# K230851: Kodiak Lumbar Spacer System

- Pathway: 510(k) (Traditional)
- Applicant: Met One Technologies, LLC
- Decided: May 26, 2023 after 59 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- 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: 23 generations back to K841189 (1984). 422 ancestors in all.
No later device cites it as a predicate yet.
1 of 423 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160699: VIRTU Lumbar Spacer System, Met 1 Technologies, LLC (2016) Summary page 5.
- K193457: AUDERE Lumbar Spacer System, Met One Technologies (2020) Summary page 5.
- K162496: Foundation 3D Interbody, Corelink, LLC (2017) Summary page 5.
- K221936: Standalone ALIF Interbody Fusion System, Eminent Spine (2022) Summary page 5.
- K222806: Kodiak C Spinal Implant System, Met One Technologies, LLC (2022) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K230851
Methodology: https://510kreport.com/methodology