510(k) · Cleared
ClearedSpina System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
North American Medical Corporation (Nam) · ITH Equipment, Traction, Powered
Cleared on Aug 25, 2000 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- Aug 25, 2000
- Review
- 31 days
- Class
- Class II
- Product code
- ITH
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK002260 Spina SystemNorth American Medical Corporation (Nam) · 2000
- Descendant · cites it directly · 10 of its ownK030060 SpinemedCert Health Sciences, LLC · 2003
- Descendant · 2 generations on · 8 of its ownK053223 Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006
- Descendant · 3 generations on · 1 of its ownK151640 Eltrac 471Enraf-Nonius, B.V. · 2015
- Descendant · 3 generations on · 0 of its ownK214037 Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024
- Descendant · 4 generations on · 0 of its ownK222912 c1TracZimmer Medizinsysteme GmbH · 2023
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K030060SpinemedCert Health Sciences, LLC · 2003 · cites it directly10descendants
- K053223Triton/Tru-Trac/TX/Triton DTS TractionChattanooga Group · 2006 · 2 generations on8descendants
- K151640Eltrac 471Enraf-Nonius, B.V. · 2015 · 3 generations on1descendant
- K214037Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-TracErgo-Flex Technologies, LLC · 2024 · 3 generations on0descendants
- K222912c1TracZimmer Medizinsysteme GmbH · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002260 | Spina System | North American Medical Corporation (Nam) | 2000 | — |
| +1 | K030060 | Spinemed | Cert Health Sciences, LLC | 2003 | — |
| +2 | K053223 | Triton/Tru-Trac/TX/Triton DTS Traction | Chattanooga Group | 2006 | — |
| +3 | K151640 | Eltrac 471 | Enraf-Nonius, B.V. | 2015 | — |
| +3 | K214037 | Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac | Ergo-Flex Technologies, LLC | 2024 | — |
| +4 | K222912 | c1Trac | Zimmer Medizinsysteme GmbH | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 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), 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 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, K030060 (Cert Health Sciences, LLC, 2003) has gone furthest, with 10 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 | — |
https://510kreport.com/device/K002260 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002260: Spina System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002260
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026