(21 days)
The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is interior fixation to the cervical spine C2-C7. The specific clinical indications include:
- degenerative 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.
The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for IMPEACE-UNI and one, two, three, and four level procedures for IMPEACE. Main plate is available from 13mm to 46mm for IMPEACE-UNI and 10mm to 112mm for IMPEACE. Screws are available in lengths from 12mm to 20mm for IMPEACE-UNI and 10mm to 20mm in 2mm increments for IMPEACE. The screws have either a 4.5mm or 5.1mm diameter for IMPEACE-UNI and 4.0mm or 4.5mm diameter for IMPEACE. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium allow (Ti-6Al-4V ELI) that conforms to ASTM F136.
This document is a 510(k) premarket notification for the IMPEACE and IMPEACE-Uni Anterior Cervical Plate System. It explicitly states that no performance testing was required for this submission. The basis for substantial equivalence is that the subject device is identical to a previously cleared predicate device (Huvexel - FORTIS and HANA Anterior Cervical Plate System, K173099).
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details (sample sizes, data provenance, expert panels, adjudication, MRMC studies, standalone performance), or how ground truth was established, as no such studies were conducted or provided in this documentation.
The document states:
- "The subject and predicate devices are identical and therefore, no performance testing is required. Submission is only transferring name of a system that has already been cleared under K173099. No testing is required."
- "The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is identical to the predicate device and is as safe and effective as the Huvexel - FORTIS and HANA Anterior Cervical Plate System."
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March 3, 2022
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Medynus Inc. % Jeena Mathai President Eerkie Corporation 4027 Runnymeade Dr Collegeville, Pennsylvania 19426
Re: K220379
Trade/Device Name: IMPEACE and IMPEACE-Uni 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: February 9, 2022 Received: February 10, 2022
Dear Jeena Mathai:
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
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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 (OS) 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
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Indications for Use
510(k) Number (if known) K220379
Device Name IMPEACE and IMPEACE-Uni Anterior Cervical Plate System
Indications for Use (Describe)
The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is interior fixation to the cervical spine C2-C7. The specific clinical indications include:
- degenerative 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.
| 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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510(k) SUMMARY
Medynus Inc. IMPEACE and IMPEACE-Uni Anterior Cervical Plate System
| Sponsor: | |
|---|---|
| Manufacturer | Medynus Inc.18 Technology Dr. Ste 109 Irvine, CA 92618Phone: (949) 932-0847Email: davidshin@medynus.com |
| Official Contact | Jeena MathaiEerkie Corporation4027 Runnymeade Dr Collegeville, PA 19426Phone: (760) 521-5870Email: mgsharemg@gmail.com |
| Date Prepared: | February 9, 2022 |
| Device Name: | IMPEACE and IMPEACE-Uni Anterior Cervical Plate System |
| Common Name: | Anterior Cervical Plate System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| ClassificationNumber: | 21 CFR 888.3060 |
| ProductCode/Classification: | KWQ, class II |
| Description: | The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy. The plates range in length to accommodate one and two-level procedures for IMPEACE-UNI and one, two, three, and four level procedures for IMPEACE. Main plate is available from 13mm to 46mm for IMPEACE-UNI and 10mm to 112mm for IMPEACE. Screws are available in lengths from 12mm to 20mm for IMPEACE-UNI and 10mm to 20mm in 2mm increments for IMPEACE. The screws have either a 4.5mm or 5.1mm diameter for IMPEACE-UNI and 4.0mm or 4.5mm diameter for IMPEACE. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium allow (Ti-6Al-4V ELI) that conforms to ASTM F136. |
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| Intended Use: | The IMPEACE and IMPEACE-Uni Anterior Cervical Plate System is intendedfor anterior fixation to the cervical spine C2-C7. The specific clinicalindications include: |
|---|---|
| degenerative disc disease (DDD) (defined as neck pain of discogenic originwith degeneration of the disc confirmed by history and radiographicstudies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinalstenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),tumor, pseudoarthrosis, and failed previous fusion. | |
| Predicate Device: | Huvexel - FORTIS and HANA Anterior Cervical Plate System (K173099) |
| SubstantialEquivalence: | The IMPEACE and IMPEACE-Uni Anterior Cervical Plate Systemis identical to the predicate device and is as safe and effective as theHuvexel - FORTIS and HANA Anterior Cervical Plate System. The Subjectdevice has the same intended uses and similar indications, technologicalcharacteristics, and principles of operation as its predicate device. Thereare no technological differences between the Subject device and itspredicate devices resulting in no new issues of safety or effectiveness.Thus, the Medynus IMPEACE and IMPEACE-Uni Anterior Cervical PlateSystem is identical/substantially equivalent. |
| Performance Data: | The subject and predicate devices are identical and therefore, noperformance testing is required. Submission is only transferring name of asystem that has already been cleared under K173099. No testing isrequired. |
| Conclusion: | The Medynus IMPEACE and IMPEACE-Uni Anterior Cervical Plate Systemhas the same intended uses and similar indications, technologicalcharacteristics, and principles of operation as its predicate device. Thus, thesubject device is identical/substantially equivalent to the predicate device. |
N/A