510(k) · Cleared
ClearedTitanium Alloy 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 Apr 8, 1992 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Apr 8, 1992
- Review
- 84 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 3 citing it directly.
- This deviceK920201 Titanium Alloy Songer Cable SystemSofamor Danek Mfg., Inc. · 1992
- Descendant · cites it directly · 7 of its ownK143716 DSM Biomedical DPR CableDsm Biomedical · 2015
- Descendant · 2 generations on · 5 of its ownK170206 Arthrex FiberTape CerclageArthrex, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK232755 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK230976 Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK260018 Arthrex FiberButtonArthrex, Inc. · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K143716DSM Biomedical DPR CableDsm Biomedical · 2015 · cites it directly7descendants
- K170206Arthrex FiberTape CerclageArthrex, Inc. · 2017 · 2 generations on5descendants
- K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2023 · 3 generations on2descendants
- K230976Arthrex Radiopaque FiberTape Cerclage suturesArthrex, Inc. · 2023 · 2 generations on1descendant
- K260018Arthrex FiberButtonArthrex, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K920201 | Titanium Alloy Songer Cable System | Sofamor Danek Mfg., Inc. | 1992 | — |
| +1 | K143716 | DSM Biomedical DPR Cable | Dsm Biomedical | 2015 | — |
| +2 | K170206 | Arthrex FiberTape Cerclage | Arthrex, Inc. | 2017 | — |
| +3 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023 | — |
| +2 | K230976 | Arthrex Radiopaque FiberTape Cerclage sutures | Arthrex, Inc. | 2023 | — |
| +3 | K260018 | Arthrex FiberButton | Arthrex, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 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? (10)
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, K143716 (Dsm Biomedical, 2015) has gone furthest, with 7 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/K920201 · printed Nov 6, 2026
Cite this page
510(k) Report. “K920201: Titanium Alloy 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/K920201
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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