510(k) · Cleared

Cleared

Ebi Xfix Vision Fixation System

K993886510(k) SpecialCleared Dec 14, 199928-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 Dec 14, 1999 after a 28-day review. The FDA summary names its predicate without a number. 14 later devices descend from it.

Decided: Dec 14, 1999
Review: 28 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 0

14 later devices descend from it, 7 citing it directly.

This deviceK993886 Ebi Xfix Vision Fixation SystemEbi, L.P. · 1999
Descendant · cites it directly · 13 of its ownK011711 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 · cites it directly · 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

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2001high 3 (2002) · low 0 (2006)2026

Most influential descendants

Showing 5 of 14 · See all

K011711Modification to Ebi Efix Vision Fixation SystemEbi, L.P. · 2001 · cites it directly13descendants
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 · cites it directly8descendants
K033635Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2003 · cites it directly4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K993886	Ebi Xfix Vision Fixation System	Ebi, L.P.	1999	—
+1	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	—
+1	K021031	Ebi Xfix Rail System	Ebi, L.P.	2002	—
+1	K033635	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
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 K993886, 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 21.4 · 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? (2)

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
*	—	EBI XFIX® DFS® System Named without a submission number			—
*	—	Hoffmann II External Fixation System Named without a submission number			—

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K011711	Modification to Ebi Efix Vision Fixation System	Ebi, L.P.	2001	13
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
K021031	Ebi Xfix Rail System	Ebi, L.P.	2002	8
K033635	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2003	4
K040833	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2004	3
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?

Of its descendants, K011711 (Ebi, L.P., 2001) has gone furthest, with 13 descendants of its own.

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/K993886 · printed Nov 4, 2026

Cite this page

510(k) Report. “K993886: Ebi Xfix Vision Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993886

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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