510(k) · Cleared
ClearedExternal Fixation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gexfix USA, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Nov 10, 2005 after a 50-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Nov 10, 2005
- Review
- 50 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK052605 External FixationGexfix USA, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK160972 Gexfix External FixationGexfix International Corp. · 2016
- Descendant · 2 generations on · 0 of its ownK240049 LINK (TM) External FixatorMetric Medical Devices, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK172438 ARBOR External Fixation SystemGlobus Medical, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK082833 NBX - Non-Bridging External Fixator - ShoulderNutek Orthopaedics, Inc. · 2009
Most influential descendants
Showing 4 of 4 · See all- K160972Gexfix External FixationGexfix International Corp. · 2016 · cites it directly2descendants
- K240049LINK (TM) External FixatorMetric Medical Devices, Inc. · 2024 · 2 generations on0descendants
- K172438ARBOR External Fixation SystemGlobus Medical, Inc. · 2018 · cites it directly0descendants
- K082833NBX - Non-Bridging External Fixator - ShoulderNutek Orthopaedics, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052605 | External Fixation | Gexfix USA, Inc. | 2005 | — |
| +1 | K160972 | Gexfix External Fixation | Gexfix International Corp. | 2016 | — |
| +2 | K240049 | LINK (TM) External Fixator | Metric Medical Devices, Inc. | 2024 | — |
| +1 | K172438 | ARBOR External Fixation System | Globus Medical, Inc. | 2018 | — |
| +1 | K082833 | NBX - Non-Bridging External Fixator - Shoulder | Nutek Orthopaedics, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 21.3 · 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?
The FDA summary names no predicate by number.
What descends from it? (4)
3 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, K160972 (Gexfix International Corp., 2016) 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?
1) BONE FRACTURE FIXATION
2) OSTEOTOMY
3) ARTHODESIS
4) CORRECTION OF DEFORMITY
5. REVISION PROCEDURES WHERE OTHER DEVICES HAVE BEE. UNSUCCESSFUL
6) BONE RECONSTRUCTION PROCEDURES
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052605 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052605: External Fixation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052605
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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