510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Synthes Small External Fixation System, Synthes Large External Fixation System

K122455510(k) TraditionalCleared Apr 11, 2013241-day reviewClass II21 CFR 888.3030Recalls 2

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

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

Cleared on Apr 11, 2013 as substantially equivalent to K031724 (Synthes (Usa), 2003) and 13 other predicates after a 241-day review. Its family tree reaches back 1 generation to 1992. 3 later devices descend from it. It has been recalled 2 times.

Decided
Apr 11, 2013
Review
241 days
Class
Class II
Product code
KTT
Recalls
2
Predicates
14

Its longest line of descent runs back 1 generation to K914558 (1992). 14 ancestors in all. 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2010: 1 other ancestor2008: 1 other ancestor2005: 2 other ancestors2004: 1 other ancestor2003: 4 other ancestors1996: 2 other ancestors1995: 2 other ancestors2014: 1 descendant cleared2017: 1 descendant cleared2023: 1 descendant clearedK914558 · Traumafix (TM) External Fixator · Synthes (Usa) · 19921990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 13 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K914558 · Traumafix (TM) External Fixator · Synthes (Usa) · 19920
  1. Root · 1 generation backK914558 Traumafix (TM) External FixatorSynthes (Usa) · 1992
  2. This deviceK122455 Synthes Small External Fixation System, Synthes Large External…Synthes · 2013
  3. Descendant · cites it directly · 1 of its ownK141912 Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone…Advanced Orthopaedic Solutions, Inc. · 2014
  4. Descendant · 2 generations on · 0 of its ownK232897 Arthrex Small External Fixation SystemArthrex, Inc. · 2023
  5. Descendant · cites it directly · 0 of its ownK171911 Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc. · 2017

Most influential descendants

Showing 3 of 3 · See all
  • K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc. · 2014 · cites it directly1descendant
  • K232897Arthrex Small External Fixation SystemArthrex, Inc. · 2023 · 2 generations on0descendants
  • K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K914558Traumafix (TM) External FixatorSynthes (Usa)1992—
0 (this device)K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes2013—
+1K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External…Advanced Orthopaedic Solutions, Inc.2014—
+2K232897Arthrex Small External Fixation SystemArthrex, Inc.2023—
+1K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc.2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
199620
200340
200410
200520
200810
201010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201410
201710
202310
FIG. 1 — Lineage of K122455, 1992–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

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  2. #2 Held for the reportin the report
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Get a 510(k) Report

What was it cleared against? (14)

