Omnia Medical VBR

K172323 · Omnia Medical, LLC · MQP · Oct 26, 2017 · Orthopedic

Device Facts

• Record ID: K172323
• Device Name: Omnia Medical VBR
• Applicant: Omnia Medical, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Oct 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omnia Medical VBR is a vertebral body replacement system indicated for use to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.

Device Story

Vertebral body replacement system; replaces collapsed/unstable vertebral bodies in thoracolumbar spine (T1-L5). Implant features hollow center/through holes for bone graft (autograft/allograft) to promote fusion. Requires supplemental fixation. Surgeon-implanted in clinical setting. Provides structural support to spine; facilitates bone growth; restores spinal stability. Benefits patient by replacing damaged vertebrae and stabilizing spine.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F2077 (static/dynamic compression and torsion) and ASTM F2267 (subsidence), plus expulsion testing.

Technological Characteristics

Constructed from PEEK-OPTIMA™ HA Enhanced (ASTM F2026) and tantalum markers (ASTM F560). Modular design with spacers and endplates for height/lordosis adjustment. Hollow geometry for bone graft. Standalone implant requiring supplemental fixation.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracolumbar spine (T1-L5) due to collapsed, damaged, or unstable vertebral bodies caused by tumor or trauma (fracture). Must be used with supplemental fixation and autograft/allograft.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Vu Mesh VBR (K070381)

Reference Devices

• Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device (K142026)
• Talos®-C (HA) Cervical Intervertebral Body Fusion Devices (K142345)

Submission Summary (Full Text)

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Omnia Medical, LLC % Kevin Majka Quality System/Regulatory Engineer JALEX Medical 30311 Clemens Road Suite 5D Westlake, Ohio 44145

October 26, 2017

Re: K172323

Trade/Device Name: Omnia Medical VBR Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: MQP Dated: July 28, 2017 Received: August 1, 2017

Dear Mr. Majka:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K172323

Device Name Omnia Medical VBR

Indications for Use (Describe)

The Omnia Medical VBR is a vertebral body replacement system indicated for use to replace a collapsed, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Omnia Medical. The logo consists of the letters "OM" in a blue square on the left, followed by the words "OMNIA MEDICAL" in blue, sans-serif font. The letters "OM" are stylized, with the "O" overlapping the "M".

# 510(k) Summary

| Submitted By: | Omnia Medical, LLC<br>1000 Hampton Center Suite G<br>Morgantown, WV 26505 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | 07/28/2017 |
| Contact Person: | Kevin Majka, Quality System/Regulatory Engineer |
| Contact Telephone: | [phone] |
| Contact Fax: | [phone] |
| Device Trade Name: | Omnia Medical VBR |
| Device Classification Name: | Spinal intervertebral body fixation orthosis (21 CFR 888.3060) |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | MQP |
| Primary Predicate Device: | Vu Mesh VBR (K070381)<br>The predicate device has never been subject to a recall. |
| Reference Devices: | Arena-C® HA PEEK Cervical Intervertebral Body Fusion Device<br>(K142026)<br>Talos®-C (HA) Cervical Intervertebral Body Fusion Devices (K142345) |

#### Device Description:

The Omnia Medical VBR is manufactured from PEEK-OPTIMA™ HA Enhanced conforming to ASTM F2026 and tantalum markers conforming to ASTM F560. This implant is available in two footprint sizes and offers spacers and endplates which allow for fine adjustments of the height and lordosis to accommodate various patient anatomy. The device features a hollow center and through holes for use with autograft or allograft to encourage formation of new bone. The device is intended to be used with supplemental fixation.

#### Indications for Use:

The Omnia Medical VBR is a vertebral body replacement system indicated for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5). The device is intended for use with supplemental fixation cleared for use in the thoracolumbar spine and is to be used with autograft and/or allograft.

#### Summary of Technological Characteristics:

The Omnia Medical VBR and the predicate have the same intended use and fundamental scientific technology. Both devices compare similarly in:

- Design features
- Intended use
- Materials
- Dimensions
- Function

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Image /page/4/Picture/0 description: The image is a logo for Omnia Medical. The logo features the letters "OM" in a blue square on the left side of the image. To the right of the square, the word "OMNIA" is written in large, blue letters, with the word "MEDICAL" written in smaller, blue letters below it.

## 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, subsidence per ASTM F2267, and expulsion testing.

### Conclusion:

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