510(k) · Cleared
ClearedKirschner Orthopedic Wire, Eyelet Cerclage Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kirschner Medical Corp. · JDQ Cerclage, Fixation
Cleared on May 1, 1985 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 48 later devices descend from it.
- Decided
- May 1, 1985
- Review
- 71 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 0
48 later devices descend from it, 3 citing it directly.
- This deviceK850631 Kirschner Orthopedic Wire, Eyelet Cerclage WiresKirschner Medical Corp. · 1985
- Descendant · cites it directly · 43 of its ownK032534 Synthes AfsSynthes Spine · 2004
- Descendant · cites it directly · 31 of its ownK050082 Centerpiece Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2005
- Descendant · 2 generations on · 17 of its ownK091994 Mountaineer Laminoplasty SystemDepuy Spine, Inc. · 2010
- Descendant · 2 generations on · 17 of its ownK043338 Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc. · 2005
- Descendant · 2 generations on · 11 of its ownK080664 Relieve Laminoplasty Fixation SystemGlobus Medical, Inc. · 2008
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K032534Synthes AfsSynthes Spine · 2004 · cites it directly43descendants
- K050082Centerpiece Plate Fixation SystemMedtronic Sofamor Danek, Inc. · 2005 · cites it directly31descendants
- K091994Mountaineer Laminoplasty SystemDepuy Spine, Inc. · 2010 · 2 generations on17descendants
- K043338Blakstone Laminoplasty Fixation SystemBlackstone Medical, Inc. · 2005 · 2 generations on17descendants
- K080664Relieve Laminoplasty Fixation SystemGlobus Medical, Inc. · 2008 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K850631 | Kirschner Orthopedic Wire, Eyelet Cerclage Wires | Kirschner Medical Corp. | 1985 | — |
| +1 | K032534 | Synthes Afs | Synthes Spine | 2004 | — |
| +1 | K050082 | Centerpiece Plate Fixation System | Medtronic Sofamor Danek, Inc. | 2005 | — |
| +2 | K091994 | Mountaineer Laminoplasty System | Depuy Spine, Inc. | 2010 | — |
| +2 | K043338 | Blakstone Laminoplasty Fixation System | Blackstone Medical, Inc. | 2005 | — |
| +2 | K080664 | Relieve Laminoplasty Fixation System | Globus Medical, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2026 | 4 | 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? (48)
See all 483 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, K032534 (Synthes Spine, 2004) has gone furthest, with 43 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/K850631 · printed Nov 4, 2026
Cite this page
510(k) Report. “K850631: Kirschner Orthopedic Wire, Eyelet Cerclage Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K850631
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