510(k) · Cleared
ClearedSpina System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North American Medical Corp (Nam) · ITH Equipment, Traction, Powered
Cleared on Sep 9, 2005 after a 704-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 9, 2005
- Review
- 704 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ITH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ITH device
- #1 K243775 True Non-Surgical Spinal Decompression System…score 10.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ITH
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ITH
132in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ITH
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ITH
3in 2025
MAUDE reports naming product code ITH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 2 |
| 2008 | 4 | 132 | 0 | 0 |
| 2009 | 1 | — | 0 | 3 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 1 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 5 |
| 2025 | 2 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The device provides a program of treatments for relief from pain and disability for those patients suffering with low back pain. A treatment will consist of a physician prescribed treatment period on the device and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated discs, degenerative disc disease, posterior facet…
Read the full statement (137 words)
The device provides a program of treatments for relief from pain and disability for those patients suffering with low back pain. A treatment will consist of a physician prescribed treatment period on the device and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain. It relieves pain associated with herniated 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.
The SPINA SYSTEM CERVICAL also offers a cervical accessory which provides a program of treatments for relief from neck pain associated with herniated discs, degenerative disc disease, and posterior facet syndrome. It achieves these effects through decompression of intervertebral discs, that is, unloading due to distraction and positioning.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033231: Spina System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033231
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026