# K160278: VSTAAR AdjusteR

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Acoustics, LLC
- Decided: Nov 4, 2016 after 276 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: 4 generations back to K930431 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962239: Smart Adjuster (SA201), Sigma (1997) Summary page 4.
- K973914: Sense Technology Inc. Fras, Sense Technology Inc. Pulstar, Sense Technology, Inc. (1998) Summary page 4.
- K080261: Impulse IQ Adjusting Instrument, Neuromechanical Innovations, LLC (2008) Summary page 4.

## Indications for use
The VSTAAR is a mechanical device intended to be used by chiropractors, medical doctors and other licensed health care professions for the external analysis and adjustment of the human spinal column, and for soft tissue musculoskeletal mobilization.

Source page: https://510kreport.com/device/K160278
Methodology: https://510kreport.com/methodology