(59 days)
No
The document describes a physical implantable device for spinal fusion and does not mention any software, algorithms, or data processing capabilities that would suggest the use of AI or ML.
Yes
The device is a lumbar intervertebral body fusion device that is implanted to improve spinal stability and support fusion for conditions like degenerative disc disease, treating a medical condition.
No
This device is an implantable lumbar intervertebral body fusion device designed to provide stability and support fusion in spinal procedures, not to diagnose medical conditions.
No
The device description clearly states that the Kodiak Lumbar Spacer System is a physical implant made from Ti-6A1-4V ELI, designed to be surgically implanted into the vertebral body space. This is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The Kodiak Lumbar Spacer System is an implantable medical device designed to be surgically placed into the lumbar spine to aid in spinal fusion. It is a physical device that is part of a surgical procedure, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a surgical procedure for treating degenerative disc disease by promoting spinal fusion. This is a therapeutic intervention, not a diagnostic test.
The provided information describes a surgical implant, not a device used for testing biological samples.
N/A
Intended Use / Indications for Use
The Kodiak Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the Kodiak Lumbar Spacer System. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the Kodiak Lumbar Spacer System.
The Kodiak Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.
Product codes
MAX
Device Description
The Met One Technologies Kodiak Lumbar Spacer System is a lumbar intervertebral body fusion device that is implanted into the vertebral body space to improve stability of the spine while supporting fusion. The Kodiak Lumbar Spacer System may be implanted bilaterally using a posterior (PLIF) approach, or as a single device employing a transformational (TLIF) approach. The implants have a central endplate window to permit packing of autograft and/or allograft bone, teeth on the superior and inferior surfaces, and lateral windows for radiographic visualization. The implants are additively manufactured from Ti-6A1-4V ELI and are available in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar spine (L2-S1)
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)
The Kodiak Lumbar Spacer System has been evaluated in accordance with the following test modes and demonstrated substantial equivalence:
- Static Compression per ASTM F2077
- Dynamic Compression per ASTM F2077
- Static Compression-Shear per ASTM F2077
- Dynamic Compression-Shear per ASTM F2077
- Subsidence per ASTM F2267
- Expulsion
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AUDERE Lumbar Spacer System (Met One Technologies, LLC - K160699, K193457), Foundation 3D Interbody Lumbar Cage (CoreLink, LLC - K162496), Standalone ALIF Interbody Fusion Device (Eminent Spine, LLC - K221936), Kodiak C Spinal Implant System (Met One Technologies, LLC - K222806)
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
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May 26, 2023
Met One Technologies, LLC Adrian Carbonell Chief Operating Officer 513 W. San Antonio Ave, Suite C El Paso, Texas 79901
Re: K230851
Trade/Device Name: Kodiak Lumbar Spacer System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX Dated: March 22, 2023 Received: March 28, 2023
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 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K230851
Device Name Kodiak Lumbar Spacer System
Indications for Use (Describe)
The Kodiak Lumbar Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous non-fusion spinal surgery at the involved level may be treated with the Kodiak Lumbar Spacer System. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the Kodiak Lumbar Spacer System.
The Kodiak Lumbar Spacer System is designed for use with autogenous bone graft. The system is also intended to be used with supplemental fixation systems that are cleared by the FDA for use in the lumbar spine.
| 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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5. 510(K) SUMMARY
| Date: | March 22, 2023 |
|---|---|
| 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 Name: | Kodiak Lumbar Spacer System |
| Common Name: | Intervertebral Fusion Device with Bone Graft, Lumbar |
| Classification: | Class II per 21 CFR 888.3080 |
| Product Codes: | MAX |
| Classification Panel: | Division of Orthopedic Devices |
| Device Description: | The Met One Technologies Kodiak Lumbar Spacer System is a lumbar |
| intervertebral body fusion device that is implanted into the vertebral body | |
| space to improve stability of the spine while supporting fusion. The | |
| Kodiak Lumbar Spacer System may be implanted bilaterally using a | |
| posterior (PLIF) approach, or as a single device employing a | |
| transformational (TLIF) approach. The implants have a central endplate | |
| window to permit packing of autograft and/or allograft bone, teeth on the | |
| superior and inferior surfaces, and lateral windows for radiographic | |
| visualization. The implants are additively manufactured from Ti-6A1-4V | |
| ELI and are available in a variety of heights, footprints, and lordotic | |
| configurations to suit individual patient anatomy. | |
| Indications for Use: | The Kodiak Lumbar Spacer System is indicated for spinal fusion |
| procedures in skeletally mature patients with degenerative disc disease | |
| Lumbar Spacer System. Patients must have undergone a regimen of at | |
| least six (6) months of nonoperative treatment prior to being treated with | |
| the Kodiak Lumbar Spacer System. | |
| The Kodiak Lumbar Spacer System is designed for use with autogenous | |
| bone graft. The system is also intended to be used with supplemental | |
| fixation systems that are cleared by the FDA for use in the lumbar spine. | |
| Materials: | The Kodiak Lumbar Spacer System is comprised of a family of implants |
| that has bodies additively manufactured from Ti-6Al-4V Eli, in | |
| compliance with ASTM F3001. | |
| Primary Predicate: | AUDERE Lumbar Spacer System (Met One Technologies, LLC - |
| K160699, K193457) | |
| Additional | |
| Predicates: | Foundation 3D Interbody Lumbar Cage (CoreLink, LLC - K162496) |
| Standalone ALIF Interbody Fusion Device (Eminent Spine, LLC - | |
| K221936) | |
| Kodiak C Spinal Implant System (Met One Technologies, LLC - | |
| K222806) | |
| Performance Data: | The Kodiak Lumbar Spacer System has been evaluated in accordance with |
| the following test modes and demonstrated substantial equivalence: | |
| Static Compression per ASTM F2077 | |
| -- | |
| Dynamic Compression per ASTM F2077 | |
| -- | |
| Static Compression-Shear per ASTM F2077 | |
| -- | |
| Dynamic Compression-Shear per ASTM F2077 |
Subsidence per ASTM F2267
| Expulsion |
|---|
| Technological |
| Characteristics: |
| characteristics as one or more of the predicate devices. These include: |
| 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) |
|---|
fusion disc disease (DDD) at one or two contiguous levels in the lumbar spine (L2-S1) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients with previous nonfusion spinal surgery at the involved level may be treated with the Kodiak
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5
Graft containment area -
Therefore, the fundamental scientific technology of the Kodiak Lumbar Spacer System is the same as the previously cleared devices.
Conclusion: The Kodiak Lumbar Spacer System possesses the same intended use and technological characteristics as the predicate devices. Therefore, the Kodiak Lumbar Spacer System is substantially equivalent for its intended use.