510(k) Report

510(k) · Cleared

Cleared

Synthes Small Cobination Clamp-MR Safe

K031724510(k) TraditionalCleared Jul 14, 200341-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

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

Cleared on Jul 14, 2003 after a 41-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.

Decided
Jul 14, 2003
Review
41 days
Class
Class II
Product code
KTT
Recalls
None
Predicates
0

7 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 3 descendants cleared2013: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK031724 Synthes Small Cobination Clamp-MR SafeSynthes (Usa) · 2003
  2. Descendant · cites it directly · 3 of its ownK122455 Synthes Small External Fixation System, Synthes Large External…Synthes · 2013 · Recalled
  3. Descendant · cites it directly · 2 of its ownK131413 Xtrafix Small External Fixation SystemZimmer, Inc. · 2014
  4. Descendant · 2 generations on · 1 of its ownK141912 Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone…Advanced Orthopaedic Solutions, Inc. · 2014
  5. Descendant · 2 generations on · 1 of its ownK141697 Xtrafix External Fixation System, Xtrafix Small External Fixation…Zimmer, Inc. · 2014
  6. Descendant · 3 generations on · 0 of its ownK232897 Arthrex Small External Fixation SystemArthrex, Inc. · 2023

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2013: 12014: 32015: 12017: 12023: 1
2013high 3 (2014) · low 0 (2016)2026

Most influential descendants

Showing 5 of 7 · See all
  • K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes · 2013 · cites it directly3descendants
  • K131413Xtrafix Small External Fixation SystemZimmer, Inc. · 2014 · cites it directly2descendants
  • K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation…Advanced Orthopaedic Solutions, Inc. · 2014 · 2 generations on1descendant
  • K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc. · 2014 · 2 generations on1descendant
  • K232897Arthrex Small External Fixation SystemArthrex, Inc. · 2023 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031724Synthes Small Cobination Clamp-MR SafeSynthes (Usa)2003—
+1K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes20132
+1K131413Xtrafix Small External Fixation SystemZimmer, Inc.2014—
+2K141912Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External…Advanced Orthopaedic Solutions, Inc.2014—
+2K141697Xtrafix External Fixation System, Xtrafix Small External Fixation SystemZimmer, Inc.2014—
+3K232897Arthrex Small External Fixation SystemArthrex, Inc.2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201430
201510
201710
202310
FIG. 1 — Lineage of K031724, 2003–2023Source: 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
*—Imedica’s TransFx Small External Fixation System
Named without a submission number
—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K122455Synthes Small External Fixation System, Synthes Large External Fixation SystemSynthes20133
K131413Xtrafix Small External Fixation SystemZimmer, Inc.20142

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?

  • Of its descendants, K122455 (Synthes, 2013) has gone furthest, with 3 descendants of its own.

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?

Synthes Small Combination Clamps - MR Safe are intended for fractures of the distal radius, open and/or comminuted or bilateral fractures; fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; fractures and dislocations of hand, wrist, mandible and foot; failed closed reduction and casting resulting in secondary deformity of the distal radius.

Indications for use as stated in the FDA summary.

More from Synthes (Usa)

406 FDA decisions under this applicant name. See the company

  • K131984Synthes Synsonic Ulna NailSynthes (Usa) · 2014
  • K111667Synthes Suprapatellar Insertion InstrumentsSynthes (Usa) · 20111 recall
  • K111540Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
  • K110789Synthes Sternal Zipfix SystemSynthes (Usa) · 20113 recalls
  • K103002Synthes Multiloc Proximal Humeral Nailing SystemSynthes (Usa) · 20112 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/K031724 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031724: Synthes Small Cobination Clamp-MR Safe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031724

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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