510(k) · Cleared
ClearedSpinemed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cert Health Sciences, LLC · ITH Equipment, Traction, Powered
Cleared on Feb 5, 2003 as substantially equivalent to K981822 (Professional Distribution Systems, Inc., 1998) and 1 other predicate after a 29-day review. Its family tree reaches back 3 generations to 1989. 10 later devices descend from it.
- Decided
- Feb 5, 2003
- Review
- 29 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K894435 (1989). 5 ancestors in all, the oldest K844385 (1985). 10 later devices descend from it, 2 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 deviceK030060 SpinemedCert Health Sciences, LLC · 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 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · 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) | K030060 | Spinemed | Cert Health Sciences, LLC | 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 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K981822 | DRS SystemSummary page 1…dicate Device I)liS Systen1 P ro fess io na I Distribution Systems, 1[IC. 510(k): K981822 Device Description: The SpineMEDTnfis a multi-function Hi-Lo traction Table designed to apply distraction forces… | 1998 |
| * | K002260 | Spina SystemSummary page 2…pica1 Characteristics The SpineMEDTMincorporates various principles and working characteristics of the predicate devices, the DRS System (K981822) and the SPINA System (K002260). The SpineMEDTMemploys a unique method of restraining the patient’s body to the Table surface, which has not impacted on, or cha… | 2000 |
What descends from it? (10)
2 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 14 years and passes through 3 companies; a new generation was cleared every 4.6 years on median.
- None of the 5 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 K981822.
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 SpineMEDTM provides a program of treatments for relief from pain for those patients suffering with low back pain. Each treatment session consists of a physician prescribed treatment period on the SpineMEDTM and is designed to provide static, intermittent, and cycling distraction forces to relieve pressures on structures that may be causing low back pain or sciatica. It relieves pain associated with herniated discs, bulging or protruding 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030060: Spinemed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030060
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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