510(k) · Cleared

Cleared

Ebi X Fix Dynafix System (DFS)

K953406510(k) TraditionalCleared Oct 31, 1995103-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

Electro-Biology, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Oct 31, 1995 after a 103-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 21 later devices descend from it.

Decided: Oct 31, 1995
Review: 103 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 0

21 later devices descend from it, 17 citing it directly.

This deviceK953406 Ebi X Fix Dynafix System (DFS)Electro-Biology, Inc. · 1995
Descendant · cites it directly · 6 of its ownK031919 Ebi Xfix DFS SystemEbi, L.P. · 2003
Descendant · cites it directly · 5 of its ownK021695 Ebi Dynafix Diaphyseal Correction SystemEbi, L.P. · 2002
Descendant · cites it directly · 4 of its ownK040935 Ebi Xfix DFS SystemEbi, L.P. · 2004
Descendant · cites it directly · 4 of its ownK023324 Modification to Ebi Xfix DFS SystemEbi, L.P. · 2002
Descendant · cites it directly · 3 of its ownK031093 Ebi Xfix Optirom Knee FixatorEbi, L.P. · 2003

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

2001high 7 (2002) · low 0 (2006)2026

Most influential descendants

Showing 5 of 21 · See all

K031919Ebi Xfix DFS SystemEbi, L.P. · 2003 · cites it directly6descendants
K021695Ebi Dynafix Diaphyseal Correction SystemEbi, L.P. · 2002 · cites it directly5descendants
K040935Ebi Xfix DFS SystemEbi, L.P. · 2004 · cites it directly4descendants
K023324Modification to Ebi Xfix DFS SystemEbi, L.P. · 2002 · cites it directly4descendants
K031093Ebi Xfix Optirom Knee FixatorEbi, L.P. · 2003 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K953406	Ebi X Fix Dynafix System (DFS)	Electro-Biology, Inc.	1995	—
+1	K031919	Ebi Xfix DFS System	Ebi, L.P.	2003	—
+1	K021695	Ebi Dynafix Diaphyseal Correction System	Ebi, L.P.	2002	—
+1	K040935	Ebi Xfix DFS System	Ebi, L.P.	2004	—
+1	K023324	Modification to Ebi Xfix DFS System	Ebi, L.P.	2002	—
+1	K031093	Ebi Xfix Optirom Knee Fixator	Ebi, L.P.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	3	0
2002	7	0
2003	4	0
2004	1	0
2005	1	0
2007	1	0
2008	1	0
2011	2	0
2013	1	0

FIG. 1 — Lineage of K953406, 1995–2013Source: 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.

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?

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

What descends from it? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K031919	Ebi Xfix DFS System	Ebi, L.P.	2003	6
K021695	Ebi Dynafix Diaphyseal Correction System	Ebi, L.P.	2002	5
K040935	Ebi Xfix DFS System	Ebi, L.P.	2004	4
K023324	Modification to Ebi Xfix DFS System	Ebi, L.P.	2002	4
K031093	Ebi Xfix Optirom Knee Fixator	Ebi, L.P.	2003	3
K024129	Modification to Ebi Xfix DFS System	Ebi, L.P.	2003	3
K023399	Ebi Xfix DFS System	Ebi, L.P.	2002	3
K022319	Ebi Xfix DFS System	Ebi, L.P.	2002	3
K021091	Ebi Xfix DFS System	Ebi, L.P.	2002	3
K014276	Modification to Ebi Xfix DFS System	Ebi, L.P.	2002	3

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, K031919 (Ebi, L.P., 2003) has gone furthest, with 6 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/K953406 · printed Nov 4, 2026

Cite this page

510(k) Report. “K953406: Ebi X Fix Dynafix System (DFS).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953406

Report an extraction error

Are you the manufacturer?

Record history

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