510(k) · Cleared

Cleared

Modification to Ebi Xfix Vision Fixation System

K033635510(k) SpecialCleared Dec 3, 200314-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 3, 2003 as substantially equivalent to K993886 (Ebi, L.P., 1999) and 2 other predicates after a 14-day review. Its family tree reaches back 3 generations to 1999. 4 later devices descend from it.

Decided: Dec 3, 2003
Review: 14 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K993886 (1999). 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK993886 Ebi Xfix Vision Fixation SystemEbi, L.P. · 1999
2 generations backK011711 Modification to Ebi Efix Vision Fixation SystemEbi, L.P. · 2001
1 generation backK014194 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002
This deviceK033635 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2003
Descendant · cites it directly · 3 of its ownK040833 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 · cites it directly · 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 4 of 4 · See all

K040833Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2004 · cites it directly3descendants
K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · cites it directly2descendants
K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013 · cites it directly0descendants
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
−3	K993886	Ebi Xfix Vision Fixation System	Ebi, L.P.	1999	—
−2	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	—
0 (this device)	K033635	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2003	—
+1	K040833	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2004	—
+1	K081244	Lower Extremity External Fixation - Expanded Indications	Biomet Trauma	2008	1
+1	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
2004	1	0
2008	1	0
2011	1	0
2013	1	0

FIG. 1 — Lineage of K033635, 1999–2013Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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 …Appliances and Accessories, 21 CFR 888.3030. 3. Predicate or Legally Marketed Device: · EBI® XFIX® Vision® Fixation System (K993886, KO1 1711, K014194) 4. Description of Device: The System consists of external fixation components and implantable bone sc…	Ebi, L.P.	1999	—
*	K011711	Modification to Ebi Efix Vision Fixation System	Ebi, L.P.	2001	—
*	K014194	Modification to Ebi Xfix Vision Fixation System Summary page 1 …Appliances and Accessories, 21 CFR 888.3030. 3. Predicate or Legally Marketed Device: · EBI® XFIX® Vision® Fixation System (K993886, KO1 1711, K014194) 4. Description of Device: The System consists of external fixation components and implantable bone screws. The EBI®…	Ebi, L.P.	2002	—

Also cleared against K993886: 6 other devices →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K040833	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2004	3
K081244	Lower Extremity External Fixation - Expanded Indications	Biomet Trauma	2008	2
K122210	Newfix External Fixation System	Tecnologia Y Diseno Industrial, S.A DE C.V	2013	0

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 4 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
None of the 3 ancestors has a recall.
Of its descendants, K040833 (Ebi, L.P., 2004) has gone furthest, with 3 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 as stated in the FDA summary.

https://510kreport.com/device/K033635 · printed Nov 4, 2026

Cite this page

510(k) Report. “K033635: Modification to 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/K033635

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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