(455 days)
No
The document describes a physical implantable device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is indicated for use in anterior cervical interbody procedures to treat cervical disc disease, which involves alleviating a medical condition.
No
This device is an implantable fusion device used in anterior cervical interbody procedures, designed to aid in spinal fusion, not to diagnose medical conditions.
No
The device description clearly states it is a physical implant made of PEEK and titanium, intended for surgical implantation. It also mentions associated hardware like plates and screws.
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 (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The TiBrid™ SC is a physical implant designed for surgical insertion into the cervical spine to facilitate fusion. It is a structural device, not a testing device.
- Intended Use: The intended use is for anterior cervical interbody fusion procedures, which is a surgical intervention, not a diagnostic test.
The information clearly describes a surgical implant used for treatment, not a device used for laboratory testing of biological samples.
N/A
Intended Use / Indications for Use
The TiBrid™ SC standalone cervical fusion device is indicated for use in anterior cervical interbody procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The device is to be used is patients who have had six weeks of non-operative treatment. The cervical standalone intervertebral body fusion device is to be used with either two bone screws and a screw locking cover or a connecting plate. If the connecting plate is chosen, the number of screws should correspond to the number of holes in the plate.
Product codes (comma separated list FDA assigned to the subject device)
OVE
Device Description
The TiBrid™-SC system consists of a standalone hybrid PEEK OPTIMA™ HA Enhanced and titanium alloy cervical interbody device with 3 titanium plate options (two, three, and four screws) that can be connected to the standalone device. The standalone cages are available in multiple footprints and heights, and have a lordotic angle of 6°. The plates are available in multiple heights. The cages feature a hollow center to accommodate autograft or allograft and include anti-migration features. All devices are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical spine, one level from the C2-C3 disc to the C7-T1 disc.
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 per ASTM F2077, static and dynamic torsion per ASTM F2077, static and dynamic compression shear per ASTM F2077, subsidence per ASTM F2267, and expulsion testing.
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.
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.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
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November 15, 2022
Omnia Medical, LLC Daniel Johnson Project Engineer 6 Canyon Road, Suite 300 Morgantown, West Virginia 26508
Re: K212612
Trade/Device Name: Omnia Medical TiBridTM-SC Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: October 14, 2022 Received: October 17, 2022
Dear Daniel Johnson:
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.
1
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 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 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.
Brent Showalter -S
Brent Showalter, Ph.D. 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) K212612
Device Name Omnia Medical TiBridTM-SC
Indications for Use (Describe)
The TiBrid™ SC standalone cervical fusion device is indicated for use in anterior cervical interbody procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The device is to be used is patients who have had six weeks of non-operative treatment. The cervical standalone intervertebral body fusion device is to be used with either two bone screws and a screw locking cover or a connecting plate. If the connecting plate is chosen, the number of screws should correspond to the number of holes in the plate.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 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 top half of the circle is dark blue, and the bottom half is gray. The word "Omnia" is in dark blue, and the word "Medical" is in gray.
510(k) Summary
| Submitted By: | Omnia Medical, LLC
6 Canyon Road Suite 300
Morgantown, WV 26508 |
|-------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 08/16/2021 |
| Contact Person:
Contact Telephone:
Contact Fax: | Daniel Johnson, Project Engineer
(440) 333-2127
(440) 933-7839 |
| Device Trade Name:
Common Name:
Device Classification Name: | Omnia Medical TiBrid™-SC
Intervertebral Body Fusion Device
Intervertebral Body Fusion Device with Integrated Fixation, Cervical |
| Device Classification:
Reviewing Panel:
Product Code: | Class II
Orthopedic
OVE |
| Primary Predicate Device: | SeaSpine® Shoreline™ ACS – Anterior Cervical Standalone System
(K170569)
The primary predicate device has never been subject to a recall. |
| Reference Devices: | Omnia Medical TiBrid™ Cervical Cage (K190363)
Omnia Medical TiBrid™-SA (K203207)
NuVasive CoRoent Small Interlock System (K192582)
The reference predicate device has never been subject to a recall. |
Device Description:
The TiBrid™-SC system consists of a standalone hybrid PEEK OPTIMA™ HA Enhanced and titanium alloy cervical interbody device with 3 titanium plate options (two, three, and four screws) that can be connected to the standalone device. The standalone cages are available in multiple footprints and heights, and have a lordotic angle of 6°. The plates are available in multiple heights. The cages feature a hollow center to accommodate autograft or allograft and include anti-migration features. All devices are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
Indications for Use:
The TiBrid™-SC standalone cervical intervertebral fusion device is indicated for use in anterior cervical interbody procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. The implants are to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft and implanted via an anterior approach. The device is to be used is patients who have had six weeks of non-operative treatment. The cervical standalone intervertebral body fusion device is to be used with either two bone screws and a screw locking cover or a connecting plate. If the connecting plate is chosen, the number of screws should correspond to the number of holes in the plate.
