510(k) · Cleared
ClearedHagie Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O'Tec Corp. · JDW Pin, Fixation, Threaded
Cleared on Jan 4, 1991 after a 37-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it.
- Decided
- Jan 4, 1991
- Review
- 37 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK905347 Hagie PinO'Tec Corp. · 1991
- Descendant · cites it directly · 15 of its ownK991649 Depuy Rockwood Clavicle PinDepuy, Inc. · 1999
- Descendant · 2 generations on · 7 of its ownK103001 Rockwood Clavicle PinsDePuy Orthopaedics, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK081832 Ensplintcmx Clavicle PinSonoma Orthopedic Products, Inc. · 2008
- Descendant · 3 generations on · 2 of its ownK143204 AOS Clavicle Intramedullary DeviceAdvanced Orthopaedic Solutions, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK130298 Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K991649Depuy Rockwood Clavicle PinDepuy, Inc. · 1999 · cites it directly15descendants
- K103001Rockwood Clavicle PinsDePuy Orthopaedics, Inc. · 2011 · 2 generations on7descendants
- K081832Ensplintcmx Clavicle PinSonoma Orthopedic Products, Inc. · 2008 · 2 generations on4descendants
- K143204AOS Clavicle Intramedullary DeviceAdvanced Orthopaedic Solutions, Inc. · 2015 · 3 generations on2descendants
- K130298Biopro Kwick-Wire Universal Screw SystemBiopro, Inc. · 2013 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K905347 | Hagie Pin | O'Tec Corp. | 1991 | — |
| +1 | K991649 | Depuy Rockwood Clavicle Pin | Depuy, Inc. | 1999 | — |
| +2 | K103001 | Rockwood Clavicle Pins | DePuy Orthopaedics, Inc. | 2011 | — |
| +2 | K081832 | Ensplintcmx Clavicle Pin | Sonoma Orthopedic Products, Inc. | 2008 | — |
| +3 | K143204 | AOS Clavicle Intramedullary Device | Advanced Orthopaedic Solutions, Inc. | 2015 | — |
| +2 | K130298 | Biopro Kwick-Wire Universal Screw System | Biopro, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2025 | 2 | 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? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991649 | Depuy Rockwood Clavicle Pin | 1999 | 15 |
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, K991649 (Depuy, Inc., 1999) has gone furthest, with 15 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/K905347 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905347: Hagie Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905347
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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