510(k) · Cleared
ClearedCerclage Wire Crimp Sleeve
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acu Med, Inc. · JDQ Cerclage, Fixation
Cleared on Feb 22, 1994 after a 348-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Feb 22, 1994
- Review
- 348 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK931246 Cerclage Wire Crimp SleeveAcu Med, Inc. · 1994
- Descendant · cites it directly · 10 of its ownK101170 Acute Innovations Sternal Fixation SystemAcute Innovations, LLC · 2010
- Descendant · 2 generations on · 8 of its ownK113318 Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · Recalled
- Descendant · 3 generations on · 5 of its ownK141241 Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014
- Descendant · 4 generations on · 4 of its ownK183317 AdvantageRib SystemSig Medical Corporation · 2019
- Descendant · 5 generations on · 3 of its ownK203474 Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K101170Acute Innovations Sternal Fixation SystemAcute Innovations, LLC · 2010 · cites it directly10descendants
- K113318Acute Innovations Modular Ribloc SystemAcute Innovations, LLC · 2012 · 2 generations on8descendants
- K141241Matrixrib Endo Thoracoscopic Rib Plating SystemSynthes (USA) Products, LLC · 2014 · 3 generations on5descendants
- K183317AdvantageRib SystemSig Medical Corporation · 2019 · 4 generations on4descendants
- K203474Biomet Microfixation RibFix Advantage SystemBiomet Micofixation · 2021 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931246 | Cerclage Wire Crimp Sleeve | Acu Med, Inc. | 1994 | — |
| +1 | K101170 | Acute Innovations Sternal Fixation System | Acute Innovations, LLC | 2010 | — |
| +2 | K113318 | Acute Innovations Modular Ribloc System | Acute Innovations, LLC | 2012 | 1 |
| +3 | K141241 | Matrixrib Endo Thoracoscopic Rib Plating System | Synthes (USA) Products, LLC | 2014 | — |
| +4 | K183317 | AdvantageRib System | Sig Medical Corporation | 2019 | — |
| +5 | K203474 | Biomet Microfixation RibFix Advantage System | Biomet Micofixation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 122 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, K101170 (Acute Innovations, LLC, 2010) has gone furthest, with 10 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/K931246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931246: Cerclage Wire Crimp Sleeve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931246
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