# K232154: MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: Sep 11, 2023 after 53 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 22 generations back to K841189 (1984). 367 ancestors in all.
No later device cites it as a predicate yet.
1 of 368 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172941: CASCADIA Interbody System, K2m (2018) Summary page 4.
- K191906: MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF, MiRus, LLC (2020) Summary page 4.

## Indications for use
The MiRus™ 3DR Lumbar Interbody Fusion System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral body fusion device. When used with or without the MiRus MoRe Lateral Lumbar Plating System, the system is indicated for use with supplemental fixation cleared by the FDA for use in the lumbar spine.

Source page: https://510kreport.com/device/K232154
Methodology: https://510kreport.com/methodology