# K030060: Spinemed

- Pathway: 510(k) (Traditional)
- Applicant: Cert Health Sciences, LLC
- Decided: Feb 5, 2003 after 29 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). 5 ancestors in all.
10 later devices descend from it; 2 cite 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)
- K981822: DRS System, Professional Distribution Systems, Inc. (1998) Summary page 1.
- K002260: Spina System, North American Medical Corporation (Nam) (2000) Summary page 2.

## 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 SpineMEDTM provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment session consists of a physician prescribed treatment period on the SpineMEDTM and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain or sciatica. It relieves pain associated with herniated discs, bulging or protruding discs, degenerative disc disease, posterior facet syndrome, and sciatica. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.

Source page: https://510kreport.com/device/K030060
Methodology: https://510kreport.com/methodology