510(k) · Cleared

Cleared

Modification to Ebi Xfix DFS Rail System

K010437510(k) SpecialCleared Mar 13, 200128-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 Mar 13, 2001 after a 28-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided: Mar 13, 2001
Review: 28 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 0

11 later devices descend from it, 5 citing it directly.

This deviceK010437 Modification to Ebi Xfix DFS Rail SystemEbi, L.P. · 2001
Descendant · cites it directly · 8 of its ownK021031 Ebi Xfix Rail SystemEbi, L.P. · 2002
Descendant · cites it directly · 4 of its ownK031875 Inter-OS Limb LengthenerInter-Os Technologies · 2003
Descendant · 2 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
Descendant · cites it directly · 2 of its ownK081244 Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · Recalled
Descendant · cites it directly · 1 of its ownK012645 Reprocessed Ebi External Fixation DevicesAlliance Medical Corp. · 2002

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2002high 2 (2002) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all

K021031Ebi Xfix Rail SystemEbi, L.P. · 2002 · cites it directly8descendants
K031875Inter-OS Limb LengthenerInter-Os Technologies · 2003 · cites it directly4descendants
K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on2descendants
K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008 · cites it directly2descendants
K012645Reprocessed Ebi External Fixation DevicesAlliance Medical Corp. · 2002 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010437	Modification to Ebi Xfix DFS Rail System	Ebi, L.P.	2001	—
+1	K021031	Ebi Xfix Rail System	Ebi, L.P.	2002	—
+1	K031875	Inter-OS Limb Lengthener	Inter-Os Technologies	2003	—
+2	K192181	PRECICE Plating System	Nuvasive Specialized Orthopedics, Inc.	2019	1
+1	K081244	Lower Extremity External Fixation - Expanded Indications	Biomet Trauma	2008	1
+1	K012645	Reprocessed Ebi External Fixation Devices	Alliance Medical Corp.	2002	—

Descendants by year cleared

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

FIG. 1 — Lineage of K010437, 2001–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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.

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#1 K242861 TrueLok Elevatescore 21.4 · 14 generations · no Class I recall
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K021031	Ebi Xfix Rail System	Ebi, L.P.	2002	8
K031875	Inter-OS Limb Lengthener	Inter-Os Technologies	2003	4
K081244	Lower Extremity External Fixation - Expanded Indications	Biomet Trauma	2008	2
K012645	Reprocessed Ebi External Fixation Devices	Alliance Medical Corp.	2002	1
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?

Of its descendants, K021031 (Ebi, L.P., 2002) has gone furthest, with 8 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	—

https://510kreport.com/device/K010437 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010437: Modification to Ebi Xfix DFS Rail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010437

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026