510(k) · Cleared
ClearedRush Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Onyx Medical Corp. · JDW Pin, Fixation, Threaded
Cleared on Jul 30, 1990 after a 6-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Jul 30, 1990
- Review
- 6 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 2 citing it directly.
- This deviceK903261 Rush PinOnyx Medical Corp. · 1990
- Descendant · cites it directly · 8 of its ownK110895 Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011
- Descendant · 2 generations on · 3 of its ownK163489 OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · Recalled
- Descendant · 2 generations on · 2 of its ownK150889 Suture Wires and Wire LoopsZimmer, Inc. · 2015
- Descendant · 3 generations on · 1 of its ownK203773 BRM TOOL ScrewsBrm Extremities Srl · 2022
- Descendant · 3 generations on · 1 of its ownK151848 Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready…Zimmer, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K110895Ortho Solutions Trauma Implants for OsteosynthesisOrtho Solutions Limited · 2011 · cites it directly8descendants
- K163489OrthoSolutions 'System26' Bone ScrewsOrtho Solutions UK Limited · 2017 · 2 generations on3descendants
- K150889Suture Wires and Wire LoopsZimmer, Inc. · 2015 · 2 generations on2descendants
- K203773BRM TOOL ScrewsBrm Extremities Srl · 2022 · 3 generations on1descendant
- K151848Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle SystemZimmer, Inc. · 2016 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K903261 | Rush Pin | Onyx Medical Corp. | 1990 | — |
| +1 | K110895 | Ortho Solutions Trauma Implants for Osteosynthesis | Ortho Solutions Limited | 2011 | — |
| +2 | K163489 | OrthoSolutions 'System26' Bone Screws | Ortho Solutions UK Limited | 2017 | 1 |
| +2 | K150889 | Suture Wires and Wire Loops | Zimmer, Inc. | 2015 | — |
| +3 | K203773 | BRM TOOL Screws | Brm Extremities Srl | 2022 | — |
| +3 | K151848 | Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle… | Zimmer, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 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 JDW? 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 JDW device
- #1 K260073 XT3 System; XT3 System, Mini; XT3 System…score 15.0 · 15 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? (10)
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, K110895 (Ortho Solutions Limited, 2011) has gone furthest, with 8 descendants of its own.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JDW
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JDW
Too few JDW 510(k)s in any year since 2007 to give a median.
Recalls per year · JDW
21in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDW
29in 2025
MAUDE reports naming product code JDW, 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 | 2 | — | 0 | 25 |
| 2008 | 0 | — | 0 | 26 |
| 2009 | 1 | — | 2 | 29 |
| 2010 | 2 | — | 2 | 29 |
| 2011 | 1 | — | 0 | 55 |
| 2012 | 1 | — | 52 | 75 |
| 2013 | 2 | — | 0 | 69 |
| 2014 | 2 | — | 0 | 27 |
| 2015 | 1 | — | 0 | 70 |
| 2016 | 0 | — | 0 | 46 |
| 2017 | 1 | — | 2 | 43 |
| 2018 | 1 | — | 21 | 94 |
| 2019 | 1 | — | 0 | 575 |
| 2020 | 2 | — | 0 | 402 |
| 2021 | 2 | — | 0 | 168 |
| 2022 | 2 | — | 0 | 121 |
| 2023 | 0 | — | 0 | 72 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 2 | — | 0 | 29 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K903261 · printed Nov 4, 2026
Cite this page
510(k) Report. “K903261: Rush Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K903261
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026