# K060735: DRX9000 True Spinal Decompression System

- Pathway: 510(k) (Traditional)
- Applicant: Axiom Worldwide, Inc.
- Decided: May 26, 2006 after 67 days
- Product code: ITH (Equipment, Traction, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5900
- 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 K894435 (1989). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022602: DRX3000, Axiom Usa., Inc. (2003) Summary page 1.
- K053503: Vax-D Genesis System (Therapeutic Table), Vax-D Medical Technologies USA, L.C. (2005) Summary page 1.

## Most influential descendants
- K243775: True Non-Surgical Spinal Decompression System (DRX9000-SL) (2025), 0 descendants of its own
- K130249: Integrity Spinal Care System 3.0 (2014), 0 descendants of its own
- K073132: Model D Disc Force (2008), 0 descendants of its own

## Indications for use
The DRX9000 True Non-Surgical Spinal Decompression System provides a primary treatment modality for the management of pain and disability for patients suffering with incapacitating low back pain and sciatica. It is designed to apply spinal decompressive forces to compressive and degenerative injuries of the spine. It has been found to provide relief of pain and symptoms associated with herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome and sciatica.

Source page: https://510kreport.com/device/K060735
Methodology: https://510kreport.com/methodology