510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Construx External Fixation Device

K111376510(k) TraditionalCleared Aug 3, 201179-day reviewClass II21 CFR 888.3030Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ebi, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Aug 3, 2011 as substantially equivalent to K953406 (Electro-Biology, Inc., 1995) and 4 other predicates after a 79-day review. Its family tree reaches back 3 generations to 1995. It has been recalled once.

Decided
Aug 3, 2011
Review
79 days
Class
Class II
Product code
KTT
Recalls
1
Predicates
5

Its longest line of descent runs back 3 generations to K953406 (1995). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestors2000: 1 other ancestorK953406 · Ebi X Fix Dynafix System (DFS) · Electro-Biology, Inc. · 1995K031919 · Ebi Xfix DFS System · Ebi, L.P. · 2003K040935 · Ebi Xfix DFS System · Ebi, L.P. · 20041995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor K040935 · Ebi Xfix DFS System · Ebi, L.P. · 2004K031919 · Ebi Xfix DFS System · Ebi, L.P. · 2003K953406 · Ebi X Fix Dynafix System (DFS) · Electro-Biology, Inc. · 19950
  1. Root · 3 generations backK953406 Ebi X Fix Dynafix System (DFS)Electro-Biology, Inc. · 1995
  2. 2 generations backK031919 Ebi Xfix DFS SystemEbi, L.P. · 2003
  3. 1 generation backK040935 Ebi Xfix DFS SystemEbi, L.P. · 2004
  4. This deviceK111376 Construx External Fixation DeviceEbi, LLC · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K953406Ebi X Fix Dynafix System (DFS)Electro-Biology, Inc.1995—
−2K031919Ebi Xfix DFS SystemEbi, L.P.2003—
−1K040935Ebi Xfix DFS SystemEbi, L.P.2004—
0 (this device)K111376Construx External Fixation DeviceEbi, LLC2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200220
FIG. 1 — Lineage of K111376, 1995–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K953406Ebi X Fix Dynafix System (DFS)
Summary page 2
…rux External Fixation System is the same as, or similar to, the predicate devices. Examples of predicate devices include: * Construx External Fixation System (K953406/K021I695/K023324) * DFS Aluminum Ankle Assembly (K953406) " DFS Carbon Ankle Assembly (K03 1…
Electro-Biology, Inc.1995—
*K021695Ebi Dynafix Diaphyseal Correction SystemEbi, L.P.2002—
*K023324Modification to Ebi Xfix DFS System
Summary page 2
…tion System is the same as, or similar to, the predicate devices. Examples of predicate devices include: * Construx External Fixation System (K953406/K021I695/K023324) * DFS Aluminum Ankle Assembly (K953406) " DFS Carbon Ankle Assembly (K03 1919) * DFS Ca…
Ebi, L.P.2002—
*K031919Ebi Xfix DFS System
Summary page 2
…trux External Fixation System (K953406/K021I695/K023324) * DFS Aluminum Ankle Assembly (K953406) " DFS Carbon Ankle Assembly (K03 1919) * DFS Carbon Fixator Straight Clamp (K040935) * DFS Left and Right Telescoping Arms (K953406) * DES Angular H…
Ebi, L.P.2003—
*K040935Ebi Xfix DFS System
Summary page 2
…3324) * DFS Aluminum Ankle Assembly (K953406) " DFS Carbon Ankle Assembly (K03 1919) * DFS Carbon Fixator Straight Clamp (K040935) * DFS Left and Right Telescoping Arms (K953406) * DES Angular Hinge Clamp (K953406) " DES Ring to F…
Ebi, L.P.2004—

Also cleared against K953406: 16 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
May 1, 2015Class IIZ-1741-2015Process controlAnkle clamp was assembled incorrectly; the offset of the pin to the pivot point is reversed. This prevents complete range of motion and if pushed too far may loosen the pin from the bone. A revision surgery may be necessary to adequately…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
  • None of the 6 ancestors has a recall.
  • 16 other devices also cite its predicate K953406.

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. 2011, this device’s year, is highlighted.

FDA decisions per year · KTT

10in 2025

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
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

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—

What is it indicated for?

The Construx External Fixation System is a unilateral external fixation device intended for

use in children and adults in the treatment of bone conditions including leg lengthening,

osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment

by the use of the external fixation modality.

Indications for use as stated in the FDA summary.

Also cleared against K953406

16 other devices cite the same predicate.

  • K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013
  • K081244Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 20081 recall
  • K040935Ebi Xfix DFS SystemEbi, L.P. · 2004
  • K031919Ebi Xfix DFS SystemEbi, L.P. · 2003
  • K031093Ebi Xfix Optirom Knee FixatorEbi, L.P. · 2003
  • K024129Modification to Ebi Xfix DFS SystemEbi, L.P. · 2003

More from Ebi, LLC

4 FDA decisions under this applicant name. See the company

  • K140734Nextgen Altius Oct SystemEbi, LLC · 2014
  • K140123Polaris Spinal System -Translation ScrewEbi, LLC · 20141 recall
  • K113796Solitaire-C Cervical Spacer SystemEbi, LLC · 20121 recall

Recent decisions in KTT

The KTT category page

  • K263083Response Ortho Smart Fixator - Hexapod SystemResponse Ortho Solutions, LLC · 2026
  • K254087MAXFRAME AUTOSTRUT™ with Bluetooth Multi-Axial Correction SystemSynthes (USA) Products, LLC · 2026
  • K260900DYNEX® External Fixation SystemsVilex, LLC · 2026
  • K260112QuikFix External Fixator: Knee-Spanning PackStabiliz Orthopaedics, Inc. · 2026
  • K253291Excelsior SystemBlue Ocean Global · 2026

https://510kreport.com/device/K111376 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111376: Construx External Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111376

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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