510(k) · Cleared
ClearedSynthes (Usa) 5.0MM/7.3MM Crimp Positioning Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · JDQ Cerclage, Fixation
Cleared on Jul 1, 2008 after a 63-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jul 1, 2008
- Review
- 63 days
- Class
- Class II
- Product code
- JDQ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK081205 Synthes (Usa) 5.0MM/7.3MM Crimp Positioning PinsSynthes (Usa) · 2008
- Descendant · cites it directly · 2 of its ownK172975 DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK243995 Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK260353 Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage…Arthrex, Inc. · 2026
Most influential descendants
Showing 3 of 3 · See all- K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018 · cites it directly2descendants
- K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025 · 2 generations on1descendant
- K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K081205 | Synthes (Usa) 5.0MM/7.3MM Crimp Positioning Pins | Synthes (Usa) | 2008 | — |
| +1 | K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional… | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018 | — |
| +2 | K243995 | Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. | 2025 | — |
| +3 | K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | — | Synthes Cerclage Positioning Pin Named without a submission number | |
| * | — | Pioneer Surgical Technology Hex Button Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes… | 2018 | 2 |
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, K172975 (Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc., 2018) has gone furthest, with 2 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. 2008, 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?
The Synthes 5.0mm and 7.3mm Crimp Positioning Pins are intended for use with multifilament cable to augment fracture stabilization with plates used in long bone fixation when the use of screws is contraindicated, as in the presence of intramedullary implants.
The 5.0mm Crimp Positioning Pins are designed for use in the 5.0mm locking or 4.5mm LCP holes of Synthes plates. The 7.3mm Crimp Positioning Pins are designed for use in the 7.3mm locking holes of Synthes plates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081205 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081205: Synthes (Usa) 5.0MM/7.3MM Crimp Positioning Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081205
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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