510(k) · Cleared
ClearedModification to Ebi Xfix Vision Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ebi, L.P. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Apr 29, 2004 as substantially equivalent to K993886 (Ebi, L.P., 1999) and 2 other predicates after a 29-day review. Its family tree reaches back 4 generations to 1999. 3 later devices descend from it.
- Decided
- Apr 29, 2004
- Review
- 29 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K993886 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK993886 Ebi Xfix Vision Fixation SystemEbi, L.P. · 1999
- 3 generations backK011711 Modification to Ebi Efix Vision Fixation SystemEbi, L.P. · 2001
- 2 generations backK014194 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002
- 1 generation backK033635 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2003
- This deviceK040833 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2004
- Descendant · cites it directly · 2 of its ownK081244 Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · Recalled
- 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
Most influential descendants
Showing 3 of 3 · See all- K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K993886 | Ebi Xfix Vision Fixation System | Ebi, L.P. | 1999 | — |
| −3 | K011711 | Modification to Ebi Efix Vision Fixation System | Ebi, L.P. | 2001 | — |
| −2 | K014194 | Modification to Ebi Xfix Vision Fixation System | Ebi, L.P. | 2002 | — |
| −1 | K033635 | Modification to Ebi Xfix Vision Fixation System | Ebi, L.P. | 2003 | — |
| 0 (this device) | K040833 | Modification to Ebi Xfix Vision Fixation System | Ebi, L.P. | 2004 | — |
| +1 | K081244 | Lower Extremity External Fixation - Expanded Indications | Biomet Trauma | 2008 | 1 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993886 | Ebi Xfix Vision Fixation SystemSummary page 2…devices: The modified EBI® XFIX® Vision® Fixation System is substantially equivalent to the following predicate device: EBI® XFIX® Vision® Fixation System (K993886, KO0 1711, K014194, K033635) * The additional EBI® XFIX® Vision® Fixation System components are… | 1999 |
| Kept off the family tree | K001711 | FDA’s K001711 is M2410B Imagepoint HX Multispecialty System, Version B.1 Our reading of the summary gave K001711, FDA’s number for M2410B Imagepoint HX Multispecialty System, Version B.1 (Agilent Technologies, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “EBI® XFIX® Vision® Fixation System”. Kept off the family tree. | 2000 |
| * | K014194 | Modification to Ebi Xfix Vision Fixation SystemSummary page 1…Appliances and Accessories, 21 CFR 888.3030. 3. Predicate or Legally Marketed Device: EBI® XFIX® Vision® Fixation System (K(993886, KO01171 1, K014194, K(033635) 4. Description of Device: The System consists of external fixation components and implantable b… | 2002 |
| * | K033635 | Modification to Ebi Xfix Vision Fixation SystemSummary page 2…EBI® XFIX® Vision® Fixation System is substantially equivalent to the following predicate device: EBI® XFIX® Vision® Fixation System (K993886, KO0 1711, K014194, K033635) * The additional EBI® XFIX® Vision® Fixation System components are fabricated from the same mat… | 2003 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081244 | Lower Extremity External Fixation - Expanded Indications | 2008 | 2 |
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?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K081244 (Biomet Trauma, 2008) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K993886.
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® XFIX® Vision® Fixation System is a unilateral external fixation device intended for use in 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040833 · printed Nov 5, 2026
Cite this page
510(k) Report. “K040833: Modification to Ebi Xfix Vision Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K040833
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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