510(k) Report

510(k) · Cleared

Cleared

Synthes Straight Wrist Fusion Plate, 170MM

K011458510(k) AbbreviatedCleared Aug 2, 200183-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) · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component

Cleared on Aug 2, 2001 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Aug 2, 2001
Review
83 days
Class
Class II
Product code
KTW
Recalls
None
Predicates
0

11 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2012: 1 descendant cleared2010: 1 descendant cleared2019: 1 descendant cleared2023: 2 descendants cleared2024: 2 descendants cleared2025: 1 descendant cleared2026: 2 descendants cleared200020052010201520202025
  1. This deviceK011458 Synthes Straight Wrist Fusion Plate, 170MMSynthes (Usa) · 2001
  2. Descendant · cites it directly · 8 of its ownK112169 Aptus Wrist Arthrodesis PlatesMedartis AG · 2012
  3. Descendant · 2 generations on · 7 of its ownK192297 APTUS Wrist Arthrodesis PlatesMedartis AG · 2019
  4. Descendant · 3 generations on · 5 of its ownK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023
  5. Descendant · 4 generations on · 3 of its ownK234062 APTUS Hand Scaphoid PlatesMedartis AG · 2024
  6. Descendant · 3 generations on · 3 of its ownK232144 Sterile Products of the APTUS SystemMedartis AG · 2023

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2010: 12012: 12013: 12019: 12023: 22024: 22025: 12026: 2
2010high 2 (2023) · low 0 (2011)2026

Most influential descendants

Showing 5 of 11 · See all
  • K112169Aptus Wrist Arthrodesis PlatesMedartis AG · 2012 · cites it directly8descendants
  • K192297APTUS Wrist Arthrodesis PlatesMedartis AG · 2019 · 2 generations on7descendants
  • K223853Medartis APTUS® Ulna PlatesMedartis AG · 2023 · 3 generations on5descendants
  • K234062APTUS Hand Scaphoid PlatesMedartis AG · 2024 · 4 generations on3descendants
  • K232144Sterile Products of the APTUS SystemMedartis AG · 2023 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011458Synthes Straight Wrist Fusion Plate, 170MMSynthes (Usa)2001—
+1K112169Aptus Wrist Arthrodesis PlatesMedartis AG2012—
+2K192297APTUS Wrist Arthrodesis PlatesMedartis AG2019—
+3K223853Medartis APTUS® Ulna PlatesMedartis AG2023—
+4K234062APTUS Hand Scaphoid PlatesMedartis AG2024—
+3K232144Sterile Products of the APTUS SystemMedartis AG2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201210
201310
201910
202320
202420
202510
202620
FIG. 1 — Lineage of K011458, 2001–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

NumberDeviceApplicantDecidedDescendants
K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128
K100123Acumed Wrist Arthrodesis Plate SystemAcumed, LLC20101
K131380Acumed Totalw Rist Fusion Plating SystemAcumed, LLC20130

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, K112169 (Medartis AG, 2012) has gone furthest, with 8 descendants of its own.

How does its category compare?

All KTW devices

KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTW

1in 2019

2008: 22012: 12016: 12017: 22019: 1
2007high 2 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTW

Too few KTW 510(k)s in any year since 2007 to give a median.

Recalls per year · KTW

57in 2010

2010: 57
2007high 57 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KTW

96in 2025

2007: 32008: 102009: 22010: 262011: 212012: 702013: 702014: 622015: 262016: 412017: 272018: 242019: 112020: 602021: 252022: 502023: 302024: 1232025: 96
2007high 123 (2024) · low 2 (2009)2025

MAUDE reports naming product code KTW, 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
20070—03
20082—010
20090—02
20100—5726
20110—021
20121—070
20130—070
20140—062
20150—026
20161—041
20172—027
20180—024
20191—011
20200—060
20210—025
20220—050
20230—030
20240—0123
20250—096
20260—0—

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 KTW

The KTW category page

  • K182285PK High Tibial Osteotomy Correction SystemPaonan Biotech Co., Ltd. · 2019
  • K171606AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. (Aos) · 2017
  • K170693Phantom Small Bone Intramedullary Nail SystemParagon 28, Inc. · 2017
  • K160409AOS Anterolateral Proximal Humeral PlateAdvanced Orthopaedic Solutions, Inc. · 2016
  • K122541Orthofix Contours Proimal Humeral Plate (PHP)Orthofix Srl · 2012

https://510kreport.com/device/K011458 · printed Nov 6, 2026

Cite this page

510(k) Report. “K011458: Synthes Straight Wrist Fusion Plate, 170MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011458

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026