demonstrated that it is substantially equivalent in mechanical performance, indications for used, intended use, technological characteristics, materials and labeling to legally marketed predicate devices.