# K230424: Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ Lateral Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Omnia Medical, LLC
- Decided: Apr 12, 2023 after 54 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: 10 generations back to K990745 (1999). 160 ancestors in all.
No later device cites it as a predicate yet.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221728: Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate, Stryker Corporation (2022) Summary page 4.

## Indications for use
The Coupler-A™ and Coupler-L™ Lumbar Plate Systems are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the vessels 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/K230424
Methodology: https://510kreport.com/methodology