510(k) · Cleared
ClearedExtended HA 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 Apr 2, 2021 as substantially equivalent to K023921 (Smith & Nephew, Inc., 2003) and 1 other predicate after a 17-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Apr 2, 2021
- Review
- 17 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K953397 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK953397 Hex-Fix Field FixatorSmith & Nephew Richards, Inc. · 1995
- 3 generations backK023134 Jet-X Tin Coated Half PinsSmith & Nephew, Inc. · 2002
- 2 generations backK023921 Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK033289 Modification to Jet-X HA Coated Half PinsSmith & Nephew, Inc. · 2004
- This deviceK210784 Extended HA Half PinsSmith & Nephew, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953397 | Hex-Fix Field Fixator | Smith & Nephew Richards, Inc. | 1995 | — |
| −3 | K023134 | Jet-X Tin Coated Half Pins | Smith & Nephew, Inc. | 2002 | — |
| −2 | K023921 | Jet-X HA Coated Half Pins | Smith & Nephew, Inc. | 2003 | 27 |
| −1 | K033289 | Modification to Jet-X HA Coated Half Pins | Smith & Nephew, Inc. | 2004 | — |
| 0 (this device) | K210784 | Extended HA Half Pins | Smith & Nephew, Inc. | 2021 | — |
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? (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 |
|---|---|---|---|
| * | K023921 | Jet-X HA Coated Half PinsSummary page 4…Number Smith & Nephew, Jet-X HA Coated Half Pins K023921 February 5, 2003 Inc. (primary predicate) Modification to Jet-X HA Coat… | 2003 |
| * | K033289 | Modification to Jet-X HA Coated Half PinsSummary page 4…Inc. (primary predicate) Modification to Jet-X HA Coated Smith & Nephew, Inc. K033289 January 13, 2004 Half Pins Device Description Subject of this premarket notification is th… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 5 other devices also cite its predicate K023921.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
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 Extended HA Half Pins are intended to be used with an external fixation system for fixation of fractures of long bones, joint fusions, and limb lengthening or deformity corrections that involve cutting of the bone and temporary stabilization for the indications listed below.
1. Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction
2. Open and closed fracture fixation
3. Pseudarthrosis of long bones
4. Limb lengthening by distraction
5. Correction of bony or soft tissue deformities
6. Joint arthrodesis
7. Infected fractures
8. Nonunions
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/K210784 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210784: Extended HA 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/K210784
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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