4
Image /page/4/Picture/1 description: The image contains the logo for Omnia Medical. The logo consists of a stylized wave-like graphic on the left, with the text "Omnia" above the text "Medical" on the right. The wave graphic is split into two colors, with the top portion being a dark blue and the bottom portion being a light gray. The text "Omnia" is also in dark blue, while the text "Medical" is in light gray.
Summary of Technological Characteristics:
The Omnia Medical TiBrid™-SC System and the primary 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 Cervical Plate Systems
| Table 8.1: Dimensions and Technological Characteristics Comparison Cervical Plate Systems | |||||
|---|---|---|---|---|---|
| Item | Omnia Medical | ||||
| TiBrid™-SC | SeaSpine | ||||
| Shoreline™ ACS - | |||||
| Anterior Cervical | |||||
| Standalone System | |||||
| (K170569) | Omnia Medical | ||||
| TiBrid™-C | |||||
| (K190363) | NuVasive CoRoent | ||||
| Small Interlock | |||||
| System (K192582) | Comparison | ||||
| Classification | |||||
| Name | Intervertebral | ||||
| Body Fusion | |||||
| Device with | |||||
| Integrated | |||||
| Fixation, Cervical | Intervertebral Body | ||||
| Fusion Device with | |||||
| Integrated Fixation, | |||||
| Cervical | Intervertebral Fusion | ||||
| Device with Bone | |||||
| Graft, Cervical | Intervertebral Body | ||||
| Fusion Device with | |||||
| Integrated Fixation, | |||||
| Cervical | Equivalent | ||||
| Regulation | 21 CFR 888.3080 | 21 CFR 888.3080 | 21 CFR 888.3080 | 21 CFR 888.3080 | Equivalent |
| Common | |||||
| Name | Intervertebral | ||||
| Body Fusion | |||||
| Device | Intervertebral Body | ||||
| Fusion Device | Intervertebral Body | ||||
| Fusion Device | Intervertebral Body | ||||
| Fusion Device | Equivalent | ||||
| Product Code | OVE | OVE | ODP | OVE | Equivalent |
| Indications for | |||||
| Use | The TiBrid™-SC | ||||
| standalone | |||||
| cervical | |||||
| intervertebral | |||||
| fusion device is | |||||
| indicated for use | |||||
| in anterior | |||||
| cervical interbody | |||||
| procedures in | |||||
| skeletally mature | |||||
| patients with | |||||
| cervical disc | |||||
| disease at one | |||||
| level from the C2- | |||||
| C3 disc to the C7- | |||||
| T1 disc. The | |||||
| implants are to be | |||||
| used with | |||||
| autogenous bone | The SeaSpine | ||||
| Shoreline™ ACS is | |||||
| a standalone device | |||||
| indicated for | |||||
| anterior cervical | |||||
| interbody fusion | |||||
| procedures in | |||||
| skeletally mature | |||||
| patients with | |||||
| degenerative disc | |||||
| disease of the | |||||
| cervical spine at a | |||||
| single level (C2- | |||||
| T1). The | |||||
| Shoreline™ ACS | |||||
| implants are to be | |||||
| used with autograft | |||||
| bone graft and/or | |||||
| allogenic bone graft | The TiBrid™ | ||||
| Cervical Cage is | |||||
| indicated for | |||||
| intervertebral body | |||||
| fusion procedures in | |||||
| skeletally mature | |||||
| patients with | |||||
| degenerative disc | |||||
| disease (DDD) at one | |||||
| or two contiguous | |||||
| levels within the | |||||
| cervical spine at disc | |||||
| levels from C2 to T1. | |||||
| DDD is defined as | |||||
| neck pain of | |||||
| discogenic origin | |||||
| with degeneration of | |||||
| the disc confirmed | |||||
| by patient history | The CoRoent Small | ||||
| Interlock System is a | |||||
| standalone anterior | |||||
| cervical interbody | |||||
| fusion | |||||
| system indicated for | |||||
| use in skeletally | |||||
| mature patients with | |||||
| cervical disc | |||||
| degeneration and/or | |||||
| cervical spinal | |||||
