# K253523: Freedom DS™ Decompression System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Simplicity
- Decided: Apr 16, 2026 after 154 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K922881 (1992). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233800: Vertos mild Device Kit (MDK-0002), Vertos Medical, Inc. (2024) Summary page 5.

## Indications for use
The Freedom DS™ Decompression System is used to perform decompressive procedures for the treatment of various lumbar spinal conditions.

Source page: https://510kreport.com/device/K253523
Methodology: https://510kreport.com/methodology