510(k) · Cleared
Recalled · Class II · 2014Synthes External Fixation Devices, MR Conditional
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 3, 2010 after a 356-day review. The FDA summary names its predicate without a number. 15 later devices descend from it. It has been recalled once.
- Decided
- Mar 3, 2010
- Review
- 356 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 0
15 later devices descend from it, 5 citing it directly.
- This deviceK090658 Synthes External Fixation Devices, MR ConditionalSynthes (Usa) · 2010
- Descendant · cites it directly · 6 of its ownK113770 Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · Recalled
- Descendant · cites it directly · 3 of its ownK122455 Synthes Small External Fixation System, Synthes Large External…Synthes · 2013 · Recalled
- Descendant · cites it directly · 2 of its ownK181528 Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK142052 Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · Recalled
- Descendant · 2 generations on · 1 of its ownK213874 MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K113770Orthofix Galaxy Fixation SystemOrthofix Srl · 2012 · cites it directly6descendants
- K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes · 2013 · cites it directly3descendants
- K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC · 2019 · cites it directly2descendants
- K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 2014 · 2 generations on2descendants
- K213874MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090658 | Synthes External Fixation Devices, MR Conditional | Synthes (Usa) | 2010 | — |
| +1 | K113770 | Orthofix Galaxy Fixation System | Orthofix Srl | 2012 | 13 |
| +1 | K122455 | Synthes Small External Fixation System, Synthes Large External Fixation System | Synthes | 2013 | 2 |
| +1 | K181528 | Austin Miller Large External Fixation System | Austin Miller Trauma, LLC | 2019 | — |
| +2 | K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia Kit | Orthofix Srl | 2014 | 1 |
| +2 | K213874 | MAVERICK External Fixation System | Smith & Nephew, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (5)
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 Named without a submission number | |
| * | — | Synthes Distal Radius Fixator Named without a submission number | |
| * | — | Synthes Low Profile Wrist Fixator Named without a submission number | |
| * | — | Synthes Elbow Hinge Fixator Named without a submission number | |
| * | — | Synthes Large External Fixation, MR Conditional Named without a submission number |
What descends from it? (15)
See all 155 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113770 | Orthofix Galaxy Fixation System | 2012 | 6 |
| K122455 | Synthes Small External Fixation System, Synthes Large External Fixation System | 2013 | 3 |
| K181528 | Austin Miller Large External Fixation System | 2019 | 2 |
| K171911 | Medline ReNewal Reprocessed Synthes External Fixation Systems | 2017 | 0 |
| K101338 | Newfix External Fixation System | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 10, 2014 | Class II | Z-1833-2014 | Labeling Change Control | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K113770 (Orthofix Srl, 2012) has gone furthest, with 6 descendants 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. 2010, this device’s year, is highlighted.
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?
Synthes External Fixation Devices, MR Conditional are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation. Synthes Medium External Fixation is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures- Synthes Distal Radius Fixator is intended for the fixation of the distal radius. Synthes Low-Profile Wrist Fixator is…
Read the full statement (185 words)
Synthes External Fixation Devices, MR Conditional are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
Synthes Medium External Fixation is intended for the construction of an external fixation frame for the treatment of pediatric and adult fractures-
Synthes Distal Radius Fixator is intended for the fixation of the distal radius.
Synthes Low-Profile Wrist Fixator is intended for stabilization of fractures of the distal radius.
Synthes Elbow Hinge Fixator is intended for supplementary treatment of complex, unstable elbow injuries when early functional stress musi be limited due to persistent ligament instability. The indications for guided joint bridging with external fixators are:
* Delayed treatment of dislocated and stiff elbows
* Chronic, persistent joint instability
* Acute joint instability after complex ligament injuries
* Unstable elbow fractures
* Additional stabilization of post-operative unstable internal fixation
The Elbow Hinge Fixator is compatible with the components of the Synthes Large External Fixator System for adults (rod diameter: 011Imm), and with components of the Synthes Medium External Fixator System (rod diameter: 08mm) for children and.small stature adults.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090658 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090658: Synthes External Fixation Devices, MR Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090658
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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