Predicate Devices

K221728 Stryker LITe® Plate System

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on mechanical components (plates, screws, instrumentation) for spinal stabilization and fusion. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies are based on mechanical testing.

Therapeutic

Yes

The device is intended to treat acute and chronic instabilities or deformities of the lumbar and lumbosacral spine, such as degenerative disc disease, spondylolisthesis, and trauma, by providing support during spinal fusion. This directly addresses medical conditions and provides a therapeutic effect.

Diagnostic

No

This device is a lumbar plate system intended to provide additional support during spinal fusion, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system includes plates, screws, and an instrument set, which are physical hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, 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, such as blood, urine, or tissue, to provide information about a person's health.
Device Description: The description clearly states that the Coupler-ATM and Coupler-LTM Lumbar Plate Systems are implants (plates and screws) used for surgical stabilization of the spine during fusion. They are physically inserted into the patient's body.
Intended Use: The intended use is to provide structural support and stabilization to the lumbar spine in skeletally mature patients with various spinal conditions. This is a therapeutic and structural function, not a diagnostic one based on analyzing biological samples.

The device is a surgical implant system, not a diagnostic test performed on samples outside the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Coupler-ATM and Coupler-LTM Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels or via an anterior approach below the bifurcation of the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies):

· Pseudoarthrosis;
· Spondylolysis;
· Spondylolisthesis;
· Spinal stenosis;
Tumors;
· Trauma (i.e. Fractures or Dislocation)
· Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
· Failed Previous Fusion

Product codes (comma separated list FDA assigned to the subject device)

KWQ

Device Description

The Coupler-ATM and Coupler-L™ Lumbar Plate Systems provide stabilization to the lumbar spine during spinal fusion. These systems include plates, screws, and an instrument set used in the surgical insertion of the implants. The implants are composed of Ti6Al4V ELI Titanium 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 the screws into place with cam screws after insertion. The plates are available in multiple lengths to allow for utilization in fusion operations across L1 to S1 of the lumbar spine. The system instrumentation is manufactured from surgical grade stainless steel and other surgical grade materials. The instrumentation is used in the placement and fixing of the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lumbar and lumbosacral (L1-S1) spine

Indicated Patient Age Range

skeletally mature patients

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 performs as well as or better than the chosen acceptance criteria.

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.

K221728 Stryker LITe® Plate System

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

Regulation Number and Section

§ 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.

Summary

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April 12, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food & 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.

Omnia Medical, LLC % Ms. Jennifer Palinchik President JALEX Medical 27865 Clemens Rd Suite 3 Westlake, Ohio 44145

Re: K230424

Trade/Device Name: Omnia Medical Coupler-A™ Anterior Lumbar Plate System: Omnia Medical Coupler-LTM Lateral Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 15, 2023 Received: February 17, 2023

Dear Ms. 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

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) K230424

Device Name

Omnia Medical Coupler-ATM Anterior Lumbar Plate System and Omnia Medical Coupler-L™ Lateral Lumbar Plate System

Indications for Use (Describe)

The Coupler-ATM and Coupler-LTM Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels or via an anterior approach below the bifurcation of the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies):

· Pseudoarthrosis;
· Spondylolysis;
· Spondylolisthesis;
· Spinal stenosis;
Tumors;
· Trauma (i.e. Fractures or Dislocation)
· Deformities (i.e. Scoliosis, Kyphosis or Lordosis)
· 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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Image /page/3/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a circular graphic on the left and the words "Omnia Medical" on the right. The graphic is divided into two sections, with the top section being dark blue and the bottom section being gray. The words "Omnia Medical" are stacked on top of each other, with "Omnia" on top and "Medical" on the bottom. The word "Omnia" is in a larger font size than the word "Medical", and both words are gray.

510(k) Summary

| Submitted By: | Omnia Medical, LLC
6 Canyon Road Suite 300
Morgantown, WV 26508 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 02/16/2023 |
| Contact Person: | Jennifer Palinchik, President, JALEX Medical |
| Contact Telephone: | (440) 935-3282 |
| Contact Fax: | (440) 933-7839 |
| Contact Address: | JALEX Medical, LLC
27865 Clemens Rd Suite 3
Westlake, Ohio 44145 |
| Device Trade Name: | Omnia Medical Coupler-A TM Anterior Lumbar Plate System and
Omnia Medical Coupler-L TM Lateral Lumbar Plate System |
| 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: | K221728 Stryker LITe® Plate System |
| | The primary predicate device has never been subject to a recall. |

Device Description:

The Coupler-ATM and Coupler-L™ Lumbar Plate Systems provide stabilization to the lumbar spine during spinal fusion. These systems include plates, screws, and an instrument set used in the surgical insertion of the implants. The implants are composed of Ti6Al4V ELI Titanium 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 the screws into place with cam screws after insertion. The plates are available in multiple lengths to allow for utilization in fusion operations across L1 to S1 of the lumbar spine. The system instrumentation is manufactured from surgical grade stainless steel and other surgical grade materials. The instrumentation is used in the placement and fixing of the device.

