510(k) · Cleared
Recalled · Class II · 2014Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications
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 May 11, 2010 after a 294-day review. The FDA summary names its predicate without a number. 14 later devices descend from it. It has been recalled once.
- Decided
- May 11, 2010
- Review
- 294 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 0
14 later devices descend from it, 3 citing it directly.
- This deviceK092190 Synthes Distraction Osteogenesis System, MR Conditional with…Synthes (Usa) · 2010
- Descendant · cites it directly · 8 of its ownK161417 DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC · 2016
- Descendant · 2 generations on · 4 of its ownK191241 AutoStrutOrthospin · 2019
- Descendant · 3 generations on · 3 of its ownK202810 AutoStrut G2Orthospin, Ltd. · 2021
- Descendant · cites it directly · 3 of its ownK113695 Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 2 of its ownK211313 MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K161417DePuy Synthes MAXFRAME Multi-Axial Correction SystemSynthes USA, LLC · 2016 · cites it directly8descendants
- K191241AutoStrutOrthospin · 2019 · 2 generations on4descendants
- K202810AutoStrut G2Orthospin, Ltd. · 2021 · 3 generations on3descendants
- K113695Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc. · 2012 · cites it directly3descendants
- K211313MAXFRAME Multi-Axial Correction System (aka MAXFRAME)Synthes (USA) Products, LLC · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092190 | Synthes Distraction Osteogenesis System, MR Conditional with Expanded… | Synthes (Usa) | 2010 | — |
| +1 | K161417 | DePuy Synthes MAXFRAME Multi-Axial Correction System | Synthes USA, LLC | 2016 | — |
| +2 | K191241 | AutoStrut | Orthospin | 2019 | — |
| +3 | K202810 | AutoStrut G2 | Orthospin, Ltd. | 2021 | — |
| +1 | K113695 | Ellipse Precice Trauma Nail System | Ellipse Technologies, Inc. | 2012 | 2 |
| +2 | K211313 | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) | Synthes (USA) Products, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (2)
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 Distraction Osteogenesis System Named without a submission number | |
| * | — | Synthies Large External Fixation, MR Conditional Named without a submission number |
What descends from it? (14)
See all 143 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)
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, K161417 (Synthes USA, LLC, 2016) has gone furthest, with 8 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?
The Synthes Distraction Osteogenesis System, MR Conditional is intended for fracture fixation (open and closed), pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092190 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092190: Synthes Distraction Osteogenesis System, MR Conditional with Expanded Indications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092190
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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