Who is the manufacturer of Omnia Medical TiBrid-SA System?

Omnia Medical, LLC filed the 510(k) submission for Omnia Medical TiBrid-SA System (K240623).

What is the FDA product code for Omnia Medical TiBrid-SA System?

OVD. It is classified under 21 CFR 888.3080 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Omnia Medical TiBrid-SA System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Omnia Medical TiBrid-SA System?

Omnia TiBrid™-SA Intervertebral Fusion Device (K203207); SeaSpine Zuma™ System (K082926).

Who can help prepare an FDA 510(k) submission like Omnia Medical TiBrid-SA System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Omnia Medical TiBrid-SA System

K240623 · Omnia Medical, LLC · OVD · Apr 24, 2024 · Orthopedic

Device Facts

Record ID	K240623
Device Name	Omnia Medical TiBrid-SA System
Applicant	Omnia Medical, LLC
Product Code	OVD · Orthopedic
Decision Date	Apr 24, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3080
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The TiBrid™ SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device is intended for use with autogenous bone graft and/or allograft compromised of cancellous and/or corticocancellous bone graft and integrated fixation. The TiBrid™ -SA is a standalone device and must be used with the internal bone screws or TiBrid™. SA plate and bone screws provided.

Device Story

Standalone intervertebral body fusion system; replaces collapsed, damaged, or unstable discs in lumbar spine (L2-S1). Implant features hollow center for autograft/allograft bone graft; includes anti-migration features. Manufactured from PEEK-OPTIMA HA Enhanced, titanium alloy, and tantalum markers. Available in multiple footprints, heights, and angles. Used by surgeons in clinical settings to restore disc height and facilitate spinal fusion. Integrated fixation via internal bone screws or plate-and-screw system. Provides mechanical stability to spinal column; benefits patient by promoting fusion and alleviating discogenic back pain.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including static and dynamic compression shear testing per ASTM F2077.

Technological Characteristics

Materials: PEEK-OPTIMA HA Enhanced (ASTM F2026), Ti-6Al-4V ELI (ASTM F3001), Tantalum (ASTM F560). Fixation: Integrated bone screws/plate. Sensing: Tantalum markers for radiographic visualization. Form factor: Hollow interbody cage with anti-migration features. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade 1 spondylolisthesis, who have failed six months of nonoperative therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Omnia TiBrid™-SA Intervertebral Fusion Device (K203207)
SeaSpine Zuma™ System (K082926)

