510(k) · Cleared
ClearedReprocessed External Fixation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliance Medical Corp. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jun 24, 2002 as substantially equivalent to K000682 (Synthes (Usa), 2000) and 1 other predicate after a 315-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jun 24, 2002
- Review
- 315 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000682 (2000). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000682 Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000
- This deviceK012623 Reprocessed External Fixation DeviceAlliance Medical Corp. · 2002
- Descendant · cites it directly · 0 of its ownK032058 Modification to Reprocessed Synthes External Fixation DevicesAlliance Medical Corp. · 2003
Most influential descendants
Showing 1 of 1 · See all- K032058Modification to Reprocessed Synthes External Fixation DevicesAlliance Medical Corp. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | — |
| 0 (this device) | K012623 | Reprocessed External Fixation Device | Alliance Medical Corp. | 2002 | — |
| +1 | K032058 | Modification to Reprocessed Synthes External Fixation Devices | Alliance Medical Corp. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 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? (7)
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 |
|---|---|---|---|
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) System | 2000 |
| * | K010344 | Adjustable Large Fixator System | 2001 |
| * | — | Synthes TraumaFixTM External Fixator Named without a submission number | |
| * | — | Synthes (U.S.A.) Mini External Fixator Named without a submission number | |
| * | — | Synthes Titanium External Fixator Clamps Named without a submission number | |
| * | — | Synthes Combination Clamp and Dynamization Clip Named without a submission number | |
| * | — | Synthes Simple Small External Fixator Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032058 | Modification to Reprocessed Synthes External Fixation Devices | 2003 | 0 |
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?
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?
Reprocessed external fixation devices are indicated for use in
patients requiring external skeletal fixation and treatment of fractures, osteotomy,
arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures,
limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft
tissue defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K012623 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012623: Reprocessed External Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012623
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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