(212 days)
No
The summary describes a mechanical spinal implant system and its materials, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is described as a "spinal intervertebral body fixation orthosis" intended to provide "temporary immobilization of the anterior spine during the development of cervical spine fusions". While it aids in a medical treatment (fusion), it is an orthopedic implant for mechanical support, not a device that directly administers therapy or performs a therapeutic function itself (like drug delivery, radiation, or nerve stimulation).
No
The device is a spinal intervertebral body fixation orthosis used for temporary immobilization and structural stability of the anterior spine following cervical discectomy and fusion, which is a treatment and stabilization function, not a diagnostic one.
No
The device description explicitly states it consists of implants manufactured from metal alloys and instrumentation manufactured from stainless steel, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "spinal intervertebral body fixation orthosis" intended to provide "temporary immobilization of the anterior spine during the development of cervical spine fusions." This describes a surgical implant used to stabilize the spine.
- Device Description: The description details the materials and components of a surgical implant (plates and screws) and associated instrumentation.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with bodily specimens in this way.
The information provided describes a Class II or Class III medical device used in surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization of the anterior spine during the development of cervical spine fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain with degeneration of disc confirmed by patient history and radiographic studies); (2) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis); (6) Tumors: (7) Pseudoarthrosis: (8) Failed previous fusions.
Product codes
KWQ
Device Description
The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis used to provide structural stability following anterior cervical discectomy and fusion for cervical degenerative disorders.
The CYGNUS™ MoRe Anterior Cervical Plate System consists of implants manufactured from Wrought Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The system is offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior spine, cervical spine (C2 to C7)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The mechanical performance profile of CYGNUS™ MoRe Anterior Cervical Plate System was assessed through static and dynamic construct testing in accordance with the following test methods:
- .Static compression bending (ASTM F1717-21)
- Static torsion testing (ASTM F1717-21)
- Dynamic compression bending (ASTM F1717-21) ●
Bacterial endotoxin testing was performed per ANSI/AAMI ST72:2011 using the limulus amebocyte lysate (LAL) pyrogen testing.
Performance data demonstrate that the CYGNUS™ MoRe Anterior Cervical Plate System is substantially equivalent to legally marketed predicate systems.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
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.(b)
Classification. Class II.
0
September 16, 2022
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
MiRus, LLC Jordan Bauman Vice President, Regulatory Affairs 1755 West Oak Parkway, Suite 100 Marietta. Georgia 30062
Re: K220441
Trade/Device Name: CYGNUS™ MoRe 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: August 17, 2022 Received: August 17, 2022
Dear Jordan 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K220441
Device Name
CYGNUS™ MoRe Anterior Cervical Plate System
Indications for Use (Describe)
The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization of the anterior spine during the development of cervical spine fusions (C2 to C7) in patients with: (1) Degenerative disc disease, DDD (as defined by neck pain with degeneration of disc confirmed by patient history and radiographic studies); (2) Trauma (including fractures or dislocations); (4) Spinal cord stenosis; (5) Deformity or curvatures (i.e. kyphosis, lordosis); (6) Tumors: (7) Pseudoarthrosis: (8) Failed previous fusions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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
1755 West Oak Parkway
Suite 100
Marietta, Georgia 30062
Tel: (678) 324-6272
Fax: (678) 401-5607 |
|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| II. OFFICIAL
CORRESPONDENT | Jordan Bauman
Vice President, Regulatory Affairs
MiRus™, LLC
1755 West Oak Parkway
Suite 100
Marietta, Georgia 30062
Tel: (678) 324-6272
Fax: (678) 401-5607 |
| III. DATE PREPARED | August 15, 2022 |
| IV. DEVICE
Name of Device
Common Name
Classification Name
Regulatory Class
Product Codes
Submission Type | CYGNUS™ MoRe Anterior Cervical Plate System
Spinal intervertebral body fixation orthosis
21 CFR 888.3060
Class II
KWQ
Traditional 510(k) |
| V. PREDICATE DEVICE | Primary Predicate
CYGNUS™ Anterior Cervical Plate System – MiRus, LLC
(K190666)
Reference Device
ATLAS™ Plating System (K191867) |
VI. DEVICE DESCRIPTION
The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis used to provide structural stability following anterior cervical discectomy and fusion for cervical degenerative disorders.
The CYGNUS™ MoRe Anterior Cervical Plate System consists of implants manufactured from Wrought Molybdenum-47.5 Rhenium Alloy (MoRe) per ASTM F3273, Titanium-6 Vanadium ELI per ASTM F136, and instrumentation manufactured from Stainless Steel per ASTM F899. The system is offered in several configurations of various sizes to accommodate different patient anatomy and surgical approaches.
4
VII. INDICATIONS FOR USE
The CYGNUS™ MoRe Anterior Cervical Plate System is a spinal intervertebral body fixation orthosis which is intended to provide temporary immobilization of the anterior spine during the development of cervical spine 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) Pseudoarthrosis; (8) Failed previous fusions.
VIII. PREDICATE DEVICE COMPARISON
The CYGNUS™ MoRe Anterior Cervical Plate System has the same technological characteristics as the predicate devices including design, intended use, function, and range of sizes. The predicate device components are manufactured from titanium alloys (ASTM F136 and F2066). The CYGNUS™ MoRe Anterior Cervical Plate System components are manufactured from titanium alloy (ASTM F136) and molybdenum-rhenium alloy (ASTM F3273), which are the same materials as the reference device.
IX. PERFORMANCE DATA
The mechanical performance profile of CYGNUS™ MoRe Anterior Cervical Plate System was assessed through static and dynamic construct testing in accordance with the following test methods:
- . Static compression bending (ASTM F1717-21)
- Static torsion testing (ASTM F1717-21)
- Dynamic compression bending (ASTM F1717-21) ●
Bacterial endotoxin testing was performed per ANSI/AAMI ST72:2011 using the limulus amebocyte lysate (LAL) pyrogen testing.
X. CONCLUSIONS
The CYGNUS™ MoRe Anterior Cervical Plate System has the same intended use, indications for use, labeling, and technological characteristics as the predicate systems, including the same design features, geometries, sizes, and materials. Performance data demonstrate that the CYGNUS™ MoRe Anterior Cervical Plate System is substantially equivalent to legally marketed predicate systems.