510(k) · Cleared

Recalled · Class II · 2019

Lower Extremity External Fixation - Expanded Indications

K081244510(k) TraditionalCleared Jul 30, 200890-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

Biomet Trauma · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jul 30, 2008 as substantially equivalent to K040935 (Ebi, L.P., 2004) and 33 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1999. 2 later devices descend from it. It has been recalled once.

Decided: Jul 30, 2008
Review: 90 days
Class: Class II
Product code: KTT
Recalls: 1
Predicates: 34

Its longest line of descent runs back 5 generations to K993886 (1999). 34 ancestors in all, the oldest K951357 (1995). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 5 generations backK993886 Ebi Xfix Vision Fixation SystemEbi, L.P. · 1999
4 generations backK011711 Modification to Ebi Efix Vision Fixation SystemEbi, L.P. · 2001
3 generations backK014194 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2002
2 generations backK033635 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2003
1 generation backK040833 Modification to Ebi Xfix Vision Fixation SystemEbi, L.P. · 2004
This deviceK081244 Lower Extremity External Fixation - Expanded IndicationsBiomet Trauma · 2008
Descendant · cites it directly · 0 of its ownK122210 Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013
Descendant · cites it directly · 0 of its ownK102843 Mac Male AdapterBiomet Trauma (Aka Ebi, LLC) · 2011

Most influential descendants

Showing 2 of 2 · See all

K122210Newfix External Fixation SystemTecnologia Y Diseno Industrial, S.A DE C.V · 2013 · cites it directly0descendants
K102843Mac Male AdapterBiomet Trauma (Aka Ebi, LLC) · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K993886	Ebi Xfix Vision Fixation System	Ebi, L.P.	1999	—
−4	K011711	Modification to Ebi Efix Vision Fixation System	Ebi, L.P.	2001	—
−3	K014194	Modification to Ebi Xfix Vision Fixation System	Ebi, L.P.	2002	—
−2	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	—
0 (this device)	K081244	Lower Extremity External Fixation - Expanded Indications	Biomet Trauma	2008	—
+1	K122210	Newfix External Fixation System	Tecnologia Y Diseno Industrial, S.A DE C.V	2013	—
+1	K102843	Mac Male Adapter	Biomet Trauma (Aka Ebi, LLC)	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	2	0
1996	1	0
1997	1	0
1999	1	0
2000	3	0
2001	5	0
2002	8	0
2003	5	0
2004	1	0
2005	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	0

FIG. 1 — Lineage of K081244, 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? (34)

