510(k) · Cleared
ClearedDRX9000 True Spinal Decompression System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axiom Worldwide, Inc. · ITH Equipment, Traction, Powered
Cleared on May 26, 2006 as substantially equivalent to K022602 (Axiom Usa., Inc., 2003) and 1 other predicate after a 67-day review. Its family tree reaches back 3 generations to 1989. 3 later devices descend from it.
- Decided
- May 26, 2006
- Review
- 67 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K894435 (1989). 6 ancestors in all, the oldest K844385 (1985). 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK894435 Vax-T Pelvic Traction BeltVat-Tech, Inc. · 1989
- 2 generations backK951622 Vax-D Therapeutic TableVat-Tech, Inc. · 1996
- 1 generation backK022602 DRX3000Axiom Usa., Inc. · 2003
- This deviceK060735 DRX9000 True Spinal Decompression SystemAxiom Worldwide, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK243775 True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC · 2025
- Descendant · cites it directly · 0 of its ownK130249 Integrity Spinal Care System 3.0Integrity Life Sciences · 2014
- Descendant · cites it directly · 0 of its ownK073132 Model D Disc ForceNorth American Medical Corp (Nam) · 2008
Most influential descendants
Showing 3 of 3 · See all- K243775True Non-Surgical Spinal Decompression System (DRX9000-SL)Excite Medical of Tampa Bay, LLC · 2025 · cites it directly0descendants
- K130249Integrity Spinal Care System 3.0Integrity Life Sciences · 2014 · cites it directly0descendants
- K073132Model D Disc ForceNorth American Medical Corp (Nam) · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894435 | Vax-T Pelvic Traction Belt | Vat-Tech, Inc. | 1989 | — |
| −2 | K951622 | Vax-D Therapeutic Table | Vat-Tech, Inc. | 1996 | — |
| −1 | K022602 | DRX3000 | Axiom Usa., Inc. | 2003 | — |
| 0 (this device) | K060735 | DRX9000 True Spinal Decompression System | Axiom Worldwide, Inc. | 2006 | — |
| +1 | K243775 | True Non-Surgical Spinal Decompression System (DRX9000-SL) | Excite Medical of Tampa Bay, LLC | 2025 | — |
| +1 | K130249 | Integrity Spinal Care System 3.0 | Integrity Life Sciences | 2014 | — |
| +1 | K073132 | Model D Disc Force | North American Medical Corp (Nam) | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2025 | 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? (2)
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 |
|---|---|---|---|
| * | K022602 | DRX3000Summary page 1…Class and Reference Class 11 (21 CFR Section 890.5900) Product Code: 89 ITH Panel Code: 87 ORS 5. Predicate Devices K022602 DRX3000 - Axiom Worldwide K053503 VAX-D Genesis System - VAX-D Medical Technologies 6. Device Description… | 2003 |
| * | K053503 | Vax-D Genesis System (Therapeutic Table)Summary page 1…ection 890.5900) Product Code: 89 ITH Panel Code: 87 ORS 5. Predicate Devices K022602 DRX3000 - Axiom Worldwide K053503 VAX-D Genesis System - VAX-D Medical Technologies 6. Device Description The DRX9000 True Non-Surgical Spinal Decom… | 2005 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 17 years and passes through 3 companies; a new generation was cleared every 6.6 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K243775 (Excite Medical of Tampa Bay, LLC, 2025) has gone furthest, with 0 descendants of its own.
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 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060735 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060735: DRX9000 True Spinal Decompression System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060735
Report an extraction error
Are you the manufacturer?
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