(133 days)
Not Found
No
The device description and performance studies focus on mechanical properties and surgical instrumentation, with no mention of AI/ML or related concepts.
No.
The device is an implantable plate system used for stabilizing the spine during fusion, which is a structural support rather than a direct therapeutic agent or device that treats a disease through non-structural means.
No
The device is an anterior cervical plate system used to stabilize the spine during fusion, not to diagnose a condition.
No
The device description explicitly details physical components like plates, screws, and instruments made of titanium and stainless steel, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The Omnia Medical Coupler-C Anterior Cervical Plate is an implantable device used to stabilize the spine within the body during surgery. It is a physical structure, not a test or analysis tool.
- Intended Use: The intended use is to provide temporary stabilization of the spine, which is a surgical intervention, not a diagnostic test.
The information provided clearly describes a surgical implant and its associated instrumentation, which falls under the category of a medical device used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Omnia Medical Coupler-C Anterior Cervical Plate is indicated for use in temporarily stabilizing the anterior spine from C2 to T1 during the development of cervical spinal fusion in patients with degenerative disc disease (DD, 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 (i.e., scoliosis, kyphosis, and/or lordosis), tumors, pseudoarthrosis, or failed previous fusion.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The Omnia Medical Coupler-C Anterior Cervical Plate system includes plates, screws, and an instrument set used to insert the implants. The implants are composed of Ti-6Al-4V ELI per ASTM F136. The screws are inserted into the vertebral body through corresponding holes in the plate to achieve fixation. A screw locking system is incorporated in the plate, allowing the surgeon to lock screws into place with anti-backout mechanisms after insertion. The plates are available in multiple lengths and levels to allow for utilization in fusion operations across 1 to 4 levels of the cervical spine. The system instrumentation is manufactured from surgical grade stainless steel (17-4 PH per ASTM F899) and other surgical grade materials. The instrumentation is used to prepare the site and to implant the device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, C2 to T1
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical Testing: Substantial equivalence is supported by the results of mechanical testing, including static and dynamic compression bending, and static torsion per ASTM F1717. Results support that the subject device has demonstrated substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K143626, K113329, K183056, K182489
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
March 13, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Omnia Medical, LLC % Jennifer Palinchik President Jalex Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145
Re: K223321
Trade/Device Name: Omnia Medical Coupler-C Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 17, 2023 Received: January 19, 2023
Dear Jennifer Palinchik:
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
1
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 -S FDA
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) K223321
Device Name Omnia Medical Coupler-C Anterior Cervical Plate
Indications for Use (Describe)
The Omnia Medical Coupler-C Anterior Cervical Plate is indicated for use in temporarily stabilizing the anterior spine from C2 to T1 during the development of cervical spinal fusion in patients with degenerative disc disease (DD), 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 (i.e., scoliosis, kyphosis, and/or lordosis), tumors, pseudoarthrosis, or failed previous fusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CER 801 Subpart D) | |
| □ Over-The-Counter Use (21 CER 801 Subpart C) |
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3
510(k) Summary
| Submitted By: | Omnia Medical, LLC
6 Canyon Road Suite 300
Morgantown, WV 26508 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 01/17/2023 |
| Contact Person: | Jennifer Palinchik, President |
| Contact Telephone: | (440) 935-3282 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Omnia Medical Coupler-C Anterior Cervical Plate |
| Common Name: | Spinal Intervertebral Body Fixation Orthosis |
| Device Classification Name: | Spinal Intervertebral Body Fixation Orthosis (21 CFR 888.3060) |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | KWQ |
| Primary Predicate Device: | K143626- Zimmer Spine Invizia Anterior Cervical Plate System
The primary predicate device has never been subject to a recall. |
| Additional Predicates: | K113329 K2M Pyrenees Cervical Plate System
K183056 Globus ASSURE Anterior Cervical Plate System
K182489 Solco 4CIS® Pinehurst Anterior Cervical Plate System |
Device Description:
The Omnia Medical Coupler-C Anterior Cervical Plate system includes plates, screws, and an instrument set used to insert the implants. The implants are composed of Ti-6Al-4V ELI per ASTM F136. The screws are inserted into the vertebral body through corresponding holes in the plate to achieve fixation. A screw locking system is incorporated in the plate, allowing the surgeon to lock screws into place with anti-backout mechanisms after insertion. The plates are available in multiple lengths and levels to allow for utilization in fusion operations across 1 to 4 levels of the cervical spine. The system instrumentation is manufactured from surgical grade stainless steel (17-4 PH per ASTM F899) and other surgical grade materials. The instrumentation is used to prepare the site and to implant the device.