| instability, as | |||||
| confirmed by imaging | |||||
| studies (radiographs, | |||||
| CT, MRI), that | |||||
| results in | |||||
| radiculopathy, | |||||
| myelopathy, and/or | |||||
| pain at multiple | Equivalent | ||||
| Table 8.1: Dimensions and Technological Characteristics Comparison Cervical Plate Systems | |||||
| Item | Omnia Medical | ||||
| TiBrid™-SC | SeaSpine | ||||
| Shoreline™ ACS - | |||||
| Anterior Cervical | |||||
| Standalone System | |||||
| (K170569) | Omnia Medical | ||||
| TiBrid™-C | |||||
| (K190363) | NuVasive CoRoent | ||||
| Small Interlock | |||||
| System (K192582) | Comparison | ||||
| allograft | |||||
| comprised of | |||||
| cancellous and/or | |||||
| corticocancellous | |||||
| bone graft and | |||||
| implanted via an | |||||
| anterior approach. | |||||
| The device is to | |||||
| be used is patients | |||||
| who have had six | |||||
| weeks of non- | |||||
| operative | |||||
| treatment. The | |||||
| cervical | |||||
| standalone | |||||
| intervertebral | |||||
| body fusion | |||||
| device is to be | |||||
| used with either a | |||||
| minimum of two | |||||
| bone screws and a | |||||
| screw locking | |||||
| cover or a | |||||
| connecting plate. | cancellous and/or | ||||
| corticocancellous | |||||
| bone and implanted | |||||
| via an anterior | |||||
| approach. The | |||||
| cervical device is to | |||||
| be used in patients | |||||
| who have had at | |||||
| least six (6) weeks | |||||
| of non-operative | |||||
| treatment. The | |||||
| cervical device is to | |||||
| be used with | |||||
| Shoreline bone | |||||
| screw fixation and | |||||
| the Shoreline | |||||
| locking cover. | studies. Patients | ||||
| should have had at | |||||
| least six weeks of | |||||
| non-operative | |||||
| treatment prior to | |||||
| treatment with | |||||
| intervertebral cages. | |||||
| This device is | |||||
| intended for use with | |||||
| autogenous bone | |||||
| graft and/or allograft | |||||
| comprised of | |||||
| cancellous and/or | |||||
| corticocancellous | |||||
| bone graft and | |||||
| supplemental | |||||
| fixation. | contiguous levels | ||||
| from C2-T1. | |||||
| The System is | |||||
| intended to be used | |||||
| with autogenous | |||||
| and/or allogeneic bone | |||||
| graft comprised | |||||
| of cancellous, cortical, | |||||
| and/or | |||||
| corticocancellous | |||||
| bone graft to facilitate | |||||
| fusion. | |||||
| Description | The TiBrid™-SC | ||||
| system consists of | |||||
| a standalone | |||||
| hybrid PEEK | |||||
| OPTIMA™ HA | |||||
| Enhanced and | |||||
| titanium alloy | |||||
| cervical interbody | |||||
| device with 3 | |||||
| titanium plate | |||||
| options (two, | |||||
| three, and four | |||||
| screws) that can | |||||
| be connected to | |||||
| the standalone | |||||
| device. The | |||||
| standalone cages | |||||
| are available in | |||||
| multiple | |||||
| footprints and | The SeaSpine® | ||||
| Shoreline™ ACS - | |||||
| Anterior Cervical | |||||
| Standalone System | |||||
| consists of the | |||||
| implant assembly | |||||
| composed of a | |||||
| single use PEEK | |||||
| cervical spacer | |||||
| (ASTM F2026) and | |||||
| a titanium alloy | |||||
| (ASTM F136) plate | |||||
| with titanium alloy | |||||
| variable angle or | |||||
| fixed bone screws, | |||||
| and a titanium alloy | |||||
| locking cover. | |||||
| Shoreline™ ACS is | |||||
| offered in a variety | |||||
| of footprints and | The Omnia Medical | ||||
| TiBrid™ Systems | |||||
| are intervertebral | |||||
| body fusion systems | |||||
| used in the spine to | |||||
| replace a collapsed, | |||||
| damaged, or unstable | |||||
