← Product Code [ODP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/ODP) · K222806

# Kodiak C Spinal Implant System (K222806)

_Met One Technologies, LLC · ODP · Dec 22, 2022 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/ODP/K222806

## Device Facts

- **Applicant:** Met One Technologies, LLC
- **Product Code:** [ODP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/ODP.md)
- **Decision Date:** Dec 22, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3080
- **Device Class:** Class 2
- **Review Panel:** Orthopedic
- **Attributes:** Therapeutic

## Intended Use

The Kodiak C Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Kodiak C Cervical Cages are intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Kodiak C Cervical Cages are intended to be used with an FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of nonoperative treatment prior to treatment. The Kodiak C Corpectomy Cages are indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed, or unstable vertebral body due to trauma/fracture or tumor, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Kodiak C Corpectomy Cages are intended to be used with autograft and/or allograft bone. The Kodiak C Corpectomy Cages are intended to be used with an FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

## Device Story

Kodiak C Spinal Implant System consists of cervical intervertebral body fusion cages and thoracolumbar corpectomy cages; implanted into vertebral space to provide stability, support fusion, or replace damaged/collapsed vertebral bodies. Features central cavity for bone graft packing, teeth on superior/inferior surfaces to prevent expulsion, and lattice windows for radiographic visualization. Used by surgeons in clinical settings; requires supplemental fixation (e.g., pedicle screws). Benefits include spinal decompression, height restoration, and stabilization. Provided non-sterile; requires sterilization by user.

## Clinical Evidence

Bench testing only. Performance evaluated via static/dynamic compression (ASTM F2077), static/dynamic torsion (ASTM F2077), subsidence (ASTM F2267), and expulsion testing. No clinical data provided.

## Technological Characteristics

Additively manufactured Ti-6Al-4V ELI (ASTM F3001). Features central graft cavity, surface teeth, and lattice windows. Provided non-sterile. Mechanical performance validated per ASTM F2077 and F2267.

## Regulatory 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

- VIRTU C Spinal Implant System ([K161649](/device/K161649.md))
- Tranquil Interbody System ([K170297](/device/K170297.md))
- SPIRA-C Open Matrix Cervical Interbody ([K172446](/device/K172446.md))
- CASCADIA Interbody System ([K172941](/device/K172941.md), [K172009](/device/K172009.md), [K162264](/device/K162264.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}------------------------------------------------

Image /page/0/Picture/0 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.

December 22, 2022

Met One Technologies, LLC Adrian Carbonell Chief Operating Officer 513 W. San Antonio Ave, Suite C El Paso, Texas 79901

Re: K222806

Trade/Device Name: Kodiak C Spinal Implant System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, MOP Dated: November 30, 2022 Received: December 2, 2022

Dear Adrian Carbonell:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

{1}------------------------------------------------

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 medical devices and radiation-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

510(k) Number (if known) K222806

Device Name Kodiak C Spinal Implant System

#### Indications for Use (Describe)

The Kodiak C Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Kodiak C Cervical Cages are intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Kodiak C Cervical Cages are intended to be used with an FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of nonoperative treatment prior to treatment.

The Kodiak C Corpectomy Cages are indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed, or unstable vertebral body due to trauma/fracture or tumor, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Kodiak C Corpectomy Cages are intended to be used with autograft and/or allograft bone. The Kodiak C Corpectomy Cages are intended to be used with an FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

| Type of Use (Select one or both, as applicable)                                                        |                                                                                                |
|--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b>X</b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: underline;"> </span> Over-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."

