510(k) · Cleared
ClearedSynthes Medium External Fixation System-MR Safe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Mar 23, 2004 after a 48-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Mar 23, 2004
- Review
- 48 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 4 citing it directly.
- This deviceK040258 Synthes Medium External Fixation System-MR SafeSynthes (Usa) · 2004
- Descendant · cites it directly · 1 of its ownK071628 Stryker External Fixation SystemStryker Cmf · 2007
- Descendant · cites it directly · 0 of its ownK172438 ARBOR External Fixation SystemGlobus Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK122208 External Fixator SystemChristopher D. Endara · 2012
- Descendant · 2 generations on · 0 of its ownK072764 KLS Martin Xternal FixatorKLS Martin L.P. · 2007
- Descendant · cites it directly · 0 of its ownK051957 Reprocessed External Fixation DeviceSterilemed, Inc. · 2005 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K071628Stryker External Fixation SystemStryker Cmf · 2007 · cites it directly1descendant
- K172438ARBOR External Fixation SystemGlobus Medical, Inc. · 2018 · cites it directly0descendants
- K122208External Fixator SystemChristopher D. Endara · 2012 · cites it directly0descendants
- K072764KLS Martin Xternal FixatorKLS Martin L.P. · 2007 · 2 generations on0descendants
- K051957Reprocessed External Fixation DeviceSterilemed, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K040258 | Synthes Medium External Fixation System-MR Safe | Synthes (Usa) | 2004 | — |
| +1 | K071628 | Stryker External Fixation System | Stryker Cmf | 2007 | — |
| +1 | K172438 | ARBOR External Fixation System | Globus Medical, Inc. | 2018 | — |
| +1 | K122208 | External Fixator System | Christopher D. Endara | 2012 | — |
| +2 | K072764 | KLS Martin Xternal Fixator | KLS Martin L.P. | 2007 | — |
| +1 | K051957 | Reprocessed External Fixation Device | Sterilemed, Inc. | 2005 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2012 | 1 | 0 |
| 2018 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 Medium External Fixation System Named without a submission number |
What descends from it? (5)
4 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, K071628 (Stryker Cmf, 2007) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The Synthes (USA) Medium External Fixation System is intended for use in the construction of an external fixator frame for the treatment of pediatric and adult fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040258 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040258: Synthes Medium External Fixation System-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/K040258
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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