510(k) · Cleared

Cleared

Modification to Ebi Efix Vision Fixation System

K011711510(k) SpecialCleared Jun 29, 200125-day reviewClass II21 CFR 888.3030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ebi, L.P. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jun 29, 2001 as substantially equivalent to K993886 (Ebi, L.P., 1999) after a 25-day review. Its family tree reaches back 1 generation to 1999. 13 later devices descend from it.

Decided: Jun 29, 2001
Review: 25 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K993886 (1999). 13 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK993886 Ebi Xfix Vision Fixation SystemEbi, L.P. · 1999
This deviceK011711 Modification to Ebi Efix Vision Fixation SystemEbi, L.P. · 2001
Descendant · cites it directly · 11 of its ownK014194 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002
Descendant · cites it directly · 9 of its ownK020141 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002
Descendant · 2 generations on · 8 of its ownK021031 Ebi Xfix Rail SystemEbi, L.P. · 2002
Descendant · cites it directly · 4 of its ownK033635 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2003
Descendant · 3 generations on · 4 of its ownK031875 Inter-OS Limb LengthenerInter-Os Technologies · 2003

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2002high 3 (2002) · low 0 (2006)2026

Most influential descendants

Showing 5 of 13 · See all

K014194Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002 · cites it directly11descendants
K020141Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002 · cites it directly9descendants
K021031Ebi Xfix Rail SystemEbi, L.P. · 2002 · 2 generations on8descendants
K033635Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2003 · cites it directly4descendants
K031875Inter-OS Limb LengthenerInter-Os Technologies · 2003 · 3 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993886	Ebi Xfix Vision Fixation System	Ebi, L.P.	1999	—
0 (this device)	K011711	Modification to Ebi Efix Vision Fixation System	Ebi, L.P.	2001	—
+1	K014194	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2002	—
+1	K020141	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2002	—
+2	K021031	Ebi Xfix Rail System	Ebi, L.P.	2002	—
+1	K033635	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2003	—
+3	K031875	Inter-OS Limb Lengthener	Inter-Os Technologies	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	3	0
2003	2	0
2004	1	0
2005	1	0
2008	1	0
2011	1	0
2013	1	0
2019	1	0
2020	2	0

FIG. 1 — Lineage of K011711, 1999–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K993886	Ebi Xfix Vision Fixation System Summary page 1 …le Multiple Component Metallic Bone Fixation Appliances and Accessories, 21 CFR 888.3030. . Predicate or ngally Marketed Device: e EBI® XFIX® Vision® Fixation System (K993886) 4. Description of Device: The System consmts of external fixation components and implantable bone screws. The EBI® XFI}){m Vis…	Ebi, L.P.	1999	—

Also cleared against K993886: 6 other devices →

What descends from it? (13)

See all 13

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K014194	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2002	11
K020141	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2002	9
K033635	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2003	4
K081244	Lower Extremity External Fixation - Expanded Indications	Biomet Trauma	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?

Its one ancestor has no recall.
Of its descendants, K014194 (Ebi, L.P., 2002) has gone furthest, with 11 descendants of its own.
6 other devices also cite its predicate K993886.

How does its category compare?

All KTT devices

KTT 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

2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007high 14 (2018) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTT

673in 2025

2007high 961 (2021) · low 45 (2007)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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K011711 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011711: Modification to Ebi Efix Vision Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011711

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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