# K234036: Sonik Monark 100

- Pathway: 510(k) (Traditional)
- Applicant: Neuro Spinal Innovation, Inc.
- Decided: Feb 15, 2024 after 56 days
- Product code: LXM (Manipulator, Plunger-Like Joint)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K951217 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130666: Khan Kinetic Treatment (KKT-M2), Optima Health Solutions International Corporation (2014) Summary page 5.

## Indications for use
The SONIK MONARK 100 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the device to deliver precise impulses at a required vector configuration.

Source page: https://510kreport.com/device/K234036
Methodology: https://510kreport.com/methodology