510(k) · Cleared
ClearedCerclage Cable with Hex Button
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · JDQ Cerclage, Fixation
Cleared on Dec 19, 1997 after a 58-day review. The FDA summary names its predicate without a number. 24 later devices descend from it.
- Decided
- Dec 19, 1997
- Review
- 58 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 0
24 later devices descend from it, 3 citing it directly.
- This deviceK974016 Cerclage Cable with Hex ButtonPioneer Surgical Technology · 1997
- Descendant · cites it directly · 10 of its ownK031162 Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 10 of its ownK992617 Hex ButtonPioneer Surgical Technology · 1999
- Descendant · 2 generations on · 7 of its ownK091799 Cable Ready Cable Grip System Cable ButtonZimmer, Inc. · 2009
- Descendant · 3 generations on · 6 of its ownK120772 NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button…Zimmer GmbH · 2012 · Recalled
- Descendant · 2 generations on · 3 of its ownK203405 EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K031162Smith & Nephew Orthopaedic Cabling SystemSmith & Nephew, Inc. · 2003 · cites it directly10descendants
- K992617Hex ButtonPioneer Surgical Technology · 1999 · cites it directly10descendants
- K091799Cable Ready Cable Grip System Cable ButtonZimmer, Inc. · 2009 · 2 generations on7descendants
- K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH · 2012 · 3 generations on6descendants
- K203405EVOS Large Fragment Plating SystemSmith & Nephew, Inc. · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974016 | Cerclage Cable with Hex Button | Pioneer Surgical Technology | 1997 | — |
| +1 | K031162 | Smith & Nephew Orthopaedic Cabling System | Smith & Nephew, Inc. | 2003 | — |
| +1 | K992617 | Hex Button | Pioneer Surgical Technology | 1999 | — |
| +2 | K091799 | Cable Ready Cable Grip System Cable Button | Zimmer, Inc. | 2009 | — |
| +3 | K120772 | NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB… | Zimmer GmbH | 2012 | 2 |
| +2 | K203405 | EVOS Large Fragment Plating System | Smith & Nephew, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Dall-Miles Broad Bone Plate Named without a submission number | |
| * | — | Pioneer Laboratories Bone Plate with Cerclage Cable Named without a submission number | |
| * | — | Bone Plate with Cable Named without a submission number |
What descends from it? (24)
See all 243 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, K031162 (Smith & Nephew, Inc., 2003) 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 | — |
What is it indicated for?
The Cerclage Cable with Hex Button device is indicated for use where wire, cable, or band cerclage is used in combination with plates. The Cerclage Cable with Hex Button device is intended for long bone fractures and is to be used with commercially available bone screws of the same general material type as the plate.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974016 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974016: Cerclage Cable with Hex Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974016
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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