(50 days)
No
The document describes a physical implantable device and its intended use, materials, and performance testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device is indicated as an adjunct to fusion for treating degenerative disc disease, which involves alleviating pain and restoring stability, classifying it as a therapeutic device.
No
The device is an intervertebral body fusion system, which is a therapeutic device intended to replace a damaged disc, not diagnose a condition.
No
The device description explicitly states that the system includes implantable devices manufactured from PEEK-OPTIMA™ HA Enhanced, titanium alloy, and tantalum, which are hardware components.
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, tissue) to provide information about a person's health.
- Device Description: The TiBrid™ SA system is an implantable device designed to replace a damaged disc in the spine. It is surgically implanted into the body.
- Intended Use: The intended use is as an adjunct to fusion in patients with degenerative disc disease. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The description clearly indicates a surgically implanted device used for treatment, not a diagnostic test.
N/A
Intended Use / 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.
Product codes
OVD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
L2 to S1 (lumbar spine)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Omnia TiBrid™-SA Intervertebral Fusion Device (K203207), SeaSpine Zuma™ System (K082926)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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)
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)
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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 ●
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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 |
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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 |
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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 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 |
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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.