510(k) · Cleared
Recalled · Class II · 2015Synthes Large External Fixation, 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 Nov 18, 2008 after a 67-day review. The FDA summary names its predicate without a number. 23 later devices descend from it. It has been recalled 5 times.
- Decided
- Nov 18, 2008
- Review
- 67 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 5
- Predicates
- 0
23 later devices descend from it, 9 citing it directly.
- This deviceK082650 Synthes Large External Fixation, MR ConditionalSynthes (Usa) · 2008
- Descendant · cites it directly · 9 of its ownK111155 Xtrafix External Fixation SystemExtraortho, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK113383 Xtrafix External Fixation SystemExtraortho, Inc. · 2012
- 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
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K111155Xtrafix External Fixation SystemExtraortho, Inc. · 2011 · cites it directly9descendants
- K113383Xtrafix External Fixation SystemExtraortho, Inc. · 2012 · 2 generations on8descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082650 | Synthes Large External Fixation, MR Conditional | Synthes (Usa) | 2008 | — |
| +1 | K111155 | Xtrafix External Fixation System | Extraortho, Inc. | 2011 | — |
| +2 | K113383 | Xtrafix External Fixation System | Extraortho, Inc. | 2012 | — |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 6 | 0 |
| 2015 | 4 | 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 21.4 · 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? (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 External Fixation Devices Named without a submission number |
What descends from it? (23)
See all 239 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111155 | Xtrafix External Fixation System | 2011 | 9 |
| 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 |
| K142052 | Orthofix Galaxy Unyco Diaphyseal Tibia Kit | 2014 | 2 |
| K131413 | Xtrafix Small External Fixation System | 2014 | 2 |
| K153233 | Galaxy UNYCO System | 2016 | 1 |
| K140675 | Emerge External Fixation System | 2014 | 1 |
| K170146 | Galaxy UNYCO System | 2017 | 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… |
| 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. |
| Jan 11, 2013 | Class II | Z-0941-2013 | Nonconforming Material/Component | The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts. |
| Oct 12, 2012 | Class II | Z-1816-2013 | Packaging | It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect… |
| Sep 28, 2012 | Class II | Z-0277-2013 | Labeling mix-ups | The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111155 (Extraortho, Inc., 2011) has gone furthest, with 9 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. 2008, 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 Large External Fixation is intended for use to 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 - Polytrauma/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…
Read the full statement (96 words)
Synthes Large External Fixation is intended for use to 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
- Polytrauma/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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082650 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082650: Synthes Large External Fixation, MR Conditional.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082650
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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