510(k) · Cleared
Recalled · Class II · 2015Synthes (Usa) Large External Fixation Clamps-MR Safe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on Aug 8, 2003 after a 94-day review. The FDA summary names its predicate without a number. 19 later devices descend from it. It has been recalled once.
- Decided
- Aug 8, 2003
- Review
- 94 days
- Class
- Class II
- Product code
- LXT
- Recalls
- 1
- Predicates
- 0
19 later devices descend from it, 6 citing it directly.
- This deviceK031428 Synthes (Usa) Large External Fixation Clamps-MR SafeSynthes (Usa) · 2003
- Descendant · cites it directly · 11 of its ownK091258 Extrafix External Fixation SystemQfx Technologies, Inc. · 2009
- Descendant · 2 generations on · 9 of its ownK111155 Xtrafix External Fixation SystemExtraortho, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK113383 Xtrafix External Fixation SystemExtraortho, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK122455 Synthes Small External Fixation System, Synthes Large External…Synthes · 2013 · Recalled
- Descendant · 2 generations on · 2 of its ownK181528 Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC · 2019
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K091258Extrafix External Fixation SystemQfx Technologies, Inc. · 2009 · cites it directly11descendants
- K111155Xtrafix External Fixation SystemExtraortho, Inc. · 2011 · 2 generations on9descendants
- K113383Xtrafix External Fixation SystemExtraortho, Inc. · 2012 · cites it directly8descendants
- K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes · 2013 · cites it directly3descendants
- K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031428 | Synthes (Usa) Large External Fixation Clamps-MR Safe | Synthes (Usa) | 2003 | — |
| +1 | K091258 | Extrafix External Fixation System | Qfx Technologies, Inc. | 2009 | — |
| +2 | K111155 | Xtrafix External Fixation System | Extraortho, Inc. | 2011 | — |
| +1 | K113383 | Xtrafix External Fixation System | Extraortho, Inc. | 2012 | — |
| +1 | K122455 | Synthes Small External Fixation System, Synthes Large External Fixation System | Synthes | 2013 | 2 |
| +2 | K181528 | Austin Miller Large External Fixation System | Austin Miller Trauma, LLC | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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 LXT? 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 LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
What was it cleared against? (3)
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 Universal Clamp (four and six position), and Rod Attachment Named without a submission number | |
| * | — | Synthes Tube-to-Tube Clamp Named without a submission number | |
| * | — | Synthes Adjustable Clamp Named without a submission number |
What descends from it? (19)
See all 196 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091258 | Extrafix External Fixation System | 2009 | 11 |
| K113383 | Xtrafix External Fixation System | 2012 | 8 |
| K122455 | Synthes Small External Fixation System, Synthes Large External Fixation System | 2013 | 3 |
| K172438 | ARBOR External Fixation System | 2018 | 0 |
| K171211 | OIC External Fixation System | 2017 | 0 |
| K051957 | Reprocessed External Fixation Device | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 29, 2015 | Class II | Z-2451-2015 | Labeling design | Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K091258 (Qfx Technologies, Inc., 2009) has gone furthest, with 11 descendants of its own.
How does its category compare?
All LXT devicesLXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LXT
Too few LXT 510(k)s in any year since 2007 to give a median.
Recalls per year · LXT
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXT
7in 2025
MAUDE reports naming product code LXT, 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 | 1 | — | 1 | 26 |
| 2008 | 1 | — | 0 | 58 |
| 2009 | 1 | — | 7 | 41 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 1 | — | 0 | 85 |
| 2012 | 0 | — | 0 | 42 |
| 2013 | 2 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 35 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 66 |
| 2018 | 0 | — | 2 | 73 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Synthes Large External Fixation Clamps - MR Safe are indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the Synthes MR Safe Large External Fixation Clamps and their accessories are intended for: Stabilization of open or closed fractures with soft tissue injuries; Polytrauma; Vertically stable pelvic fractures or as a treatment adjunct for vertically…
Read the full statement (108 words)
Synthes Large External Fixation Clamps - MR Safe are indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the Synthes MR Safe Large External Fixation Clamps and their accessories are intended for:
Stabilization of open or closed fractures with soft tissue injuries;
Polytrauma;
Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures;
Arthrodesis and osteotomies with soft tissue problems;
Failures of totai joints;
Neutralization of fractures stabilized with limited internal fixation;
Non-uniondseptic non-unions;
Intraoperative reductiodstabilization tool to assist with indirect reduction;
Unilateral rectilinear bone segment transport or leg lengthening
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031428: Synthes (Usa) Large External Fixation Clamps-MR Safe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031428
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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