510(k) · Cleared
ClearedTriton/Tru-Trac/TX Traction Devices
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chattanooga Group · ITH Equipment, Traction, Powered
Cleared on Sep 21, 2005 after a 65-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 9 later devices descend from it.
- Decided
- Sep 21, 2005
- Review
- 65 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK051938 Triton/Tru-Trac/TX Traction DevicesChattanooga Group · 2005
- 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 · cites it directly · 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051938 | Triton/Tru-Trac/TX Traction Devices | Chattanooga Group | 2005 | — |
| +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 | — |
| +1 | K150695 | Modpod | Hollywog, LLC | 2015 | — |
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 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? (9)
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?
- Of its descendants, K053223 (Chattanooga Group, 2006) has gone furthest, with 8 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 Triton/Tru-Trac/TX traction devices provide traction and mobilization of skeletal structures and skeletal muscles. The Triton/Tru-Trac/TX traction devices provide a treatment in static, intermittent, progressive, regressive and cycling distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of…
Read the full statement (134 words)
The Triton/Tru-Trac/TX traction devices provide traction and mobilization of skeletal structures and skeletal muscles.
The Triton/Tru-Trac/TX traction devices provide a treatment in static, intermittent, progressive, regressive and cycling distraction forces to relieve pressures on structures that may be causing pain of skeletal or muscular origin (cervical, thoracic, lumbar, hip, wrist, shoulder). Therapeutic distraction can be applied in a variety of programmable patterns, cycles and functions.
The Triton/Tru-Trac/TX traction devices may be used to relieve peripheral radiation/sciatica and pain associated with:
Protruding discs
Bulging discs
Herniated discs
Degenerative disc disease
Posterior facet syndrome
Acute facet problems
Radicular pain
Prolapsed discs
Spinal root impingement
Hypomobility
Degenerative joint disease
Facet syndrome
Compressions fractures
Joint pain
Discogenic pain
The Triton/Tru-Trac/TX traction devices achieve 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/K051938 · printed Nov 4, 2026
Cite this page
510(k) Report. “K051938: Triton/Tru-Trac/TX Traction Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K051938
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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