510(k) · Cleared
ClearedIso-Elastic Cerclage System (1MM and 2MM Cable Diameter)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kinamed, Incorporated · JDQ Cerclage, Fixation
Cleared on Jan 12, 2011 after a 105-day review. The FDA summary names no predicate by number. 6 later devices descend from it.
- Decided
- Jan 12, 2011
- Review
- 105 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK102834 Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter)Kinamed, Incorporated · 2011
- Descendant · cites it directly · 5 of its ownK170206 Arthrex FiberTape CerclageArthrex, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK232755 Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK260018 Arthrex FiberButtonArthrex, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK243344 Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque…Arthrex, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK243742 Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170206Arthrex FiberTape CerclageArthrex, Inc. · 2017 · cites it directly5descendants
- K232755Arthrex FiberTape and TigerTape Cerclage SuturesArthrex, Inc. · 2023 · 2 generations on2descendants
- K260018Arthrex FiberButtonArthrex, Inc. · 2026 · 2 generations on0descendants
- K243344Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage…Arthrex, Inc. · 2025 · 3 generations on0descendants
- K243742Arthrex DynaNite Nitinol StaplesArthrex, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K102834 | Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter) | Kinamed, Incorporated | 2011 | — |
| +1 | K170206 | Arthrex FiberTape Cerclage | Arthrex, Inc. | 2017 | — |
| +2 | K232755 | Arthrex FiberTape and TigerTape Cerclage Sutures | Arthrex, Inc. | 2023 | — |
| +2 | K260018 | Arthrex FiberButton | Arthrex, Inc. | 2026 | — |
| +3 | K243344 | Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape… | Arthrex, Inc. | 2025 | — |
| +3 | K243742 | Arthrex DynaNite Nitinol Staples | Arthrex, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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?
The FDA summary names no predicate by number.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170206 | Arthrex FiberTape Cerclage | 2017 | 5 |
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, K170206 (Arthrex, Inc., 2017) has gone furthest, with 5 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. 2011, this device’s year, is highlighted.
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 summary.
https://510kreport.com/device/K102834 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102834: Iso-Elastic Cerclage System (1MM and 2MM Cable Diameter).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K102834
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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