510(k) Report

510(k) · Cleared

Cleared

Austin Miller Large External Fixation System

K181528510(k) TraditionalCleared Feb 28, 2019262-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

Austin Miller Trauma, LLC · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Feb 28, 2019 as substantially equivalent to K082650 (Synthes (Usa), 2008) and 3 other predicates after a 262-day review. Its family tree reaches back 4 generations to 2000. 2 later devices descend from it.

Decided
Feb 28, 2019
Review
262 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K994143 (2000). 9 ancestors in all. 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2008: 2 other ancestors2003: 1 other ancestor2006: 1 other ancestor2022: 2 descendants clearedK994143 · Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories] · Smith & Nephew, Inc. · 2000 · recalledK091258 · Extrafix External Fixation System · Qfx Technologies, Inc. · 2009K111155 · Xtrafix External Fixation System · Extraortho, Inc. · 2011K113383 · Xtrafix External Fixation System · Extraortho, Inc. · 2012200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 1 other ancestor3 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant K113383 · Xtrafix External Fixation System · Extraortho, Inc. · 2012K111155 · Xtrafix External Fixation System · Extraortho, Inc. · 2011K091258 · Extrafix External Fixation System · Qfx Technologies, Inc. · 2009K994143 · Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories] · Smith & Nephew, Inc. · 2000 · recalled0
  1. Root · 4 generations backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
  2. 3 generations backK091258 Extrafix External Fixation SystemQfx Technologies, Inc. · 2009
  3. 2 generations backK111155 Xtrafix External Fixation SystemExtraortho, Inc. · 2011
  4. 1 generation backK113383 Xtrafix External Fixation SystemExtraortho, Inc. · 2012
  5. This deviceK181528 Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC · 2019
  6. Descendant · cites it directly · 1 of its ownK213874 MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022
  7. Descendant · 2 generations on · 0 of its ownK223112 MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022

Most influential descendants

Showing 2 of 2 · See all
  • K213874MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022 · cites it directly1descendant
  • K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K994143Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral…Smith & Nephew, Inc.200019
−3K091258Extrafix External Fixation SystemQfx Technologies, Inc.2009—
−2K111155Xtrafix External Fixation SystemExtraortho, Inc.2011—
−1K113383Xtrafix External Fixation SystemExtraortho, Inc.2012—
0 (this device)K181528Austin Miller Large External Fixation SystemAustin Miller Trauma, LLC2019—
+1K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.2022—
+2K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310
200610
200820
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202220
FIG. 1 — Lineage of K181528, 2000–2022Source: 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
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What was it cleared against? (4)

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
*K082650Synthes Large External Fixation, MR Conditional
Summary page 4
…bone fixation fastener (21 CFR 888.3040) Regulatory Class: Class II Product Codes: KTT and JDW/Orthopedic/87 III. PREDICATE DEVICES x K082650, Synthes Large External Fixation, MR Conditional x K090658, Synthes Medium External Fixation, MR Conditional x…
Synthes (Usa)20085
*K090658Synthes External Fixation Devices, MR Conditional
Summary page 4
…Class II Product Codes: KTT and JDW/Orthopedic/87 III. PREDICATE DEVICES x K082650, Synthes Large External Fixation, MR Conditional x K090658, Synthes Medium External Fixation, MR Conditional x K113383, XtraFix External Fixation System x K072212, Smith…
Synthes (Usa)20101
*K113383Xtrafix External Fixation System
Summary page 4
…PREDICATE DEVICES x K082650, Synthes Large External Fixation, MR Conditional x K090658, Synthes Medium External Fixation, MR Conditional x K113383, XtraFix External Fixation System x K072212, Smith & Nephew Jet-X Bar System Clamps, Bars and Posts – MR Cond. IV.…
Extraortho, Inc.2012—
*K072212Jet-X Bar System Clamps, Bars and Posts-MR Safe
Summary page 4
…ge External Fixation, MR Conditional x K090658, Synthes Medium External Fixation, MR Conditional x K113383, XtraFix External Fixation System x K072212, Smith & Nephew Jet-X Bar System Clamps, Bars and Posts – MR Cond. IV. DEVICE DESCRIPTION The Austin Miller External Fixat…
Smith & Nephew, Inc.2008—

Also cleared against K082650: 8 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.20221

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?

  • The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
  • 4 of the 9 ancestors have a recall of any class.
  • Of its descendants, K213874 (Smith & Nephew, Inc., 2022) has gone furthest, with 1 descendant of its own.
  • 8 other devices also cite its predicate K082650.

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. 2019, 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 Austin Miller External Fixation System is intended to be used on adult or pediatric patients for stabilization of the long bones, feet, and pelvis. The most common indication is for stabilization of long bone or pelvic fractures, especially when the fractures are combined with soft tissue trauma. Additional indications include non-unions, periarticular fractures, infected fractures or non-unions, joint-bridging immobilization in severe soft-tissue and ligament injuries, arthrodeses, and osteotomies. It can be used in conjunction with internal fixation and can be used intraoperatively as a reduction tool.

Indications for use as stated in the FDA summary.

Also cleared against K082650

8 other devices cite the same predicate.

  • K170146Galaxy UNYCO SystemOrthofix Srl · 2017
  • K153233Galaxy UNYCO SystemOrthofix Srl · 20161 recall
  • K142052Orthofix Galaxy Unyco Diaphyseal Tibia KitOrthofix Srl · 20141 recall
  • K140675Emerge External Fixation SystemEmerge Medical, Inc. · 2014
  • K131413Xtrafix Small External Fixation SystemZimmer, Inc. · 2014
  • K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes · 20132 recalls

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/K181528 · printed Nov 6, 2026

Cite this page

510(k) Report. “K181528: Austin Miller Large External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181528

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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