(278 days)
No
The description focuses on the mechanical properties and materials of a physical implant system for spinal fusion, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is intended for anterior screw fixation of the cervical spine for various medical indications like degenerative disc disease, trauma, tumors, and deformity, which are conditions that require therapeutic intervention.
No
The device is described as an anterior cervical fixation device intended to provide structural stability in the cervical spine as an adjunct to fusion. Its purpose is to treat conditions like degenerative disc disease, trauma, and tumors, but not to diagnose them.
No
The device description explicitly states that the system is comprised of plates, screws, and instruments, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The MONET Anterior Cervical Plate System is a surgical implant used to fix the cervical spine. It is implanted in the body, not used to test samples from the body.
- The intended use describes a surgical procedure and the device's role in providing structural stability. It does not describe any diagnostic testing or analysis of biological samples.
- The device description details the materials and components of a surgical implant and instruments. It does not mention any reagents, assays, or other components typically associated with IVDs.
Therefore, the MONET Anterior Cervical Plate System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MONET Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The MONET Anterior Cervical Plate System is intended to be used as an adjunct to fusion with either the MONET ACIF Cage System or structural allograft or any FDA-cleared Cervical Cage System.
Product codes
KWO
Device Description
The MONET Anterior Cervical Plate System is an anterior cervical fixation device used to provide structural stability in skeletally mature individuals. The system is comprised of plates, screws and instruments to facilitate the installation of the implants.The plates are available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-C7)
Indicated Patient Age Range
skeletally mature individuals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests:
- Static Compression Bending (per ASTM F1717)
- Static Torsion (per ASTM F1717)
- Dynamic Compression Bending (per ASTM F1717)
Clinical Tests:
- N/A
Results of the non-clinical tests indicate that no new issues of safety and effectiveness have been raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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November 9, 2022
Image /page/0/Picture/1 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CTL Medical Corporation % Dhaval Saraiya Regulatory/Quality Consultant Omni Strategic Solutions, LLC 700 Pennsylvania Ave SE 2nd Floor Washington, District of Columbia 20003
Re: K220334
Trade/Device Name: MONET Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: September 27, 2022 Received: September 28, 2022
Dear Dhaval Saraiya:
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
1
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 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 medical devices and radiation-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,
Anne D. Talley -S
for
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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
K220334 Page 1 of 1
510(k) Number (if known)
Device Name MONET Anterior Cervical Plate System
Indications for Use (Describe)
The MONET Anterior Cervical Plate System is intenor screw fixation of the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The MONET Anterior Cervical Plate System is intended to be used as an adjunct to fusion with either the MONET ACIF Cage System or structural allograft or any FDA-cleared Cervical Cage System.
| 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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Image /page/3/Picture/0 description: The image shows the logo for CTL Amedica. The logo features three curved shapes in gray and yellow on the left side. The text "CTL AMEDICA" is on the right side of the logo, with "CTL" in yellow and "AMERICA" in black.
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the MONET™ Anterior Cervical Plate System 510(k) premarket notification.
| Sponsor: | CTL Medical Corporation
Sean Suh
4550 Excel Pkwy
Ste 300
Addison, TX 75001 | | | |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|--------------------------------------------------------------------|----------------------------|
| Contact Person: | Dhaval S.
Omni Strategic Solutions, LLC.
Regulatory/Quality Consultant
Email: omniregsolutions@gmail.com | | | |
| Date: | November 1, 2022 | | | |
| Subject Device:
Predicate Device(s): | Trade Name: MONET™ Anterior Cervical Plate System
Common Name: Anterior Cervical Plate System
Classification Name:
KWQ - Appliance, Fixation, Spinal Intervertebral Body
(21 CFR 888.3060 Spinal intervertebral body fixation
orthosis) | | | |
| | Primary
Predicate: | K142218 | Coalition AGX Plate | Globus Medical
Inc. |
| | Reference
Device: | K182151 | MONET™ ACIF Cage
System with
Supplementary Fixation
Plate | CTL Medical
Corporation |
| | Additional
Predicate: | K081391 | VIP Anterior Cervical Plate
System | Globus Medical
Inc. |
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Image /page/4/Picture/0 description: The image shows the logo for CTL Amedica. The logo features two stylized, curved shapes in yellow and gray on the left side. To the right of the shapes is the text "CTL AMEDICA" in a sans-serif font, with "CTL" in yellow and "AMEDICA" in black.
| Purpose and
| Device Description: | The purpose of this submission is to request clearance for the new MONET Anterior Cervical Plate System. The MONET Anterior Cervical Plate System is an anterior cervical fixation device used to provide structural stability in skeletally mature individuals. The system is comprised of plates, screws and instruments to facilitate the installation of the implants.The plates are available in various heights and widths to fit the anatomical needs of a wide variety of patients. The plates and screws are manufactured from Titanium Alloy per ASTM F136. The instruments are manufactured from Stainless Steel per ASTM F899. Implants and instruments will be provided in non-sterile configuration and will require steam sterilization prior to use. |
|---|---|
| Intended Use and | |
| Indications for Use: | The MONET Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, failed previous fusion, spondylolisthesis, and spinal stenosis. The MONET Anterior Cervical Plate System is intended to be used as an adjunct to fusion with either the MONET ACIF Cage System or structural allograft/autograft or any FDA-cleared Cervical Cage System. |
| Summary of Technological | |
| Characteristics: | The rationale for substantial equivalence is based on consideration |
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended Use: The intended use is similar to the intended use ● cleared in K142218 and K182151.
- Indications for Use: The indications for use are similar to the indications for use cleared in K142218 and K182151.
- . Materials: The MONET Anterior Cervical Plate implants are manufactured from Titanium Alloy per ASTM F136 and instruments are manufactured from Stainless Steel per ASTM F899 which are commonly used materials in orthopedic implants and instruments and similar to materials used in K142218 and K182151.
- Design Features: The design features for the MONET ● Anterior Cervical Plate System implants and instruments are similar to those in currently marketed devices cleared in K142218 and K182151. The design differences have not identified any issues that would impact the safety and effectiveness of the device.
- . Sterilization: The MONET Anterior Cervical Plate System implants and instruments are offered to the user in the nonsterile configuration. The non-sterile implants and
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Image /page/5/Picture/0 description: The image shows the logo for CTL Amedica. The logo features a stylized design with curved shapes in gray and yellow, followed by the text "CTL AMEDICA" in a simple, sans-serif font. The "CTL" portion of the text is in yellow, while "AMEDICA" is in gray, matching the colors of the graphic element.
instruments will be required to be steam sterilized by the user prior to use is similar to the devices cleared in K142218 and K182151.
Summary of Performance Data (Nonclinical and/or Clinical):
● Non-Clinical Tests:
- o Static Compression Bending (per ASTM F1717)
- o Static Torsion (per ASTM F1717)
- o Dynamic Compression Bending (per ASTM F1717)
- . Clinical Tests:
- o N/A
Substantial Equivalence Conclusion:
The MONET Anterior Cervical Plate System has shown to be substantially equivalent to the predicate device. Results of the non-clinical tests indicate that no new issues of safety and effectiveness have been raised.