510(k) Report

510(k) · Cleared

Cleared

External Fixation Systems

K031181510(k) TraditionalCleared Jul 14, 200390-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

Smith & Nephew, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Jul 14, 2003 as substantially equivalent to K994143 (Smith & Nephew, Inc., 2000) after a 90-day review. Its family tree reaches back 1 generation to 2000. 24 later devices descend from it.

Decided
Jul 14, 2003
Review
90 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K994143 (2000). 24 later devices descend from it, 9 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2012: 2 descendants cleared2013: 2 descendants cleared2017: 1 descendant cleared2010: 1 descendant cleared2016: 2 descendants cleared2019: 2 descendants cleared2020: 2 descendants cleared2024: 2 descendants cleared2021: 2 descendants cleared2025: 4 descendants cleared2026: 1 descendant cleared2023: 2 descendants clearedK994143 · Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories] · Smith & Nephew, Inc. · 2000 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 9 descendants2 generations forward: 5 descendants3 generations forward: 6 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants K994143 · Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular) Fixators and Accessories] · Smith & Nephew, Inc. · 2000 · recalled0+5
  1. Root · 1 generation backK994143 Smith & Nephew External Fixation System [Unilateral (Linear) &…Smith & Nephew, Inc. · 2000 · Recalled
  2. This deviceK031181 External Fixation SystemsSmith & Nephew, Inc. · 2003
  3. Descendant · cites it directly · 17 of its ownK113327 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012 · Recalled
  4. Descendant · cites it directly · 15 of its ownK130907 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2013
  5. Descendant · cites it directly · 15 of its ownK130334 Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG · 2013
  6. Descendant · cites it directly · 14 of its ownK140961 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014
  7. Descendant · cites it directly · 13 of its ownK153377 Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · Recalled

Showing 5 of 24 descendants. See all descendants

Descendants cleared per year

2010: 12012: 22013: 22014: 12016: 22017: 12019: 22020: 22021: 22023: 22024: 22025: 42026: 1
2010high 4 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 24 · See all
  • K113327Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp. · 2012 · cites it directly17descendants
  • K130907Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2013 · cites it directly15descendants
  • K130334Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG · 2013 · cites it directly15descendants
  • K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG · 2014 · cites it directly14descendants
  • K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH · 2016 · cites it directly13descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K994143Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral…Smith & Nephew, Inc.200019
0 (this device)K031181External Fixation SystemsSmith & Nephew, Inc.2003—
+1K113327Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp.20123
+1K130907Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG2013—
+1K130334Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG2013—
+1K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG2014—
+1K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH20162

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201220
201320
201410
201620
201710
201920
202020
202120
202320
202420
202540
202610
FIG. 1 — Lineage of K031181, 2000–2026Source: 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? (1)

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
*K994143Smith & Nephew External Fixation System [Unilateral (Linear) & Multilateral (Circular)…
Summary page 1
…l Equivalence Information: The intended use of the reprocessed external fixation bar clamps and pin clamps is identical to that of the Smith & Nephew Unilateral Fixator (K994143) and the Smith & Nephew Unilateral Wrist Fixator for Distal Radius Fractures (K994143). The design and the function of the subjec…
Smith & Nephew, Inc.200019

Also cleared against K994143: 18 other devices →

What descends from it? (24)

See all 24

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

NumberDeviceApplicantDecidedDescendants
K113327Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Corp.201217
K130907Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG201315
K130334Hoffmann LRF (Limb Reconstruction Frame System)Stryker Trauma AG201315
K140961Hoffmann LRF (Limb Reconstruction Frame) SystemStryker Trauma AG201414
K153377Hoffmann LRF (Limb Reconstruction Frame) SystemStryker GmbH201613
K163656Hoffmann LRF SystemStryker GmbH201711
K120871Smith & Nephew, Inc. External Fixation System InstrumentationSmith & Nephew, Inc.20126
K181630Revolution External Plating SystemNew Standard Device Dba Metalogix20191
K100795Jet-X Bar System Clamps and Posts ReprocessingSmith & Nephew, Inc.20100

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?

  • Its one ancestor has a recall.
  • Of its descendants, K113327 (Stryker Corp., 2012) has gone furthest, with 17 descendants of its own.
  • 18 other devices also cite its predicate K994143.

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

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?

External Fixation System components are intended to be used on adults or pediatric patients as required and are intended to be used for fracture fixation (open and closed); post-traumatic joint contracture which has resulted in loss of range of motion; fractures and disease which generally may result in joint contractures or loss of range of motion and fractures requiring distraction; pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; joint arthrodesis; and management of comminuted intra-articular fractures of the distal radius.

Indications for use as stated in the FDA summary.

Also cleared against K994143

18 other devices cite the same predicate.

  • K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc. · 2022
  • K221792Acute QC Strut and ComponentsSmith & Nephew, Inc. · 2022
  • K213874MAVERICK External Fixation SystemSmith & Nephew, Inc. · 2022
  • K210953SMART Taylor Spatial FrameSmith & Nephew, Inc. · 2021
  • K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other…Smith & Nephew · 2020
  • K130479Ilizarov Drill Tip WiresSmith & Nephew, Inc. · 2013

More from Smith & Nephew, Inc.

692 FDA decisions under this applicant name. See the company

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981)…Smith & Nephew, Inc. · 2026
  • DEN250037TESSA Spatial Surgery System; INTELLIO Tablet (72205455)Smith & Nephew, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026

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/K031181 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031181: External Fixation Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031181

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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