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
*	K040935	Ebi Xfix DFS System Summary page 1 …iances and accessories (888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290,…	Ebi, L.P.	2004	—
*	K031919	Ebi Xfix DFS System Summary page 1 …d accessories (888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K9…	Ebi, L.P.	2003	—
*	K024129	Modification to Ebi Xfix DFS System Summary page 1 …ries (888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K9…	Ebi, L.P.	2003	—
*	K023399	Ebi Xfix DFS System Summary page 1 …(888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K9…	Ebi, L.P.	2002	—
*	K023324	Modification to Ebi Xfix DFS System Summary page 1 …(888.3030) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357…	Ebi, L.P.	2002	—
*	K022319	Ebi Xfix DFS System Summary page 1 …Legally Marketed Devices To Which Substantial Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® R…	Ebi, L.P.	2002	—
*	K021091	Ebi Xfix DFS System Summary page 1 …Marketed Devices To Which Substantial Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail Syste…	Ebi, L.P.	2002	—
*	K014276	Modification to Ebi Xfix DFS System Summary page 1 …Devices To Which Substantial Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet…	Ebi, L.P.	2002	—
*	K013540	Ebi Xfix Access Pelvic Fixator Summary page 1 …To Which Substantial Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)…	Ebi, L.P.	2001	—
*	K013378	Ebi Xfix DFS System Summary page 1 …Substantial Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031…	Ebi, L.P.	2001	—
*	K012024	Ebi Xfix DFS System Summary page 1 …al Equivalence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437…	Ebi, L.P.	2001	—
*	K011697	Ebi Xfix Access Pelvic Fixator Summary page 1 …lence Is Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083…	Ebi, L.P.	2001	—
*	K000319	Ebi Xfix DFS System Summary page 1 …Claimed: • XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941…	Ebi, L.P.	2000	—
*	K970290	Ebi X Fix Dynafix Mini External Fixation System Summary page 1 …• XFIXO DFSO System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 *…	Ebi, L.P.	1997	—
*	K961433	Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws Summary page 1 …O System (Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Bi…	Electro-Biology, Inc.	1996	—
*	K953406	Ebi X Fix Dynafix System (DFS) Summary page 1 …(Biomet Trauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Tra…	Electro-Biology, Inc.	1995	—
*	K951357	Ebi Small External Fixator (S/E/F/) Summary page 1 …rauma)- K040935, K031919, K024129, K023399, K023324, K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K04…	Electro-Biology, Inc.	1995	—
*	K021031	Ebi Xfix Rail System Summary page 1 …K022319, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 *…	Ebi, L.P.	2002	—
*	K010437	Modification to Ebi Xfix DFS Rail System Summary page 1 …19, K021091, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 * XFIXO Op…	Ebi, L.P.	2001	—
*	K000083	Ebi Xfix DFS Rail System Summary page 1 …91, K014276, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 * XFIXO OptiRom (Bi…	Ebi, L.P.	2000	1
*	K991941	Ebi Xfix DFS Rail System Summary page 1 …76, K013540, K013378, K012024, K011697, K000319, K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 * XFIXO OptiRom (Biornet Tra…	Electro-Biology, Inc.	1999	—
*	K040833	Modification to Ebi Xfix Vision Fixation System Summary page 1 …K970290, K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 * XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyse…	Ebi, L.P.	2004	—
*	K033635	Modification to Ebi Xfix Vision Fixation System Summary page 1 …K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 * XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyseal/Metaph…	Ebi, L.P.	2003	—
*	K020141	Modification to Ebi Xfix Vision Fixation System Summary page 1 …K961433, K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 * XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyseal/Metaphyseal Cor…	Ebi, L.P.	2002	—
*	K014194	Modification to Ebi Xfix Vision Fixation System Summary page 1 …K953406, K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 * XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyseal/Metaphyseal Correction S…	Ebi, L.P.	2002	—
*	K011711	Modification to Ebi Efix Vision Fixation System Summary page 1 …K951357 * XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 * XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyseal/Metaphyseal Correction Systems (B…	Ebi, L.P.	2001	—
*	K993886	Ebi Xfix Vision Fixation System Summary page 1 …* XFIX® DFS® Rail System (Biomet Traumna)- K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 * XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyseal/Metaphyseal Correction Systems (Biomnet Tr…	Ebi, L.P.	1999	—
*	K031093	Ebi Xfix Optirom Knee Fixator Summary page 1 …K021031, K010437, K000083, K991941 * XFIX®~ Vision (Biomnet Trauma)- K040833, K033635, K020141, K014194, K011711, K993886 * XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyseal/Metaphyseal Correction Systems (Biomnet Trauma)- K030372, K024248, K021695, K001358…	Ebi, L.P.	2003	—
*	K030372	Modification to Ebi Dynafix Diaphyseal Correction System Summary page 1 …020141, K014194, K011711, K993886 * XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyseal/Metaphyseal Correction Systems (Biomnet Trauma)- K030372, K024248, K021695, K001358, K953406 * Hoffman® IIMicro External Fixation System (Howmedica Osteonics, Inc.)- K052…	Ebi, L.P.	2003	—
*	K024248	Modification to Ebi Xfix DFS System Metaphyseal Correction System Summary page 1 …014194, K011711, K993886 * XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyseal/Metaphyseal Correction Systems (Biomnet Trauma)- K030372, K024248, K021695, K001358, K953406 * Hoffman® IIMicro External Fixation System (Howmedica Osteonics, Inc.)- K052037, K050…	Ebi, L.P.	2003	—
*	K021695	Ebi Dynafix Diaphyseal Correction System Summary page 1 …993886 * XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyseal/Metaphyseal Correction Systems (Biomnet Trauma)- K030372, K024248, K021695, K001358, K953406 * Hoffman® IIMicro External Fixation System (Howmedica Osteonics, Inc.)- K052037, K050048 Device Descri…	Ebi, L.P.	2002	—
*	K001358	Ebi Xfix DFS Metaphyseal Correction System Summary page 1 …* XFIXO OptiRom (Biornet Trauma)- K03 1093, K953406 * Dynafix Diaphyseal/Metaphyseal Correction Systems (Biomnet Trauma)- K030372, K024248, K021695, K001358, K953406 * Hoffman® IIMicro External Fixation System (Howmedica Osteonics, Inc.)- K052037, K050048 Device Description: Th…	Ebi, L.P.	2000	—
*	K052037	Modification to Hoffmann II Micro External Fixation System Summary page 1 …Correction Systems (Biomnet Trauma)- K030372, K024248, K021695, K001358, K953406 * Hoffman® IIMicro External Fixation System (Howmedica Osteonics, Inc.)- K052037, K050048 Device Description: The Systems consist of external fixation components and implantable bone screws. The system isutili…	Howmedica Osteonics Corp.	2005	—
*	K050048	Hoffman II Micro External Fixation System Summary page 1 …n Systems (Biomnet Trauma)- K030372, K024248, K021695, K001358, K953406 * Hoffman® IIMicro External Fixation System (Howmedica Osteonics, Inc.)- K052037, K050048 Device Description: The Systems consist of external fixation components and implantable bone screws. The system isutilized in th…	Howmedica Osteonics Corp.	2005	—

Also cleared against K040935: 2 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K122210	Newfix External Fixation System	Tecnologia Y Diseno Industrial, S.A DE C.V	2013	0
K102843	Mac Male Adapter	Biomet Trauma (Aka Ebi, LLC)	2011	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Aug 21, 2019	Class II	Z-0528-2020	Environmental control	Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
1 of the 34 ancestors has a recall of any class.
Of its descendants, K122210 (Tecnologia Y Diseno Industrial, S.A DE C.V, 2013) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K040935.

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. 2008, this device’s year, is highlighted.

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?

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 amendable to treatment by use of the external fixation modality.

For the XFIX® DFS® Rail System the indications are unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, acute or gradual correction and other bone conditions amendable to treatment by use of the external fixation modality.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081244 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081244: Lower Extremity External Fixation - Expanded Indications.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081244

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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