510(k) · Cleared
ClearedEbi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Electro-Biology, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jun 28, 1996 after a 74-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.
- Decided
- Jun 28, 1996
- Review
- 74 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 4 citing it directly.
- This deviceK961433 Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone ScrewsElectro-Biology, Inc. · 1996
- Descendant · cites it directly · 2 of its ownK081244 Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · Recalled
- Descendant · cites it directly · 2 of its ownK012193 Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK122210 Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013
- Descendant · 2 generations on · 0 of its ownK102843 Mac Male AdapterBiomet Trauma (Aka Ebi, LLC) · 2011
- Descendant · cites it directly · 0 of its ownK060288 Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc. · 2006
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · cites it directly2descendants
- K012193Amc Antimicrobial Pin/Wire SleeveSmith & Nephew, Inc. · 2002 · cites it directly2descendants
- K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013 · 2 generations on0descendants
- K102843Mac Male AdapterBiomet Trauma (Aka Ebi, LLC) · 2011 · 2 generations on0descendants
- K060288Retro Silver and Xpresso Silver Chronic Hemodialysis CathetersSpire Biomedical, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961433 | Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws | Electro-Biology, Inc. | 1996 | — |
| +1 | K081244 | Lower Extremity External Fixation - Expanded Indications | Biomet Trauma | 2008 | 1 |
| +1 | K012193 | Amc Antimicrobial Pin/Wire Sleeve | Smith & Nephew, Inc. | 2002 | — |
| +2 | K122210 | Newfix External Fixation System | Tecnologia Y Diseno Industrial, S.A DE C.V | 2013 | — |
| +2 | K102843 | Mac Male Adapter | Biomet Trauma (Aka Ebi, LLC) | 2011 | — |
| +1 | K060288 | Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters | Spire Biomedical, Inc. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 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? (5)
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 |
|---|---|---|---|
| * | — | EBI X FIX™ DynaFix™ System and DFS™ Distal Radius Fixator Bone Screws Named without a submission number | |
| * | — | Vitaphore SilverFoam Wound Dressing Named without a submission number | |
| * | — | Genetic Laboratories E-Z DERM™ Temporary Skin Substitute with Silver Named without a submission number | |
| * | — | Arrow Antimicrobial Multi-Lumen Central Venous Catheter Named without a submission number | |
| * | — | Vitaphore Pin Protection Device Named without a submission number |
What descends from it? (8)
4 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, K081244 (Biomet Trauma, 2008) 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 EBI X FIX DynaFix System is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The EBI DFS™ Distal Radius Fixator is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.
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/K961433 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961433: Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961433
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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