Indications for Use:

The Coupler-ATM and Coupler-L™ Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities:

· Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies);
· Pseudoarthrosis:
· Spondylolysis;
· Spondylolisthesis;
· Spinal stenosis;
· Tumors;
· Trauma (i.e. Fractures or Dislocation)

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Image /page/4/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray circular graphic on the left, with the text "Omnia" in blue and "Medical" in gray on the right. The graphic appears to be a stylized wave or mountain range.

Deformities osis, Kyphosis or Lordosis)
Failed Previous Fusion

Summary of Technological Characteristics:

The Omnia Medical Coupler-A™ Anterior Lumbar Plate System, Omnia Medical Coupler-L™ Lateral Lumbar Plate System and the predicate have the same intended use and fundamental scientific technology. All devices compare similarly in:

Design features
Intended use
Materials
Dimensions ●
Function ●

Table 8.1: Dimensions and Technological Characteristics Comparison Lumbar Plate Systems
Item	Omnia Medical Coupler-A™ and
Coupler-L™ Lumbar Plate Systems	Stryker LITe® Plate
System
(K221728)	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 Coupler-A™ and Coupler-L™
Lumbar Plate Systems are indicated for
use via a lateral or anterolateral surgical
approach above the bifurcation of the
vessels or via an anterior approach
below the bifurcation of the great
vessels in the treatment of lumbar and
lumbosacral (L1-S1) spine. The system
is intended to provide additional support
during fusion in skeletally mature
patients in the treatment of the following
acute and chronic instabilities or
deformities:
Degenerative Disc Disease (defined
as back pain of discogenic origin
with degeneration of the disc
confirmed by patient history and
radiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Spinal stenosis; Tumors; Trauma (i.e. Fractures or
Dislocation) Deformities (i.e. Scoliosis, Kyphosis
or Lordosis)	The LITe® Plate
Universal, Sacral, 2 Screw
and 4 Screw Plates are
indicated for use via a
lateral or anterolateral
surgical approach above
the bifurcation of the
vessels in the treatment of
the thoracic and
thoracolumbar (T1-L5)
spine or via an anterior
approach below the
bifurcation of the great
vessels in the treatment of
lumbar and lumbosacral
(L1-S1) spine. The system
is intended to provide
additional support during
fusion in skeletally mature
patients in the treatment of
the following acute and
chronic instabilities or
deformities:
Degenerative Disc
Disease (defined as
back pain of discogenic
origin with
degeneration of the disc	Equivalent

	• Failed Previous Fusion	confirmed by patient
history and
radiographic studies);
• Pseudoarthrosis;
• Spondylolysis;
• Spondylolisthesis;
• Spinal stenosis;
• Tumors;
• Trauma (i.e. Fractures
or Dislocation)
• Deformities (i.e.
Scoliosis, Kyphosis or
Lordosis)
• Failed Previous Fusion
Description	The Coupler-ATM and Coupler-LTM
Lumbar Plate Systems provide
stabilization to the lumbar spine during
spinal fusion. These systems include
plates, screws, and an instrument set
used in the surgical insertion of the
implants. The implants are composed of
Ti6Al4V ELI Titanium 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
the screws into place with cam screws
after insertion. The plates are available
in multiple lengths and levels to allow
for utilization in fusion operations
across L1 to S1 of the lumbar spine. The
system instrumentation is manufactured
from surgical grade stainless steel and
other surgical grade materials. The
instrumentation is used in the placement
and fixing of the device.	The previously cleared
devices consist of a variety
of plate systems designed
to provide support across
implanted levels in the
cervical, thoracolumbar,
and lumbosacral spine until
fusion is achieved.	Equivalent
Plate Sizes-
Anterior	Anterior Lumbar Plate, L1-L5, 30mm-
40mm Length, 21mm Width
Anterior Lumbar Plate, L5-S1, 30mm-
40mm Length, 21mm Width	21-37mm 1 Level
Universal Plate, 26mm
Width
21-37mm 1 Level Sacral
Plate, 21/26mm Widths	Equivalent
Plate
Thickness-
Anterior	3.75mm	3.5mm Universal Plates
4.0mm Sacral Plates	Equivalent
Plate Sizes-
Lateral	Lateral Lumbar Plate, L1 – L5, 30mm-
40mm Length, 18mm Width	2-Screw Lateral:
Length - 16mm-28mm
Width – 17 mm
4-Screw Lateral:
Length - 18mm-28mm	Equivalent
		Width – 21mm
Plate Thickness-Lateral	3.75mm	2-Screw Lateral – 4.5 mm
4-Screw Lateral – 4.5 mm	Equivalent
Screw sizes	5.5mm and 6.0mm diameters, varying lengths	5.0mm and 5.5mm diameters, varying lengths	Equivalent
Material	Ti6A14V per ASTM F136	Ti6A14V	Equivalent

Table 8 1: Dimensions and Technological Characteristics Comparison Lumbar Plate Systems

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Image /page/6/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray abstract wave-like design on the left, followed by the words "Omnia" in blue and "Medical" in gray on the right. The text is in a simple, sans-serif font.

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 performs as well as or better than the chosen acceptance criteria.

Conclusion:

Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.