Related Devices

K202380 — Born PT-LIF Cage HA · Spineworxx AG · Feb 19, 2021
K200552 — EVOS Lumbar Interbody System · Cutting Edge Spine, LLC · Apr 2, 2020
K203207 — Omnia Medical TiBrid-SA · Omnia Medical, LLC · Dec 23, 2020
K181386 — NuVasive Brigade Lateral System · Nu Vasive, Incorporated · Aug 24, 2018
K160051 — NuVasive® Interfixated Interbody System · Nu Vasive, Incorporated · Apr 20, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ April 24, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Omnia Medical, LLC % Jennifer Palinchik President JALEX Medical, LLC 27865 Clemens Rd., Suite 3 Westlake, Ohio 44145 Re: K240623 Trade/Device Name: Omnia Medical TiBrid™-SA System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: March 20, 2024 Received: March 20, 2024 #### 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, # Katherine D. Kavlock -S for 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 Submission Number (if known) K240623 Device Name Omnia Medical TiBrid TM -SA System Indications for Use (Describe) The TiBrid™ SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device is intended for use with autogenous bone graft and/or allograft compromised of cancellous and/or corticocancellous bone graft and integrated fixation. The TiBrid™ -SA is a standalone device and must be used with the internal bone screws or TiBrid™. SA plate and bone screws provided. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) ver-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. {3}------------------------------------------------ Image /page/3/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 words "Omnia Medical" in blue and gray on the right. The word "Omnia" is in 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: | 04/15/2024 | | Contact Person: | Jennifer Palinchik, President, JALEX Medical | | Contact Telephone: | (440) 935-3282 | | Contact Fax: | (440) 933-7839 | | Device Trade Name: | Omnia Medical TiBrid™-SA | | Common Name: | Intervertebral Body Fusion Device | | Device Classification Name: | Intervertebral Body Fusion Device with Integrated Fixation, Lumbar | | Device Classification: | Class II | | Reviewing Panel: | Orthopedic | | Product Code: | OVD | | Primary Predicate Device: | Omnia TiBrid™-SA Intervertebral Fusion Device (K203207) | | Additional Predicate: | SeaSpine Zuma™ System (K082926) | #### Device Description: The Omnia Medical TiBrid™-SA System is a standalone intervertebral body fusion system 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, heights, and angles. The implants 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 and integrated fixation. #### Indications for Use: The TiBrid™-SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device is intended for use with autogenous bone graft and/or allograft compromised of cancellous and/or corticocancellous bone graft and integrated fixation. The TiBrid™-SA is a standalone device and must be used with the internal bone screws or TiBrid™-SA plate and bone screws provided. #### Summary of Technological Characteristics: The Omnia Medical TiBrid™-SA System and the predicate devices have the same intended use and fundamental scientific technology. All devices compare similarly in: - Design features ● {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray wave-like design on the left, with the words "Omnia Medical" in blue and gray on the right. The word "Omnia" is in blue, and the word "Medical" is in gray. - Intended use . - Materials ● - Dimensions ● - Function ● | Item | Subject Device: Omnia Medical TiBrid™-SA | Omnia Medical TiBrid™-SA (K203207) | Zuma™ System, SeaSpine Inc. (K082926) | Comparison | |----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Comparison component to subject device | N/A | Interbody, screws, screw covers | Interbody, screws, and plate combination | N/A | | Device Classification Name | Intervertebral Fusion Device with Integrated Fixation, Lumbar | Intervertebral Fusion Device with Integrated Fixation, Lumbar | Intervertebral Fusion Device with Integrated Fixation, Lumbar | Equivalent | | Regulation | 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 | Equivalent | | Product Code | OVD | OVD | OVD | Equivalent | | Indications for Use | The TiBrid™-SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device | The TiBrid™-SA system is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). Patients should have six months of nonoperative therapy. This device | When used as an intervertebral body fusion device, the Zuma-L System is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous | Equivalent | {5}------------------------------------------------ Image /page/5/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 word "Omnia" in blue and the word "Medical" in gray on the right. The graphic appears to be a stylized representation of a wave or a mountain range. | may be packed with | may be packed with | non-fusion spinal | |------------------------------------|------------------------------------|---------------------------------------------| | autogenous bone graft material. | autogenous bone graft material. | surgery at the | | | | involved spinal | | The TiBridTM-SA is | The TiBridTM-SA is | level(s). These | | a standalone device | a standalone device | patients should have | | and must be used | and must be used | had six months of | | with the internal | with the internal | non-operative | | bone screws or | bone screws | treatment. The | | TiBridTM-SA plate | provided. | device is intended to | | and bone screws | | be used with | | provided. | | autograft. Zuma-L is | | | | a stand-alone system | | | | intended to be used | | | | with the bone screws | | | | provided and | | | | requires no | | | | additional | | | | supplementary | | | | fixation systems. | | | | | | | | When used as a | | | | Vertebral Body | | | | Replacement | | | | Device, the Zuma-L | | | | System is intended | | | | for use in the | | | | thoracolumbar spine | | | | (T1 to L5) to replace | | | | a collapsed, | | | | diseased, damaged | | | | or unstable complete | | | | or partial vertebral | | | | body due to tumor or trauma/fracture, to | | | | achieve anterior | | | | decompression of the spinal cord and | | | | neural tissues, and to | | | | restore the height of | | | | a collapsed vertebral | | | | body. The Zuma-L | | | | System is designed | | | | to restore the | | | | biomechanical | | | | integrity of the | | | | anterior, middle, and | | | | posterior spinal | | | | column, even in the | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for Omnia Medical. The logo consists of a blue and gray circular design on the left, with the words "Omnia Medical" in blue and gray on the right. The word "Omnia" is in blue, and the word "Medical" is in gray. | | | | a prolonged period. Additionally, Zuma- L is intended for use with bone graft. | | |------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Description | The Omnia Medical TiBrid™-SA System is a standalone intervertebral body fusion system 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 implants 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 and integrated fixation. 32mm x 25mm | The Omnia Medical TiBrid™-SA System is a standalone intervertebral body fusion system 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 implants 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 and integrated fixation. 32mm x 25mm | Zuma is an implantable spinal device made from PEEK-OPTIMA® LT1 and titanium with tantalum markers for radiographic visualization. It is secured to vertebral bodies with titanium bone screws. The device has open central area for receiving bone graft material and is offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. | Equivalent | | Footprint Sizes (width x length) | 36mm x 27mm 40mm x 29mm | 36mm x 27mm 40mm x 29mm | 26mm x 24mm 32mm x 25mm 38mm x 26mm | Equivalent | | Interbody Heights | 10, 12, 14, 16, 18mm | 10, 12, 14, 16, 18mm | 10, 12, 14, 16, 18mm | Equivalent | | Interbody Angles | 8, 12, 16, 20° | 8, 12, 16, 20° | 8, 12° | Equivalent | | Graft Window | Yes | Yes | Yes | Equivalent | | Insertion Feature | Threaded hole | Threaded hole | Threaded hole | Equivalent | | Anti-Migration Features | Yes | Yes | Yes | Equivalent | | Use with supplemental fixation | No | No | Fusion device - no Body replacement - yes | Equivalent | | Interbody Material & Manufacturing | PEEK-OPTIMA™ HA Enhanced (per ASTM F2026), Ti- 6Al-4V ELI (per ASTM F3001), Tantalum (per ASTM F560). | PEEK-OPTIMA™ HA Enhanced (per ASTM F2026), Ti- 6Al-4V ELI (per ASTM F3001), Tantalum (per ASTM F560). | PEEK-OPTIMA® LT1, Titanium alloy, Tantalum marker | Equivalent | | Screw Diameters | 5.5mm, 6.0mm self tapping and self drilling | 5.5mm, 6.0mm self tapping and self drilling | 5.5mm, 6mm self- tapping | Equivalent | | Screw Lengths | 15 - 35mm (5mm increments) | 15 - 35mm (5mm increments) | 20, 25, 30, 35mm | Equivalent | | Screw Material | Medical grade Ti6Al4V ELI per ASTM F136 | Medical grade Ti6Al4V ELI per ASTM F136 | Medical grade Ti6Al4V ELI | Equivalent | | Plate Lengths | 30, 32, 34, 36, 38 mm | N/A | 43, 44, 45 mm | Equivalent | {7}------------------------------------------------ Image /page/7/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" and "Medical" are stacked on top of each other, with "Omnia" being in dark blue and "Medical" being in gray. #### Performance Data - Non-Clinical: Non-clinical tests were conducted to verify that the proposed device met all design specifications as Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with ASTM F2077 Standard Test Methods for Intervertebral Body Fusion Devices by performing static and dynamic compression shear testing. #### Performance Data - Clinical: Clinical Studies were not applicable to support a substantial equivalence determination for this device. The mechanical testing results, material, indications and intended uses, and device function are comparable to the predicate device. #### Conclusion: Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.