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
*K031724Synthes Small Cobination Clamp-MR Safe
Summary page 1
…bone fixation appliances and accessories. Product Code: KTT Predicate Device: Synthes Small External Fixation System (K03 1724, K033 158, K96 1350, K(031724,1K05063 1,1K090658,1K082650,1K952296,1K04070 1)…
Synthes (Usa)2003—
*K033158Synthes Reprocessed External Fixation Devices
Summary page 1
…bone fixation appliances and accessories. Product Code: KTT Predicate Device: Synthes Small External Fixation System (K03 1724, K033 158, K96 1350, K(031724,1K05063 1,1K090658,1K082650,1K952296,1K04070 1) Synthes…
Synthes (Usa)20031
*K961350Synthes Mini External Fixator
Summary page 1
…fixation appliances and accessories. Product Code: KTT Predicate Device: Synthes Small External Fixation System (K03 1724, K033 158, K96 1350, K(031724,1K05063 1,1K090658,1K082650,1K952296,1K04070 1) Synthes Large Exte…
Synthes (Usa)1996—
*K050631Synthes (Usa) Small Adjustable Clamp-MR Safe Line Extension
Summary page 1
…Product Code: KTT Predicate Device: Synthes Small External Fixation System (K03 1724, K033 158, K96 1350, K(031724,1K05063 1,1K090658,1K082650,1K952296,1K04070 1) Synthes Large External Fixation System (K082650, K033 158,1K0303…
Synthes (Usa)2005—
*K090658Synthes External Fixation Devices, MR Conditional
Summary page 1
…Product Code: KTT Predicate Device: Synthes Small External Fixation System (K03 1724, K033 158, K96 1350, K(031724,1K05063 1,1K090658,1K082650,1K952296,1K04070 1) Synthes Large External Fixation System (K082650, K033 158,1K030390,…
Synthes (Usa)20101
*K082650Synthes Large External Fixation, MR Conditional
Summary page 1
…Product Code: KTT Predicate Device: Synthes Small External Fixation System (K03 1724, K033 158, K96 1350, K(031724,1K05063 1,1K090658,1K082650,1K952296,1K04070 1) Synthes Large External Fixation System (K082650, K033 158,1K030390,…
Synthes (Usa)20085
*K952296Synthes (Usa) [Synthes[ Self-Drilling Schanz Screw
Summary page 1
…ode: KTT Predicate Device: Synthes Small External Fixation System (K03 1724, K033 158, K96 1350, K(031724,1K05063 1,1K090658,1K082650,1K952296,1K04070 1) Synthes Large External Fixation System (K082650, K033 158,1K030390,…
Synthes (Usa)19951
*K040701Synthes (Usa) Hydroxyapatite (HA) Coated Schanz Screws
Summary page 1
…Predicate Device: Synthes Small External Fixation System (K03 1724, K033 158, K96 1350, K(031724,1K05063 1,1K090658,1K082650,1K952296,1K04070 1) Synthes Large External Fixation System (K082650, K033 158,1K030390, K03 142…
Synthes (Usa)2004—
*K030390Synthes Large Combination Clamp and Dynamization Clip - MR Safe
Summary page 1
…K(031724,1K05063 1,1K090658,1K082650,1K952296,1K04070 1) Synthes Large External Fixation System (K082650, K033 158,1K030390, K03 1428, K9629 13, K952296, K950384, K043039,.K9 14558) Device Description: Synthes Reprocesse…
Synthes (Usa)20032
*K031428Synthes (Usa) Large External Fixation Clamps-MR Safe
Summary page 1
…,1K05063 1,1K090658,1K082650,1K952296,1K04070 1) Synthes Large External Fixation System (K082650, K033 158,1K030390, K03 1428, K9629 13, K952296, K950384, K043039,.K9 14558) Device Description: Synthes Reprocessed External Fixation Devices consist…
Synthes (Usa)20031
*K962913Synthes Sterile Drill Bits
Summary page 1
…,1K090658,1K082650,1K952296,1K04070 1) Synthes Large External Fixation System (K082650, K033 158,1K030390, K03 1428, K9629 13, K952296, K950384, K043039,.K9 14558) Device Description: Synthes Reprocessed External Fixation Devices consist of various…
Synthes (Usa)1996—
*K950384Synthes (Usa) Synthes Hybrid External Fixator
Summary page 1
…1K952296,1K04070 1) Synthes Large External Fixation System (K082650, K033 158,1K030390, K03 1428, K9629 13, K952296, K950384, K043039,.K9 14558) Device Description: Synthes Reprocessed External Fixation Devices consist of various clamps,…
Synthes (Usa)1995—
*K043039Synthes (Usa) External Fixation Component Line Extension - MR Safe
Summary page 1
…1K04070 1) Synthes Large External Fixation System (K082650, K033 158,1K030390, K03 1428, K9629 13, K952296, K950384, K043039,.K9 14558) Device Description: Synthes Reprocessed External Fixation Devices consist of various clamps,…
Synthes (Usa)2005—
*K914558Traumafix (TM) External Fixator
Summary page 1
…) Synthes Large External Fixation System (K082650, K033 158,1K030390, K03 1428, K9629 13, K952296, K950384, K043039,.K9 14558) Device Description: Synthes Reprocessed External Fixation Devices consist of various clamps, ro…
Synthes (Usa)1992—

Also cleared against K031724: 1 other device →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc.20141
K171911Medline ReNewal Reprocessed Synthes External Fixation SystemsSurgical Instrument Service and Savings, Inc.20170

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 29, 2015Class IIZ-2451-2015Labeling designLabeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered…
Apr 10, 2014Class IIZ-1833-2014Labeling Change ControlLabeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 6 of the 14 ancestors have a recall of any class.
  • Of its descendants, K141912 (Advanced Orthopaedic Solutions, Inc., 2014) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K031724.

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. 2013, 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 Synthes Small External Fixation System is intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for: * Preliminary fixation before ORIF * Unstable fractures of the distal radius (both intra- and extra-articular) * Open and/or comminuted bilateral fractures * Fractures in combination with extensive soft tissue injury, bone loss, and…

Read the full statement (195 words)

The Synthes Small External Fixation System is intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle. Specifically, the components can be used for:

* Preliminary fixation before ORIF

* Unstable fractures of the distal radius (both intra- and extra-articular)

* Open and/or comminuted bilateral fractures

* Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement

* Fracture dislocations

* Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations)

* Pediatric open fractures with bone loss and osteotomies

The Synthes Large External Fixation Systems is intended to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for:

* Stabilization of soft tissues and fractures

* Poyltrauma/multiple orthopedic trauma

* Vertically stable pelvic fractures, or as a treatment adjunct for vertically unstable pelvic fractures

* Arthrodeses and osteotomes with soft tissue problems; failures of total joints

* Neutralization of fractures stabilized with limited internal fixation

* Non-unions/septic non-unions

* Intra-operative reductions/stabilization tool to assist with indirect reduction

* Unilateral rectilinear bone segment transport or leg lengthening

Indications for use as stated in the FDA summary.

Also cleared against K031724

1 other device cites the same predicate.

  • K131413Xtrafix Small External Fixation SystemZimmer, Inc. · 2014

More from Synthes

11 FDA decisions under this applicant name. See the company

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  • K113071Synthecel Dura Replacement DevicesSynthes · 20125 recalls
  • K110604VBB SystemSynthes · 20111 recall
  • K093772Synthes Sternal Fixation SystemSynthes · 2010
  • K013072Chronos Tricalcium Prosphate (Chronos TCP)Synthes · 2002

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/K122455 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122455: Synthes Small External Fixation System, Synthes 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/K122455

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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