510(k) · Cleared
ClearedEbi Xfix Access Pelvic Fixator
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 Jun 27, 2001 after a 26-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jun 27, 2001
- Review
- 26 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK011697 Ebi Xfix Access Pelvic FixatorEbi, L.P. · 2001
- 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
- Descendant · cites it directly · 0 of its ownK070016 Blue SharkMeridan Medical · 2007
Most influential descendants
Showing 4 of 4 · 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
- K070016Blue SharkMeridan Medical · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011697 | Ebi Xfix Access Pelvic Fixator | Ebi, L.P. | 2001 | — |
| +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 | — |
| +1 | K070016 | Blue Shark | Meridan Medical | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 21.3 · 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? (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 |
|---|---|---|---|
| * | — | EBI® XFIX® DFS® System Named without a submission number |
What descends from it? (4)
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, 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® XFIX® Access™ Pelvic Fixator and EBI® XFIX® DFS® System are unilateral external fixation devices 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011697 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011697: Ebi Xfix Access Pelvic Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011697
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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