510(k) · Cleared
ClearedSynthes (Usa) External Fixation Component Line Extension - 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 Jan 18, 2005 after a 75-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jan 18, 2005
- Review
- 75 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK043039 Synthes (Usa) External Fixation Component Line Extension - MR SafeSynthes (Usa) · 2005
- 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
Most influential descendants
Showing 4 of 4 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043039 | Synthes (Usa) External Fixation Component Line Extension - MR Safe | Synthes (Usa) | 2005 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 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 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 21.4 · 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? (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 Reprocessed External Fixation Devices Named without a submission number | |
| * | — | Hoffmann II External Fixation System (Stryker) Named without a submission number | |
| * | — | FBI XFLX Vision Fixation System Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122455 | Synthes Small External Fixation System, Synthes Large External Fixation System | 2013 | 3 |
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 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?
Synthes External Fixation Devices - MR Safe are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation. LARGE Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: * Stabilization of soft tissues and fractures * Poyltrauma/multiple orthopedic trauma * Vertically stable pelvic fractures, or as a…
Read the full statement (134 words)
Synthes External Fixation Devices - MR Safe are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation.
LARGE
Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:
* Stabilization of soft tissues and fractures
* Poyltrauma/multiple orthopedic trauma
* Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures
* Arthrodeses and osteotomies with soft tissue problems; failures of total joints
· Neutralization of fractures stabilized with limited internal fixation
• Non-unions/septic non-unions
* Intra-operative reductions/stabilization tool to assist with indirect reduction
· Unilateral rectilinear bone segment transport or leg lengthening
MEDIUM
Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043039 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043039: Synthes (Usa) External Fixation Component Line Extension - MR Safe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043039
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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