510(k) · Cleared

Cleared

Extrafix External Fixation System

K091258510(k) TraditionalCleared Jul 24, 200986-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

Qfx Technologies, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jul 24, 2009 as substantially equivalent to K053472 (Howmedica Osteonics Corp., 2006) and 2 other predicates after an 86-day review. Its family tree reaches back 1 generation to 2000. 11 later devices descend from it.

Decided: Jul 24, 2009
Review: 86 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K994143 (2000). 3 ancestors in all. 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
This deviceK091258 Extrafix External Fixation SystemQfx Technologies, Inc. · 2009
Descendant · cites it directly · 9 of its ownK111155 Xtrafix External Fixation SystemExtraortho, Inc. · 2011
Descendant · cites it directly · 8 of its ownK113383 Xtrafix External Fixation SystemExtraortho, Inc. · 2012
Descendant · 2 generations on · 2 of its ownK181528 Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC · 2019
Descendant · 2 generations on · 2 of its ownK131413 Xtrafix Small External Fixation SystemZimmer, Inc. · 2014
Descendant · 3 generations on · 1 of its ownK213874 MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2011high 3 (2015) · low 0 (2013)2026

Most influential descendants

Showing 5 of 11 · See all

K111155Xtrafix External Fixation SystemExtraortho, Inc. · 2011 · cites it directly9descendants
K113383Xtrafix External Fixation SystemExtraortho, Inc. · 2012 · cites it directly8descendants
K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC · 2019 · 2 generations on2descendants
K131413Xtrafix Small External Fixation SystemZimmer, Inc. · 2014 · 2 generations on2descendants
K213874MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K994143	Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral…	Smith & Nephew, Inc.	2000	19
0 (this device)	K091258	Extrafix External Fixation System	Qfx Technologies, Inc.	2009	—
+1	K111155	Xtrafix External Fixation System	Extraortho, Inc.	2011	—
+1	K113383	Xtrafix External Fixation System	Extraortho, Inc.	2012	—
+2	K181528	Austin Miller Large External Fixation System	Austin Miller Trauma, LLC	2019	—
+2	K131413	Xtrafix Small External Fixation System	Zimmer, Inc.	2014	—
+3	K213874	MAVERICK External Fixation System	Smith & Nephew, Inc.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2006	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	1	0
2014	2	0
2015	3	0
2019	1	0
2022	2	0

FIG. 1 — Lineage of K091258, 2000–2022Source: 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? (3)

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
*	K053472	Hoffmann II Mri External Fixation System Summary page 2 …Predicate Devices: The Extrafix External Fixation System is similar to several predicates including the following: · Stryker Hoffmann II MRI External Fixation System (K053472); · Synthes Large External Fixation Clamps- MR S (K031428); and • Smith & Nephew Jet-X Unilateral Fixator (K994143). Technolog…	Howmedica Osteonics Corp.	2006	—
*	K031428	Synthes (Usa) Large External Fixation Clamps-MR Safe Summary page 2 …is similar to several predicates including the following: · Stryker Hoffmann II MRI External Fixation System (K053472); · Synthes Large External Fixation Clamps- MR S (K031428); and • Smith & Nephew Jet-X Unilateral Fixator (K994143). Technological Characteristics The Extrafix External Fixation System…	Synthes (Usa)	2003	1
*	K994143	Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)… Summary page 2 …· Stryker Hoffmann II MRI External Fixation System (K053472); · Synthes Large External Fixation Clamps- MR S (K031428); and • Smith & Nephew Jet-X Unilateral Fixator (K994143). Technological Characteristics The Extrafix External Fixation System was characterized and evaluated according to the requireme…	Smith & Nephew, Inc.	2000	19

Also cleared against K053472: 5 other devices →

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K111155	Xtrafix External Fixation System	Extraortho, Inc.	2011	9
K113383	Xtrafix External Fixation System	Extraortho, Inc.	2012	8
K101338	Newfix External Fixation System	Technologia Y Diseno Industrial, S.A DE C.V	2011	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?

2 of the 3 ancestors have a recall of any class.
Of its descendants, K111155 (Extraortho, Inc., 2011) has gone furthest, with 9 descendants of its own.
5 other devices also cite its predicate K053472.

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. 2009, 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?

The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins. The Extrafix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for: o Temporary stabilization of open or closed…

Read the full statement (166 words)

The Extrafix External Fixation System includes various elements designed to build a fixator construct. The system includes clamps, posts, bars, and fixation pins.

The Extrafix External Fixation System is indicated for use in construction of an external fixation frame for treatment of long bone (foot, femur, and tibia) and pelvic fractures that require external fixation. Specifically, the system is intended for:

o Temporary stabilization of open or closed acute fractures with soft tissue injuries;

o Definitive stabilization of open or closed fractures where open or alternative closed treatment is undesirable or otherwise contraindicated;

o Stabilization of fractures in the context of polytrauma;

o Temporary or definitive stabilization of certain pelvic fractures or pelvic ring injuries;

o Arthrodesis and osteotomies with associated soft tissue problems;

o Stabilization of limbs after removal of total joint (knee and ankle) arthroplasty for infection or other failure;

o Neutralization of fractures stabilized with limited internal fixation;

o Stabilization of non-unions; and

o Intraoperative temporary stabilization tool to assist with indirect reduction.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K091258 · printed Nov 5, 2026

Cite this page

510(k) Report. “K091258: Extrafix External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091258

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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