510(k) · Cleared
ClearedSynthes (Usa) Synthes Hybrid External Fixator
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 May 22, 1995 after a 110-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 5 later devices descend from it.
- Decided
- May 22, 1995
- Review
- 110 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK950384 Synthes (Usa) Synthes Hybrid External FixatorSynthes (Usa) · 1995
- Descendant · cites it directly · 3 of its ownK122455 Synthes Small External Fixation System, Synthes Large External…Synthes · 2013 · Recalled
- Descendant · 2 generations on · 1 of its ownK141912 Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone…Advanced Orthopaedic Solutions, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK232897 Arthrex Small External Fixation SystemArthrex, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK171911 Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK073135 Synthes (Usa) Hybrid External Fixator ModificationsSynthes (Usa) · 2008
Most influential descendants
Showing 5 of 5 · See all- K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes · 2013 · cites it directly3descendants
- K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc. · 2014 · 2 generations on1descendant
- K232897Arthrex Small External Fixation SystemArthrex, Inc. · 2023 · 3 generations on0descendants
- K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc. · 2017 · 2 generations on0descendants
- K073135Synthes (Usa) Hybrid External Fixator ModificationsSynthes (Usa) · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950384 | Synthes (Usa) Synthes Hybrid External Fixator | Synthes (Usa) | 1995 | — |
| +1 | K122455 | Synthes Small External Fixation System, Synthes Large External Fixation System | Synthes | 2013 | 2 |
| +2 | K141912 | Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External… | Advanced Orthopaedic Solutions, Inc. | 2014 | — |
| +3 | K232897 | Arthrex Small External Fixation System | Arthrex, Inc. | 2023 | — |
| +2 | K171911 | Medline ReNewal Reprocessed Synthes External Fixation Systems | Surgical Instrument Service and Savings, Inc. | 2017 | — |
| +1 | K073135 | Synthes (Usa) Hybrid External Fixator Modifications | Synthes (Usa) | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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 6.4 · 2 generations · no Class I recall
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K122455 (Synthes, 2013) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K950384 · printed Nov 5, 2026
Cite this page
510(k) Report. “K950384: Synthes (Usa) Synthes Hybrid External Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K950384
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026