# K222806: Kodiak C Spinal Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Met One Technologies, LLC
- Decided: Dec 22, 2022 after 97 days
- Product code: ODP (Intervertebral Fusion Device With Bone Graft, Cervical)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K841189 (1984). 329 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 331 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161649: Virtu C Spinal Implant System, Met 1 Technologies, LLC (2016) Summary page 5.
- K170297: Tranquil Interbody System, Nexus Spine, LLC (2017) Summary page 5.
- K172446: SPIRA-C Open Matrix Cervical Interbody, Camber Spine Technologies (2017) Summary page 5.
- K172941: CASCADIA Interbody System, K2m (2018) Summary page 5.
- K172009: Cascadia Interbody System, K2m, Inc. (2017) Summary page 5.
- K162264: Cascadia Interbody System, K2m, Inc. (2016) Summary page 5.

## Most influential descendants
- K230851: Kodiak Lumbar Spacer System (2023), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K222806
Methodology: https://510kreport.com/methodology