# K031862: Spinerx-LDM

- Pathway: 510(k) (Traditional)
- Applicant: Spinerx Technology
- Decided: Oct 31, 2003 after 137 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.
9 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951622: Vax-D Therapeutic Table, Vat-Tech, Inc. (1996) Summary page 1.
- K981822: DRS System, Professional Distribution Systems, Inc. (1998) Summary page 1.
- K001712: 3D Activetrac, The Saunders Group (2000) Summary page 1.
- K862846: Tec Vari-Trac II Traction Unit, Therapeutic Equipment Corp. (1986) Summary page 1.

## Most influential descendants
- K053223: Triton/Tru-Trac/TX/Triton DTS Traction (2006), 8 descendants of its own
- K151640: Eltrac 471 (2015), 1 descendant of its own
- K214037: Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac (2024), 0 descendants of its own
- K222912: c1Trac (2023), 0 descendants of its own
- K150695: Modpod (2015), 0 descendants of its own

## Indications for use
The SpineRx - LDM, Lumbar Decompression Machine, is intended to provide a variety of treatment options for patients who suffer from some of the most common forms of low back pain. Conditions which may be treated include bulging or protruding discs, herniated discs, degenerative disc disease, posterior facet syndrome and sciatica. The SpineRx - LDM can apply therapeutic decompression (distraction) force to relieve pressure on structures which may produce pain. Decompression can relieve pain by introducing a distraction force (unloading) sufficient to reduce intradiscal pressure and impingement. Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions. Variable angle positioning in either supine or prone modalities acts to concentrate decompression forces for optimum results. This machine is a prescription device and as such, it should be used under the direct supervision of a qualified medical professional.

Source page: https://510kreport.com/device/K031862
Methodology: https://510kreport.com/methodology