# K192629: Spinalytics

- Pathway: 510(k) (Traditional)
- Applicant: Optima Health Solutions International Corp.
- Decided: Dec 21, 2019 after 89 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 KKT 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 quantifies the misalignment of vertebrae. The treatment is then administered using the KKT device to deliver impulses at a precise vector. Spinalytics is a software application which facilitates treatment using the KKT device. Spinalytics provides an interface to manage the patient information stored in a central database. Spinalytics facilitates measuring angles and distances of relevant skeletal structures in a patient, by providing the practitioner with an interface to mark the position of these structures directly on digitized X-Rays. Spinalytics then calculates standard treatment protocol parameters which can be sent directly to the KKT device. Spinalytics is an optional accessory to the KKT device and does not change the intended use of the device.

Source page: https://510kreport.com/device/K192629
Methodology: https://510kreport.com/methodology