Indications for Use:
The Ommia Medical Coupler-C Anterior Cervical Plate is indicated for use in temporarily stabilizing the anterior spine from C2 to T1 during the development of cervical spinal fusion in patients with degenerative disc disease (DDD, 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), tumors, pseudoarthrosis, or failed previous fusion.
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Summary of Technological Characteristics:
The Omnia Medical Coupler-C Anterior Cervical Plate and the predicate have the same intended use and fundamental scientific technology. All devices compare similarly in:
- Design features
- Intended use ●
- Materials .
- Dimensions
- Function ●
| Item | Omnia Coupler Cervical Plate | Zimmer InViZia Cervical
Plate (K143626) | Comparison |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Classification
Name | Spinal Intervertebral Body Fixation
Orthosis | Spinal Intervertebral Body
Fixation Orthosis | Equivalent |
| Regulation | 21 CFR 888.3060 | 21 CFR 888.3060 | Equivalent |
| Product Code | KWQ | KWQ | Equivalent |
| Indications
for Use | The Omnia Medical Coupler-C Anterior
Cervical Plate is in indicated for use in
temporarily stabilizing the anterior spine
from C2 to T1 during the development
of cervical spinal fusion in patients with
degenerative disc disease (DDD, 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), tumors,
pseudoarthrosis, or failed previous
fusion. | The inViZia® Anterior
Cervical Plate System is
designed for anterior
interbody
screw fixation of the
cervical spine at levels C2-
T1.
The inViZia® Anterior
Cervical Plate System is
indicated for use in the
temporary
stabilization of the anterior
spine during the
development of cervical
spinal fusions in patients
with 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),
pseudoarthrosis and/or
failed previous fusions. | Equivalent |
| Description | The Omnia Medical Coupler-C Anterior
Cervical Plate system includes plates | The Zimmer Spine
Anterior Cervical and | Equivalent |
| | | | |
| | in the surgical insertion of the implants.
The implants are composed of Ti-6Al-4V ELI per ASTM F136. The screws are inserted into the vertebral body through corresponding holes in the plate in order to achieve fixation. A screw locking system is incorporated in the plate, allowing the surgeon to lock screws into place with anti-backout mechanisms after insertion. The plates are available in multiple lengths and levels to allow for utilization in fusion operations across 1 to 4 levels of the cervical spine. The system instrumentation is manufactured from surgical grade stainless steel (17-4 PH per ASTM F899) and other surgical grade materials. The instrumentation is used to prepare the site and in placement of the device. | Lumbar Plate Systems are intended to provide stabilization of the spine during the development of a solid spinal fusion in patients per the system(s) indications at various spinal levels. The Zimmer Spine Anterior Cervical and Lumbar Plate Systems consist of plates, bone screws and instruments necessary to implant the specific system. Bone screws are secured to the plate through locking caps and/or a Secure Ring® mechanism. The plates are available in various sizes and lengths and the bone screws are available in various diameters and lengths. | |
| Plate Sizes | 1 Level: 21-33mm, 2mm increments
2 Level: 33-55mm, 2mm increments
3 Level: 51-78mm, 3mm increments
4 Level: 73-105mm, 4mm increments | 1 Level: 18-34mm, 2mm increments
2 Level: 34-54mm, 2mm increments
3 Level: 48-72mm, 3 mm increments
4 Level: 68-92mm, 4mm increments | Equivalent |
| Plate length
(hole-to-hole) | 1 Level: 12-24mm, 2mm increments
2 Level: 24-36mm, 2mm and 3mm increments
3 Level: 42-69mm, 3mm increments
4 Level: 64-96mm, 4mm increments | NA | Equivalent |
| Plate
Thickness | 2mm |