510(k) · Cleared
ClearedAdjustable Large Fixator System
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 3, 2001 after an 87-day review. Our reading found no predicate number; beside “510(k)” the summary prints a number our reading could not make out (“KO0344”). 5 later devices descend from it.
- Decided
- May 3, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK010344 Adjustable Large Fixator SystemSynthes (Usa) · 2001
- Descendant · cites it directly · 2 of its ownK110965 Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011
- Descendant · cites it directly · 1 of its ownK012623 Reprocessed External Fixation DeviceAlliance Medical Corp. · 2002
- Descendant · 2 generations on · 0 of its ownK213905 ONX Large External Fixation SystemOrthonovis, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK171211 OIC External Fixation SystemOrthopaedic Implant Company · 2017
- Descendant · 2 generations on · 0 of its ownK032058 Modification to Reprocessed Synthes External Fixation DevicesAlliance Medical Corp. · 2003
Most influential descendants
Showing 5 of 5 · See all- K110965Renovis T 710 Large External Fixation SystemRenovis Surgical Technologies, LLC · 2011 · cites it directly2descendants
- K012623Reprocessed External Fixation DeviceAlliance Medical Corp. · 2002 · cites it directly1descendant
- K213905ONX Large External Fixation SystemOrthonovis, Inc. · 2022 · 2 generations on0descendants
- K171211OIC External Fixation SystemOrthopaedic Implant Company · 2017 · 2 generations on0descendants
- K032058Modification to Reprocessed Synthes External Fixation DevicesAlliance Medical Corp. · 2003 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010344 | Adjustable Large Fixator System | Synthes (Usa) | 2001 | — |
| +1 | K110965 | Renovis T 710 Large External Fixation System | Renovis Surgical Technologies, LLC | 2011 | — |
| +1 | K012623 | Reprocessed External Fixation Device | Alliance Medical Corp. | 2002 | — |
| +2 | K213905 | ONX Large External Fixation System | Orthonovis, Inc. | 2022 | — |
| +2 | K171211 | OIC External Fixation System | Orthopaedic Implant Company | 2017 | — |
| +2 | K032058 | Modification to Reprocessed Synthes External Fixation Devices | Alliance Medical Corp. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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 Large External Fixator Named without a submission number |
What descends from it? (5)
2 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, K110965 (Renovis Surgical Technologies, LLC, 2011) has gone furthest, with 2 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?
The Synthes (USA) Adjustable Large Fixator System is intended for use in the treatment of conditions of the long bones including fractures, osteotomies, and other bone conditions amenable to treatment with a unilateral external fixator.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K010344 · printed Nov 4, 2026
Cite this page
510(k) Report. “K010344: Adjustable Large Fixator System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010344
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026