510(k) · Cleared
ClearedMAVERICK Mini External Fixation System
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 Dec 8, 2022 as substantially equivalent to K213874 (Smith & Nephew, Inc., 2022) and 1 other predicate after a 66-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- Dec 8, 2022
- Review
- 66 days
- Class
- Class II
- Product code
- JDW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K994143 (2000). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
- 5 generations backK091258 Extrafix External Fixation SystemQfx Technologies, Inc. · 2009
- 4 generations backK111155 Xtrafix External Fixation SystemExtraortho, Inc. · 2011
- 3 generations backK113383 Xtrafix External Fixation SystemExtraortho, Inc. · 2012
- 2 generations backK181528 Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC · 2019
- 1 generation backK213874 MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022
- This deviceK223112 MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral… | Smith & Nephew, Inc. | 2000 | 19 |
| −5 | K091258 | Extrafix External Fixation System | Qfx Technologies, Inc. | 2009 | — |
| −4 | K111155 | Xtrafix External Fixation System | Extraortho, Inc. | 2011 | — |
| −3 | K113383 | Xtrafix External Fixation System | Extraortho, Inc. | 2012 | — |
| −2 | K181528 | Austin Miller Large External Fixation System | Austin Miller Trauma, LLC | 2019 | — |
| −1 | K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | 2022 | — |
| 0 (this device) | K223112 | MAVERICK Mini External Fixation System | Smith & Nephew, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 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? (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 |
|---|---|---|---|
| * | K213874 | MAVERICK External Fixation SystemSummary page 4…Number Smith & Nephew, MAVERICK External Fixation February 11, K213874 Inc. System (Primary Predicate) 2022 Smith & Nephew, Smith & Nephew External… | 2022 |
| * | K994143 | Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…Summary page 4…2022 Smith & Nephew, Smith & Nephew External February 18, K994143 Inc. Fixation System (Jet-X) 2000 Device Description The subject of this premarket… | 2000 |
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 22 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 11 ancestors have a recall of any class.
How does its category compare?
All JDW devicesJDW Pin, Fixation, Threaded: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Smith & Nephew's MAVERICK and MAVERICK Mini External Fixation System is intended to be used for temporary stabilization of the long bones, feet, pelvis, and wrist.
The indications for the Smith & Nephew MAVERICK Mini External Fixation System are the following:
* Open and closed fracture fixation
* Bony or soft tissue deformities
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223112 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223112: MAVERICK Mini External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223112
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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