| disc. The implantable | |||||
| devices are | |||||
| manufactured from | |||||
| PEEK-OPTIMA™ | |||||
| HA Enhanced, | |||||
| titanium alloy, and | |||||
| tantalum for | |||||
| radiographic | |||||
| visualization. Each | |||||
| device is available in | |||||
| multiple footprints | |||||
| and heights. The | |||||
| implant features a | The NuVasive | ||||
| CoRoent Small | |||||
| Interlock System is a | |||||
| standalone anterior | |||||
| cervical interbody | |||||
| device consisting of a | |||||
| PEEK | |||||
| (polyetheretherketone) | |||||
| implant cage with | |||||
| titanium alloy and | |||||
| tantalum radiographic | |||||
| markers, titanium | |||||
| alloy washers, and | |||||
| three (3) titanium | |||||
| alloy bone fixation | |||||
| screws. The devices | |||||
| are manufactured | |||||
| from PEEK-Optima® | |||||
| LT1 conforming to | |||||
| ASTM F2026, | Equivalent | ||||
| Item | Omnia Medical | ||||
| TiBridTM-SC | SeaSpine | ||||
| ShorelineTM ACS - | |||||
| Anterior Cervical | |||||
| Standalone System | |||||
| (K170569) | Omnia Medical | ||||
| TiBridTM-C | |||||
| (K190363) | NuVasive CoRoent | ||||
| Small Interlock | |||||
| System (K192582) | Comparison | ||||
| heights, and have | |||||
| a lordotic angle of | |||||
| 6°. The plates are | |||||
| available in | |||||
| multiple heights. | |||||
| The cages feature | |||||
| a hollow center to | |||||
| accommodate | |||||
| autograft or | |||||
| allograft and | |||||
| include anti- | |||||
| migration | |||||
| features. All | |||||
| devices are to be | |||||
| used with | |||||
| autogenous bone | |||||
| graft and/or | |||||
| allograft | |||||
| comprised of | |||||
| cancellous and/or | |||||
| corticocancellous | |||||
| bone graft. | heights to | ||||
| accommodate | |||||
| variations in patient | |||||
| anatomy and is | |||||
| generally box- | |||||
| shaped with surface | |||||
| teeth and a central | |||||
| canal for receiving | |||||
| autograft bone graft | |||||
| material and/or | |||||
| allogeneic bone | |||||
| graft composed of | |||||
| cancellous and/or | |||||
| corticocancellous | |||||
| bone. The system is | |||||
| implanted via an | |||||
| anterior approach. | hollow center to | ||||
| accommodate | |||||
| autograft or allograft | |||||
| and includes anti- | |||||
| migration features. | |||||
| All devices are to be | |||||
| used with | |||||
| autogenous bone | |||||
| graft and/or allograft | |||||
| comprised of | |||||
| cancellous and/or | |||||
| corticocancellous | |||||
| bone graft and | |||||
| supplemental | |||||
| fixation. | titanium alloy | ||||
| conforming to ASTM | |||||
| F136, and tantalum | |||||
| conforming to ASTM | |||||
| F560. The implants | |||||
| are available in a | |||||
| variety of sizes to | |||||
| accommodate | |||||
| anatomical conditions. | |||||
| The CoRoent Small | |||||
| Interlock System is a | |||||
| standalone system | |||||
| intended to be used | |||||
| with the bone screws | |||||
| provided, and when | |||||
| used as such requires | |||||
| no additional | |||||
| supplemental fixation. | |||||
| Interbody | |||||
| Footprints | 16.5 x 14.5mm | ||||
| 18 x 15mm | 16 x 14mm | ||||
| 18 x 15mm | |||||
| 20 x 15mm | 14mm x 12mm | ||||
| 16mm x 13.5mm | |||||
| 18mm x 15mm | 17mm x 14mm | Equivalent | |||
| Interbody | |||||
| Heights | 6 - 12 mm, 1 mm | ||||
| increments | 5 - 12 mm, 1 mm | ||||
| increments | 5 - 12 mm, 1 mm | ||||
| increments | 5 - 12 mm, 1 mm | ||||
| increments | Equivalent | ||||
| Interbody | |||||
| Lordosis | 6° | 7°, 10°, 15° | 6° | 6° | Equivalent |
| Plate | |||||
