510(k) · Cleared
ClearedIntegrity Spinal Care System 3.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integrity Life Sciences · ITH Equipment, Traction, Powered
Cleared on Feb 6, 2014 as substantially equivalent to K060735 (Axiom Worldwide, Inc., 2006) after a 370-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Feb 6, 2014
- Review
- 370 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894435 (1989). 7 ancestors in all, the oldest K844385 (1985). No later device cites it as a predicate yet.
- Root · 4 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 3 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 2 generations backK022602 DRX3000Axiom Usa., Inc. · 2003
- 1 generation backK060735 DRX9000 True Spinal Decompression SystemAxiom Worldwide, Inc. · 2006
- This deviceK130249 Integrity Spinal Care System 3.0Integrity Life Sciences · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −3 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| −2 | K022602 | DRX3000 | Axiom Usa., Inc. | 2003 | — |
| −1 | K060735 | DRX9000 True Spinal Decompression System | Axiom Worldwide, Inc. | 2006 | — |
| 0 (this device) | K130249 | Integrity Spinal Care System 3.0 | Integrity Life Sciences | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060735 | DRX9000 True Spinal Decompression SystemSummary page 1…gistration Number DRX9000 True Non Axiom Worldwide, Class II/ITH K060735 Surgical LLC. Decompression System ___________________… | 2006 |
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.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.9 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K060735.
How does its category compare?
All ITH devicesITH Equipment, Traction, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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 Integrity Spinal Care System 3.0 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130249: Integrity Spinal Care System 3.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130249
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026