510(k) · Cleared

Cleared

Ebi Small External Fixator (S/E/F/)

K951357510(k) TraditionalCleared Jun 21, 199589-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 Jun 21, 1995 after an 89-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: Jun 21, 1995
Review: 89 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 0

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

This deviceK951357 Ebi Small External Fixator (S/E/F/)Electro-Biology, Inc. · 1995
Descendant · cites it directly · 11 of its ownK052005 R&R External Fixation SystemR&R Medical, Inc. · 2005
Descendant · 2 generations on · 6 of its ownK100137 Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc · 2010
Descendant · 2 generations on · 4 of its ownK153635 SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016
Descendant · 2 generations on · 3 of its ownK162033 SALVATION External Fixation SystemWright Medical · 2017
Descendant · cites it directly · 3 of its ownK993649 Ebi Xfix DFS Wristfix SystemEbi, L.P. · 1999

Showing 5 of 21 descendants. See all descendants

Descendants cleared per year

1999high 3 (2002) · low 0 (2000)2026

Most influential descendants

Showing 5 of 21 · See all

K052005R&R External Fixation SystemR&R Medical, Inc. · 2005 · cites it directly11descendants
K100137Sidekick Circular Fixator System: Struts and HingesWrightmedicaltechnologyinc · 2010 · 2 generations on6descendants
K153635SALVATION (R) External Fixation SystemWrightmedicaltechnologyinc · 2016 · 2 generations on4descendants
K162033SALVATION External Fixation SystemWright Medical · 2017 · 2 generations on3descendants
K993649Ebi Xfix DFS Wristfix SystemEbi, L.P. · 1999 · cites it directly3descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K951357	Ebi Small External Fixator (S/E/F/)	Electro-Biology, Inc.	1995	—
+1	K052005	R&R External Fixation System	R&R Medical, Inc.	2005	—
+2	K100137	Sidekick Circular Fixator System: Struts and Hinges	Wrightmedicaltechnologyinc	2010	—
+2	K153635	SALVATION (R) External Fixation System	Wrightmedicaltechnologyinc	2016	—
+2	K162033	SALVATION External Fixation System	Wright Medical	2017	—
+1	K993649	Ebi Xfix DFS Wristfix System	Ebi, L.P.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	3	0
2005	2	0
2008	1	0
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2014	1	0
2015	1	0
2016	2	0
2017	1	0
2018	2	0
2020	1	0
2025	1	0

FIG. 1 — Lineage of K951357, 1995–2025Source: 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 21.3 · 14 generations · no Class I recall
#2 Held for the reportin the report
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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? (21)

See all 21

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

Number	Device	Applicant	Decided	Descendants
K052005	R&R External Fixation System	R&R Medical, Inc.	2005	11
K993649	Ebi Xfix DFS Wristfix System	Ebi, L.P.	1999	3
K081244	Lower Extremity External Fixation - Expanded Indications	Biomet Trauma	2008	2
K012645	Reprocessed Ebi External Fixation Devices	Alliance Medical Corp.	2002	1
K140158	S.E.a.L. Fracture Fusion Tube	Dne, LLC	2014	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, K052005 (R&R Medical, Inc., 2005) has gone furthest, with 11 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/K951357 · printed Nov 6, 2026

Cite this page

510(k) Report. “K951357: Ebi Small External Fixator (S/E/F/).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951357

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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