510(k) · Cleared
ClearedThreaded Fixation Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthopaedic Biosystems, Ltd. · JDW Pin, Fixation, Threaded
Cleared on Nov 6, 1996 after a 68-day review. The FDA summary names its predicate without a number. 317 later devices descend from it.
- Decided
- Nov 6, 1996
- Review
- 68 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 0
317 later devices descend from it, 2 citing it directly.
- This deviceK963433 Threaded Fixation PinOrthopaedic Biosystems, Ltd. · 1996
- Descendant · cites it directly · 310 of its ownK062863 Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006
- Descendant · 2 generations on · 219 of its ownK103705 Low Profile ScrewsArthrex, Inc. · 2011
- Descendant · 3 generations on · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- Descendant · 3 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- Descendant · 3 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
Showing 5 of 317 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 317 · See all- K062863Osteomed Extended 2.0/2.4CANNULATED Screw SystemOsteomed LP · 2006 · cites it directly310descendants
- K103705Low Profile ScrewsArthrex, Inc. · 2011 · 2 generations on219descendants
- K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · 3 generations on135descendants
- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 3 generations on91descendants
- K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · 3 generations on71descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963433 | Threaded Fixation Pin | Orthopaedic Biosystems, Ltd. | 1996 | — |
| +1 | K062863 | Osteomed Extended 2.0/2.4CANNULATED Screw System | Osteomed LP | 2006 | — |
| +2 | K103705 | Low Profile Screws | Arthrex, Inc. | 2011 | — |
| +3 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| +3 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| +3 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 10 | 0 |
| 2014 | 18 | 0 |
| 2015 | 24 | 0 |
| 2016 | 8 | 0 |
| 2017 | 31 | 0 |
| 2018 | 14 | 0 |
| 2019 | 16 | 0 |
| 2020 | 22 | 0 |
| 2021 | 23 | 0 |
| 2022 | 22 | 0 |
| 2023 | 21 | 0 |
| 2024 | 24 | 0 |
| 2025 | 26 | 0 |
| 2026 | 37 | 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 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? (1)
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 Threaded Kirschner Wires Named without a submission number |
What descends from it? (317)
See all 3172 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, K062863 (Osteomed LP, 2006) has gone furthest, with 310 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 | — |
What is it indicated for?
Both function as internal alignment and fixation for small bones of the hand and foot
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/K963433 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963433: Threaded Fixation Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963433
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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