(97 days)
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.
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 in a variety of heights, footprints, and lordotic configurations to suit individual patient anatomy.
This document is a 510(k) Summary for the Kodiak C Spinal Implant System, a medical device. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving performance against specific acceptance criteria in the context of AI/ML or diagnostic performance.
Therefore, the information requested regarding acceptance criteria, study details (sample size, data provenance, expert qualification, adjudication, MRMC, standalone performance, ground truth), training set sample size, and ground truth establishment cannot be fully provided from the given document. This document describes mechanical and material testing, not diagnostic or AI performance.
Here's an attempt to answer based on the provided text, highlighting what is present and what is missing:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests conducted, but it does not explicitly state quantitative acceptance criteria or reported numerical performance values for these tests. It only states that the device "demonstrated substantial equivalence" to predicate devices, implying that the results met relevant industry standards (e.g., ASTM standards) but without providing the actual data or specific thresholds.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Compliance with ASTM F2077 for Static Compression | Demonstrated substantial equivalence |
| Compliance with ASTM F2077 for Dynamic Compression | Demonstrated substantial equivalence |
| Compliance with ASTM F2077 for Static Torsion | Demonstrated substantial equivalence |
| Compliance with ASTM F2077 for Dynamic Torsion | Demonstrated substantial equivalence |
| Compliance with ASTM F2267 for Subsidence | Demonstrated substantial equivalence |
| Expulsion resistance | Demonstrated substantial equivalence |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not specified. The document refers to "the following test modes" and implies mechanical testing of devices, not clinical studies with patient data.
- Data provenance: Not applicable in the context of mechanical device testing. The tests are likely performed in a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a medical device approval involving mechanical properties and material composition, not diagnostic interpretation by experts. Ground truth in this context would refer to material specifications and engineering standards, not expert medical opinions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for subjective interpretations of data, not for objective mechanical test results.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This document does not mention any MRMC study or AI assistance. The device is a physical spinal implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This document does not pertain to an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this type of device (spinal implant) would be established by engineering specifications, material standards (e.g., ASTM F3001 for Ti-6Al-4V ELI), and biomechanical testing standards (e.g., ASTM F2077, ASTM F2267). The device's performance is compared against these known, objective standards to demonstrate substantial equivalence to legally marketed predicate devices.
8. The sample size for the training set
- Not applicable. This document does not describe an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This document does not describe an AI/ML device.
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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
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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
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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) | |
|---|---|
| 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: | 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 TradeName: | Kodiak C Spinal Implant System |
| Common Name: | Intervertebral Fusion Device with Bone Graft, CervicaSpinal Vertebral Body Replacement Device |
| Classification: | Class II per 21 CFR 888.3080Class 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
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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 implantsthat has bodies additively manufactured from Ti-6Al-4V Eli, incompliance 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)
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K222806
Page 3 of 3
| Performance Data: | The Kodiak C Spinal Implant System has been tested in accordance withthe following test modes and demonstrated substantial equivalence: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 |
|---|---|
| TechnologicalCharacteristics: | The Kodiak C Spinal Implant System possesses the same technologicalcharacteristics 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) Graft containment area Therefore, the fundamental scientific technology of the Kodiak C SpinalImplant System is the same as the previously cleared devices. |
| Conclusion: | The Kodiak C Spinal Implant System possesses the same intended use andtechnological characteristics as the predicate devices. Therefore, theKodiak C Spinal Implant System is substantially equivalent for itsintended use. |
§ 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.