Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System

{0}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) | | |---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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<br>6 Canyon Road Suite 300<br>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<br>27865 Clemens Rd Suite 3<br>Westlake, Ohio 44145 | | Device Trade Name: | Omnia Medical Coupler-A ^TM Anterior Lumbar Plate System and<br>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) {4}------------------------------------------------ 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<br>Coupler-L™ Lumbar Plate Systems | Stryker LITe® Plate<br>System<br>(K221728) | Comparison | | Classification<br>Name | Spinal Intervertebral Body Fixation<br>Orthosis | Spinal Intervertebral Body<br>Fixation Orthosis | Equivalent | | Regulation | 21 CFR 888.3060 | 21 CFR 888.3060 | Equivalent | | Product Code | KWQ | KWQ | Equivalent | | Indications<br>for Use | The Coupler-A™ and Coupler-L™<br>Lumbar Plate Systems are indicated for<br>use via a lateral or anterolateral surgical<br>approach above the bifurcation of the<br>vessels or via an anterior approach<br>below the bifurcation of the great<br>vessels in the treatment of lumbar and<br>lumbosacral (L1-S1) spine. The system<br>is intended to provide additional support<br>during fusion in skeletally mature<br>patients in the treatment of the following<br>acute and chronic instabilities or<br>deformities:<br>Degenerative Disc Disease (defined<br>as back pain of discogenic origin<br>with degeneration of the disc<br>confirmed by patient history and<br>radiographic studies); Pseudoarthrosis; Spondylolysis; Spondylolisthesis; Spinal stenosis; Tumors; Trauma (i.e. Fractures or<br>Dislocation) Deformities (i.e. Scoliosis, Kyphosis<br>or Lordosis) | The LITe® Plate<br>Universal, Sacral, 2 Screw<br>and 4 Screw Plates are<br>indicated for use via a<br>lateral or anterolateral<br>surgical approach above<br>the bifurcation of the<br>vessels in the treatment of<br>the thoracic and<br>thoracolumbar (T1-L5)<br>spine or via an anterior<br>approach below the<br>bifurcation of the great<br>vessels in the treatment of<br>lumbar and lumbosacral<br>(L1-S1) spine. The system<br>is intended to provide<br>additional support during<br>fusion in skeletally mature<br>patients in the treatment of<br>the following acute and<br>chronic instabilities or<br>deformities:<br>Degenerative Disc<br>Disease (defined as<br>back pain of discogenic<br>origin with<br>degeneration of the disc | Equivalent | | | | | | | | • Failed Previous Fusion | confirmed by patient<br>history and<br>radiographic studies);<br>• Pseudoarthrosis;<br>• Spondylolysis;<br>• Spondylolisthesis;<br>• Spinal stenosis;<br>• Tumors;<br>• Trauma (i.e. Fractures<br>or Dislocation)<br>• Deformities (i.e.<br>Scoliosis, Kyphosis or<br>Lordosis)<br>• Failed Previous Fusion | | | Description | The Coupler-ATM and Coupler-LTM<br>Lumbar Plate Systems provide<br>stabilization to the lumbar spine during<br>spinal fusion. These systems include<br>plates, screws, and an instrument set<br>used in the surgical insertion of the<br>implants. The implants are composed of<br>Ti6Al4V ELI Titanium per ASTM<br>F136. The screws are inserted into the<br>vertebral body through corresponding<br>holes in the plate to achieve fixation. A<br>screw locking system is incorporated in<br>the plate allowing the surgeon to lock<br>the screws into place with cam screws<br>after insertion. The plates are available<br>in multiple lengths and levels to allow<br>for utilization in fusion operations<br>across L1 to S1 of the lumbar spine. The<br>system instrumentation is manufactured<br>from surgical grade stainless steel and<br>other surgical grade materials. The<br>instrumentation is used in the placement<br>and fixing of the device. | The previously cleared<br>devices consist of a variety<br>of plate systems designed<br>to provide support across<br>implanted levels in the<br>cervical, thoracolumbar,<br>and lumbosacral spine until<br>fusion is achieved. | Equivalent | | Plate Sizes-<br>Anterior | Anterior Lumbar Plate, L1-L5, 30mm-<br>40mm Length, 21mm Width<br>Anterior Lumbar Plate, L5-S1, 30mm-<br>40mm Length, 21mm Width | 21-37mm 1 Level<br>Universal Plate, 26mm<br>Width<br>21-37mm 1 Level Sacral<br>Plate, 21/26mm Widths | Equivalent | | Plate<br>Thickness-<br>Anterior | 3.75mm | 3.5mm Universal Plates<br>4.0mm Sacral Plates | Equivalent | | Plate Sizes-<br>Lateral | Lateral Lumbar Plate, L1 – L5, 30mm-<br>40mm Length, 18mm Width | 2-Screw Lateral:<br>Length - 16mm-28mm<br>Width – 17 mm<br>4-Screw Lateral:<br>Length - 18mm-28mm | Equivalent | | | | Width – 21mm | | | Plate Thickness-Lateral | 3.75mm | 2-Screw Lateral – 4.5 mm<br>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 {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a stylized wave-like graphic in navy blue and gray, followed by the words "Omnia Medical" in a serif font. The word "Omnia" is in navy blue, and the word "Medical" is in gray. {6}------------------------------------------------ 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.