| Configurations | 2,3 and 4 screw | 2,3, and 4 screw | N/A | N/A | Equivalent |
| Screw | |||||
| Diameters | Ø4.0 or 4.5 mm | Ø3.5 or 4.0 mm | N/A | Ø4.0 or 4.5 mm | Equivalent |
| Screw Lengths | 10 – 18 mm | 10 - 18mm | N/A | 12 – 16 mm | Equivalent |
| Screw Styles | Self-Drilling & | ||||
| Self-Tapping, | |||||
| Fixed & Variable | Self-Drilling & | ||||
| Self-Tapping, Fixed | |||||
| & Variable | N/A | Self-Drilling & Self- | |||
| Tapping, Fixed & | |||||
| Variable | Equivalent | ||||
| Graft | |||||
| Windows | Yes | Yes | Yes | Yes | Equivalent |
| Bone Graft | |||||
| Contact Area | 73 mm² | 65 mm² | 63 mm² | Unknown | Equivalent |
| Insertion | |||||
| Features | Threaded hole | Threaded hole | Threaded hole | Unknown | Equivalent |
| Table 8.1: Dimensions and Technological Characteristics Comparison Cervical Plate Systems | |||||
| Item | Omnia Medical | ||||
| TiBrid™-SC | SeaSpine | ||||
| Shoreline™ ACS - | |||||
| Anterior Cervical | |||||
| Standalone System | |||||
| (K170569) | Omnia Medical | ||||
| TiBrid™-C | |||||
| (K190363) | NuVasive CoRoent | ||||
| Small Interlock | |||||
| System (K192582) | Comparison | ||||
| Anti-Migration | |||||
| Features | Yes | Yes | Yes | Yes | Equivalent |
| Interbody | |||||
| Materials | PEEK- | ||||
| OPTIMA™ HA | |||||
| Enhanced per | |||||
| ASTM F2026, | |||||
| Titanium Alloy | |||||
| per ASTM F3001, | |||||
| Titanium Alloy | |||||
| per ASTM F136 | PEEK-OPTIMA™ | ||||
| per (ASTM 2026), | |||||
| titanium alloy | |||||
| (ASTM F136), | |||||
| Tantalum (ASTM | |||||
| f560), CP Titanium | |||||
| Surface (ASTMf67) | PEEK-OPTIMA™ | ||||
| HA Enhanced (per | |||||
| ASTM F2026) and | |||||
| Ti-6Al-4V ELI (per | |||||
| ASTM F3001), | |||||
| Titanium Alloy per | |||||
| ASTM F136 | PEEK-OPTIMA™ | ||||
| per (ASTM 2026), | |||||
| titanium alloy (ASTM | |||||
| F136) | Equivalent | ||||
| Plate Materials | Titanium Alloy | ||||
| per ASTM F136 | Titanium Alloy per | ||||
| ASTM F136 | N/A | N/A | Equivalent | ||
| Screw | |||||
| Materials | Titanium Alloy | ||||
| per ASTM F136 | Titanium Alloy per | ||||
| ASTM F136 | N/A | Titanium Alloy per | |||
| ASTM F136 | Equivalent |
5
Image /page/5/Picture/0 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray wave-like graphic on the left, followed by the words "Omnia" and "Medical" stacked on top of each other on the right. The word "Omnia" is in a bold, dark blue font, while the word "Medical" is in a lighter gray font.
6
Image /page/6/Picture/0 description: The image shows the logo for Omnia Medical. The logo consists of a stylized wave-like graphic in blue and gray on the left, followed by the words "Omnia" in a bold, dark blue font and "Medical" in a smaller, gray font below it. The overall design is clean and professional, suggesting a company in the healthcare or medical field.
7
Image /page/7/Picture/0 description: The image shows the logo for Omnia Medical. The logo consists of a stylized wave-like graphic in navy blue and gray on the left, followed by the words "Omnia" in a larger, bold, navy blue font and "Medical" in a smaller, gray font below it. The overall design is clean and professional.
Mechanical Testing:
Substantial equivalence is supported by the results of mechanical testing including static and dynamic compression per ASTM F2077, static and dynamic torsion per ASTM F2077, static and dynamic compression shear per ASTM F2077, subsidence per ASTM F2267, and expulsion testing.
Conclusion:
Based on the indications for use, technological characteristics (i.e. design, material, and chemical composition), and comparison with the predicate device, the subject device has demonstrated substantial equivalence.