510(k) · Cleared
ClearedIso-Elastic Cerclage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinamed, Inc. · JDQ Cerclage, Fixation
Cleared on Oct 21, 2003 after a 270-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Oct 21, 2003
- Review
- 270 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK030256 Iso-Elastic Cerclage SystemKinamed, Inc. · 2003
- Descendant · cites it directly · 1 of its ownK181749 SuperCable® Iso-Elastic™ Cerclage SystemKinamed, Incorporated · 2018
- Descendant · cites it directly · 1 of its ownK063009 Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None…Praesidia S.R.L. · 2006
- Descendant · 2 generations on · 0 of its ownK243344 Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque…Arthrex, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK090686 Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009
Most influential descendants
Showing 4 of 4 · See all- K181749SuperCable® Iso-Elastic™ Cerclage SystemKinamed, Incorporated · 2018 · cites it directly1descendant
- K063009Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes)Praesidia S.R.L. · 2006 · cites it directly1descendant
- K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc. · 2025 · 2 generations on0descendants
- K090686Sic Brevetti S.R.L. Device for Sternal SynthesisSic Brevetti S.R.L. · 2009 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K030256 | Iso-Elastic Cerclage System | Kinamed, Inc. | 2003 | — |
| +1 | K181749 | SuperCable® Iso-Elastic™ Cerclage System | Kinamed, Incorporated | 2018 | — |
| +1 | K063009 | Flexigrip Sternal Closure System, Model FG0200 Through FG0400 (None Sizes) | Praesidia S.R.L. | 2006 | — |
| +2 | K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape… | Arthrex, Inc. | 2025 | — |
| +2 | K090686 | Sic Brevetti S.R.L. Device for Sternal Synthesis | Sic Brevetti S.R.L. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2018 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), 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’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
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?
- Of its descendants, K181749 (Kinamed, Incorporated, 2018) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
a. Repair of long bone fractures due to trauma or reconstruction;
b. reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy;
c. sternotomy closure; and
d. sublaminar and intrafacet wiring of the spinal column.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K030256 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030256: Iso-Elastic Cerclage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030256
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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