510(k) · Cleared
Recalled · 2012Jet-X HA Coated Half Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · JDW Pin, Fixation, Threaded
Cleared on Feb 5, 2003 as substantially equivalent to K023134 (Smith & Nephew, Inc., 2002) after a 72-day review. Its family tree reaches back 2 generations to 1995. 50 later devices descend from it. It has been recalled 27 times.
- Decided
- Feb 5, 2003
- Review
- 72 days
- Class
- Class II
- Product code
- JDW
- Recalls
- 27
- Predicates
- 1
Its longest line of descent runs back 2 generations to K953397 (1995). 50 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK953397 Hex-Fix Field FixatorSmith & Nephew Richards, Inc. · 1995
- 1 generation backK023134 Jet-X Tin Coated Half PinsSmith & Nephew, Inc. · 2002
- This deviceK023921 Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2003
- Descendant · cites it directly · 49 of its ownK033289 Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2004
- Descendant · cites it directly · 34 of its ownK050849 HA Coated Lag ScrewSmith & Nephew, Inc. · 2005
- Descendant · 2 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · 3 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K033289Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2004 · cites it directly49descendants
- K050849HA Coated Lag ScrewSmith & Nephew, Inc. · 2005 · cites it directly34descendants
- K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on33descendants
- K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 3 generations on32descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 4 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K953397 | Hex-Fix Field Fixator | Smith & Nephew Richards, Inc. | 1995 | — |
| −1 | K023134 | Jet-X Tin Coated Half Pins | Smith & Nephew, Inc. | 2002 | — |
| 0 (this device) | K023921 | Jet-X HA Coated Half Pins | Smith & Nephew, Inc. | 2003 | — |
| +1 | K033289 | Modification to Jet-X HA Coated Half Pins | Smith & Nephew, Inc. | 2004 | — |
| +1 | K050849 | HA Coated Lag Screw | Smith & Nephew, Inc. | 2005 | — |
| +2 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +3 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +4 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 8 | 0 |
| 2025 | 12 | 0 |
| 2026 | 5 | 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.
What descends from it? (50)
See all 506 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033289 | Modification to Jet-X HA Coated Half Pins | 2004 | 49 |
| K050849 | HA Coated Lag Screw | 2005 | 34 |
| K120871 | Smith & Nephew, Inc. External Fixation System Instrumentation | 2012 | 6 |
| K201253 | Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV… | 2020 | 5 |
| K132820 | Vilex Ultima External Fixation System with HA Coated Pins and Wires | 2014 | 5 |
| K210784 | Extended HA Half Pins | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 13, 2012 | Not classified | Z-1727-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1744-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1736-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1737-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1770-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1741-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1739-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1742-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1743-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1771-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1728-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1738-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1733-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1768-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1732-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1731-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1725-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1745-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1730-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1769-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1726-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1734-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1729-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1740-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1746-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1767-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Apr 13, 2012 | Not classified | Z-1772-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
The 5 latest of 27 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K033289 (Smith & Nephew, Inc., 2004) has gone furthest, with 49 descendants of its own.
- 2 other devices also cite its predicate K023134.
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?
The Jet-X HA Coated Half Pin is intended to be used with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or nonunion of long bones; limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023921 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023921: Jet-X HA Coated Half Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023921
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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