{3}------------------------------------------------

## 5. 510(K) SUMMARY

| Date:                   | September 7, 2022                                                                                 |
|-------------------------|---------------------------------------------------------------------------------------------------|
| Sponsor:                | Met One Technologies, LLC                                                                         |
|                         | 513 W. San Antonio Ave Ste. C                                                                     |
|                         | El Paso, TX 79901                                                                                 |
|                         | (915)373-3855                                                                                     |
| Sponsor Contact:        | Adrian Carbonell, Chief Operating Officer                                                         |
| Proposed Trade<br>Name: | Kodiak C Spinal Implant System                                                                    |
| Common Name:            | Intervertebral Fusion Device with Bone Graft, Cervica<br>Spinal Vertebral Body Replacement Device |
| Classification:         | Class II per 21 CFR 888.3080<br>Class II per 21 CFR 888.3060                                      |
| Product Code:           | ODP, MOP                                                                                          |

Classification Panel: Division of Orthopedic Devices

- Device Description: The Met One Technologies Kodiak C Cervical Cage is a cervical intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The cervical cages have a central cavity to permit the packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces to resist expulsion, and lattice windows for radiographic visualization. The implants are additively manufactured from Ti-6A1-4V ELI and are available in a variety of height, footprints, and lordotic configurations to suit individual patient anatomy.
The Met One Technologies Kodiak C Corpectomy Cage is a thoracolumbar vertebral body replacement device (VBR) that is implanted to achieve anterior decompression of the spinal cord and neural tissues and to restore the height of a collapsed vertebral body. The corpectomy cages have a central cavity to permit the packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces to resist expulsion, and lattice windows for radiographic visualization. The implants are available

{4}------------------------------------------------

in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.

Indications for Use: The Kodiak C Cervical Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine (C2-T1). The Kodiak C Cervical Cages are intended to be used with autograft and/or allograft bone (allogenic bone graft comprised of cancellous and/or corticocancellous bone graft). The Kodiak C Cervical Cages are intended to be used with an FDA cleared cervical supplemental fixation system. Patients should receive 6 weeks of non-operative treatment prior to treatment.

> The Kodiak C Corpectomy Cages are indicated for use in the thoracolumbar spine (T1-L5) for partial or total replacement of a damaged, collapsed, or unstable vertebral body due to trauma/fracture or tumor, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Kodiak C Corpectomy Cages are intended to be used with autograft and/or allograft bone. The Kodiak C Corpectomy Cages are intended to be used with an FDA cleared supplemental fixation device such as a lumbar pedicle screw system.

| Materials: | The Kodiak C Spinal Implant System is comprised of a family of implants<br>that has bodies additively manufactured from Ti-6Al-4V Eli, in<br>compliance with ASTM F3001. |
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Primary Predicate: VIRTU C Spinal Implant System (Met One Technologies, LLC -K161649)

Additional

- Tranquil Interbody System (Nexxus Spine, LLC K170297) Predicates: SPIRA-C Open Matrix Cervical Interbody (Camber Spine Technologies -K172446) CASCADIA Interbody System (K2M, Inc. - K172941, K172009, K162264)

{5}------------------------------------------------

# K222806
Page 3 of 3

| Performance Data:                 | The Kodiak C Spinal Implant System has been tested in accordance with<br>the following test modes and demonstrated substantial equivalence:<br>Static Compression per ASTM F2077 Dynamic compression per ASTM F2077 Static Torsion per ASTM F2077 Dynamic Torsion per ASTM F2077 Subsidence per ASTM F2267 Expulsion                                                                                                                                                                                                                             |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics: | The Kodiak C Spinal Implant System possesses the same technological<br>characteristics as one or more of the predicate devices. These include:<br>Indications for use Operating principle Materials of manufacture (Ti-6Al-4V Eli) Sterilization (provided nonsterile with instruction for sterilization) Basic design (similar height, width, depth, and lordosis) Graft containment area              Therefore, the fundamental scientific technology of the Kodiak C Spinal<br>Implant System is the same as the previously cleared devices. |
| Conclusion:                       | The Kodiak C Spinal Implant System possesses the same intended use and<br>technological characteristics as the predicate devices. Therefore, the<br>Kodiak C Spinal Implant System is substantially equivalent for its<br>intended use.                                                                                                                                                                                                                                                                                                          |

---

**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/ODP/K222806](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/ODP/K222806)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com