510(k) · Cleared
ClearedSpinerx-LDM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinerx Technology · ITH Equipment, Traction, Powered
Cleared on Oct 31, 2003 as substantially equivalent to K951622 (Vat-Tech, Inc., 1996) and 3 other predicates after a 137-day review. Its family tree reaches back 3 generations to 1989. 9 later devices descend from it.
- Decided
- Oct 31, 2003
- Review
- 137 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K894435 (1989). 6 ancestors in all, the oldest K844385 (1985). 9 later devices descend from it, 1 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 backK981822 DRS SystemProfessional Distribution Systems, Inc. · 1998
- This deviceK031862 Spinerx-LDMSpinerx Technology · 2003
- Descendant · cites it directly · 8 of its ownK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
- Descendant · 2 generations on · 1 of its ownK151640 Eltrac 471Enraf-Nonius, B.V. · 2015
- Descendant · 2 generations on · 0 of its ownK214037 Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK222912 c1TracZimmer Medizinsysteme GmbH · 2023
- Descendant · 2 generations on · 0 of its ownK150695 ModpodHollywog, LLC · 2015
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006 · cites it directly8descendants
- K151640Eltrac 471Enraf-Nonius, B.V. · 2015 · 2 generations on1descendant
- K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024 · 2 generations on0descendants
- K222912c1TracZimmer Medizinsysteme GmbH · 2023 · 3 generations on0descendants
- K150695ModpodHollywog, LLC · 2015 · 2 generations on0descendants
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 | K981822 | DRS System | Professional Distribution Systems, Inc. | 1998 | — |
| 0 (this device) | K031862 | Spinerx-LDM | Spinerx Technology | 2003 | — |
| +1 | K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | Chattanooga Group | 2006 | — |
| +2 | K151640 | Eltrac 471 | Enraf-Nonius, B.V. | 2015 | — |
| +2 | K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | 2024 | — |
| +3 | K222912 | c1Trac | Zimmer Medizinsysteme GmbH | 2023 | — |
| +2 | K150695 | Modpod | Hollywog, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (4)
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 |
|---|---|---|---|
| * | K951622 | Vax-D Therapeutic TableSummary page 1…chnological Considerations: The SpineRx - LDM (lumbar decompression machine) combines proven characteristics of several predicate devices. The VAX-D 0Therapeutic Table (K95 1622) effectively applies decompression (distraction) in the prone modality. The DRS System TM (K98 1822) applies variable angle (abov… | 1996 |
| * | K981822 | DRS SystemSummary page 1…teristics of several predicate devices. The VAX-D 0Therapeutic Table (K95 1622) effectively applies decompression (distraction) in the prone modality. The DRS System TM (K98 1822) applies variable angle (above horizontal) decompression (distraction) in the supine modality. The 3D ActiveTrac (K001712) applie… | 1998 |
| * | K001712 | 3D ActivetracSummary page 1…ion) in the prone modality. The DRS System TM (K98 1822) applies variable angle (above horizontal) decompression (distraction) in the supine modality. The 3D ActiveTrac (K001712) applies variable angle (above and below horizontal) decompression (distraction). The SpineRx - LDM provides variable angle decom… | 2000 |
| * | K862846 | Tec Vari-Trac II Traction UnitSummary page 1…range of selectable functions, force levels and time cycles. Prescribed treatnient parameters are selected for each patient and each treatment session. The Vari-Trac il (K862846) has demonstrated the ability to effectively apply traction (distraction) forces in a wide variety of programmable patterns and c… | 1986 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | 2006 | 8 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K053223 (Chattanooga Group, 2006) has gone furthest, with 8 descendants of its own.
- 7 other devices also cite its predicate K951622.
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 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…
Read the full statement (140 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031862: Spinerx-LDM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031862
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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