510(k) · Cleared
ClearedTitanium Songer Cable System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofamor Danek Mfg., Inc. · JDQ Cerclage, Fixation
Cleared on Mar 24, 1993 after a 132-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 51 later devices descend from it.
- Decided
- Mar 24, 1993
- Review
- 132 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 0
51 later devices descend from it, 2 citing it directly.
- This deviceK925812 Titanium Songer Cable SystemSofamor Danek Mfg., Inc. · 1993
- Descendant · cites it directly · 49 of its ownK974020 Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997
- Descendant · 2 generations on · 48 of its ownK060009 Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006
- Descendant · 3 generations on · 46 of its ownK081622 Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008
- Descendant · 4 generations on · 45 of its ownK091190 Universal Clamp Stainless Steel System, Models SNA027-0-30060…Zimmer Spine, Inc. · 2009
- Descendant · 3 generations on · 44 of its ownK110348 Universal Clamp Spinal Fixation SystemZimmer Spine · 2011
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K974020Spinal Concepts, Inc., Cfix Cable SystemSpinal Concepts, Inc. · 1997 · cites it directly49descendants
- K060009Abbott Spine Universal Clamp SystemAbbott Spine, Inc. · 2006 · 2 generations on48descendants
- K081622Universal Clamp Stainless Steel SystemAbbott Spine, Inc. · 2008 · 3 generations on46descendants
- K091190Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063Zimmer Spine, Inc. · 2009 · 4 generations on45descendants
- K110348Universal Clamp Spinal Fixation SystemZimmer Spine · 2011 · 3 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925812 | Titanium Songer Cable System | Sofamor Danek Mfg., Inc. | 1993 | — |
| +1 | K974020 | Spinal Concepts, Inc., Cfix Cable System | Spinal Concepts, Inc. | 1997 | — |
| +2 | K060009 | Abbott Spine Universal Clamp System | Abbott Spine, Inc. | 2006 | — |
| +3 | K081622 | Universal Clamp Stainless Steel System | Abbott Spine, Inc. | 2008 | — |
| +4 | K091190 | Universal Clamp Stainless Steel System, Models SNA027-0-30060, SNA027-0-30063 | Zimmer Spine, Inc. | 2009 | — |
| +3 | K110348 | Universal Clamp Spinal Fixation System | Zimmer Spine | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 8 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 JDQ? 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 JDQ device
- #1 K261271 Cable-Ready® Cable Grip Systemscore 14.7 · 11 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? (51)
See all 512 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, K974020 (Spinal Concepts, Inc., 1997) has gone furthest, with 49 descendants of its own.
How does its category compare?
All JDQ devicesJDQ Cerclage, Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDQ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDQ
130in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JDQ
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDQ
84in 2025
MAUDE reports naming product code JDQ, 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 | 1 | — | 0 | 5 |
| 2008 | 2 | — | 2 | 25 |
| 2009 | 2 | — | 0 | 19 |
| 2010 | 0 | — | 2 | 28 |
| 2011 | 6 | 130 | 0 | 30 |
| 2012 | 3 | 134 | 0 | 130 |
| 2013 | 1 | — | 1 | 321 |
| 2014 | 2 | — | 0 | 223 |
| 2015 | 5 | 92 | 1 | 205 |
| 2016 | 4 | 129 | 0 | 224 |
| 2017 | 1 | — | 0 | 138 |
| 2018 | 6 | 101 | 0 | 182 |
| 2019 | 0 | — | 5 | 158 |
| 2020 | 4 | 93 | 0 | 125 |
| 2021 | 0 | — | 0 | 141 |
| 2022 | 2 | — | 0 | 134 |
| 2023 | 3 | 141 | 0 | 98 |
| 2024 | 3 | 130 | 0 | 115 |
| 2025 | 2 | — | 0 | 84 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K925812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K925812: Titanium Songer Cable System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925812
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026