510(k) · Cleared
Recalled · 2012Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories]
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 18, 2000 after a 72-day review. The FDA summary names its predicate without a number. 127 later devices descend from it. It has been recalled 19 times.
- Decided
- Feb 18, 2000
- Review
- 72 days
- Class
- Class II
- Product code
- JDW
- Recalls
- 19
- Predicates
- 0
127 later devices descend from it, 19 citing it directly.
- This deviceK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000
- Descendant · cites it directly · 51 of its ownK093047 Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · Recalled
- Descendant · cites it directly · 37 of its ownK070555 Orthopro Steinman Pins and Kirschner WiresOrthopro, LLC · 2007
- Descendant · 2 generations on · 32 of its ownK141078 Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014
- Descendant · 2 generations on · 27 of its ownK113006 I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012
- Descendant · 3 generations on · 26 of its ownK143125 Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014
Showing 5 of 127 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 127 · See all- K093047Smith & Nephew Circular Fixation SystemSmith & Nephew, Inc. · 2010 · cites it directly51descendants
- K070555Orthopro Steinman Pins and Kirschner WiresOrthopro, LLC · 2007 · cites it directly37descendants
- K141078Orthofix TL-Hex True Lok Hexalobe System (TL-Hex)Orthofix Srl · 2014 · 2 generations on32descendants
- K113006I-Fuse Hammer Toe SystemsOrthopro, LLC · 2012 · 2 generations on27descendants
- K143125Orthofix True Lok Hexapod System VI.3Orthofix Srl · 2014 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… | Smith & Nephew, Inc. | 2000 | — |
| +1 | K093047 | Smith & Nephew Circular Fixation System | Smith & Nephew, Inc. | 2010 | 1 |
| +1 | K070555 | Orthopro Steinman Pins and Kirschner Wires | Orthopro, LLC | 2007 | — |
| +2 | K141078 | Orthofix TL-Hex True Lok Hexalobe System (TL-Hex) | Orthofix Srl | 2014 | — |
| +2 | K113006 | I-Fuse Hammer Toe Systems | Orthopro, LLC | 2012 | — |
| +3 | K143125 | Orthofix True Lok Hexapod System VI.3 | Orthofix Srl | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 4 | 0 |
| 2012 | 5 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 5 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 7 | 0 |
| 2021 | 13 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 14 | 0 |
| 2026 | 10 | 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? (6)
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 |
|---|---|---|---|
| * | — | Hex-Fix® Field Fixator — Smith & Nephew Named without a submission number | |
| * | — | Richards Colles Fracture Frame — Smith & Nephew Named without a submission number | |
| * | — | Simple Small External Fixator — Synthes Named without a submission number | |
| * | — | Compass® Universal Hinge — Smith & Nephew Named without a submission number | |
| * | — | Richards External Fixation System — Smith & Nephew Named without a submission number | |
| * | — | Taylor Spatial Frame External Fixation System - Smith & Nephew Named without a submission number |
What descends from it? (127)
See all 12719 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K093047 | Smith & Nephew Circular Fixation System | 2010 | 51 |
| K070555 | Orthopro Steinman Pins and Kirschner Wires | 2007 | 37 |
| K031181 | External Fixation Systems | 2003 | 24 |
| K091258 | Extrafix External Fixation System | 2009 | 11 |
| K090926 | Smith & Nephew Rail System | 2009 | 10 |
| K113383 | Xtrafix External Fixation System | 2012 | 8 |
| K042436 | Iiizarov Pulley System | 2004 | 8 |
| K130479 | Ilizarov Drill Tip Wires | 2013 | 6 |
| K120871 | Smith & Nephew, Inc. External Fixation System Instrumentation | 2012 | 6 |
| K102215 | Kirschner Wires, Steinman Pins | 2010 | 6 |
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-1762-2012 | 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-1761-2012 | 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-1747-2012 | 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-1752-2012 | 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-1757-2012 | 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-1760-2012 | 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-1748-2012 | 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-1754-2012 | 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-1759-2012 | 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-1753-2012 | 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-1763-2012 | 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-1756-2012 | 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-1750-2012 | 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-1755-2012 | 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-1758-2012 | 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-1751-2012 | 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-1765-2012 | 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-1749-2012 | Packaging | Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility. |
| Jan 23, 2009 | Not classified | Z-2027-2009 | Nonconforming Material/Component | Hinge failure: The product is cracking or breaking during use. |
The 5 latest of 19 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K093047 (Smith & Nephew, Inc., 2010) has gone furthest, with 51 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?
Post-traumatic joint contracture which has resulted in loss of range of motion.
Fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction.
Open and closed fracture fixation.
Pseudoarthrosis of long bones.
Limb lengthening by epiphyseal or metaphyseal distraction.
Correction of bony or soft tissue deformities.
Correction of segmental bony or soft tissue defects.
Joint arthrodesis.
Infected fractures or nonunions.
Management of comminuted intra-articular fractures of the distal radius.
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/K994143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994143: Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories].” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994143
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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