# K241175: MiRus MoRe Lumbar Plating System

- Pathway: 510(k) (Traditional)
- Applicant: MiRus, LLC
- Decided: May 17, 2024 after 21 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K990745 (1999). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150449: LITe Plate System, Stryker Corp. (2015) Summary page 4.
- K220441: CYGNUS™ MoRe Anterior Cervical Plate System, MiRus, LLC (2022) Summary page 4.

## Indications for use
The MiRus MoRe Lumbar Plating System is indicated for use via lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: * Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); * Pseudoarthrosis; » Spondylolysis; » Spondylolisthesis; * Spinal stenosis; * Tumors; * Trauma (i.e. Fractures or Dislocation); * Deformities (i.e. Scoliosis, Kyphosis or Lordosis); * Failed Previous Fusion

Source page: https://510kreport.com/device/K241175
Methodology: https://510kreport.com/methodology