510(k) Report

510(k) · Cleared

Cleared

Angled Blade Plate

K914546510(k) TraditionalCleared Nov 29, 199149-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 Nov 29, 1991 after a 49-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided
Nov 29, 1991
Review
49 days
Class
Class II
Product code
KTW
Recalls
None
Predicates
0

10 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2017: 2 descendants cleared2008: 1 descendant cleared2023: 3 descendants cleared2011: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2020: 1 descendant cleared1990200020102020
  1. This deviceK914546 Angled Blade PlateSynthes (Usa) · 1991
  2. Descendant · cites it directly · 4 of its ownK112085 Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC · 2011
  3. Descendant · cites it directly · 1 of its ownK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
  4. Descendant · 2 generations on · 1 of its ownK200246 JPS JuniOrtho Plating SystemOrthofix Srl · 2020
  5. Descendant · cites it directly · 1 of its ownK080109 Synthes (Usa) Modular Blade Plate SystemSynthes (Usa) · 2008 · Recalled
  6. Descendant · cites it directly · 0 of its ownK221787 Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2008: 12011: 12017: 22020: 12021: 12022: 12023: 3
2008high 3 (2023) · low 0 (2009)2026

Most influential descendants

Showing 5 of 10 · See all
  • K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC · 2011 · cites it directly4descendants
  • K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021 · cites it directly1descendant
  • K200246JPS JuniOrtho Plating SystemOrthofix Srl · 2020 · 2 generations on1descendant
  • K080109Synthes (Usa) Modular Blade Plate SystemSynthes (Usa) · 2008 · cites it directly1descendant
  • K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited · 2023 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K914546Angled Blade PlateSynthes (Usa)1991—
+1K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC2011—
+1K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma2021—
+2K200246JPS JuniOrtho Plating SystemOrthofix Srl2020—
+1K080109Synthes (Usa) Modular Blade Plate SystemSynthes (Usa)200856
+1K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201110
201720
202010
202110
202210
202330
FIG. 1 — Lineage of K914546, 1991–2023Source: 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), 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
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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? (10)

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

NumberDeviceApplicantDecidedDescendants
K112085Synthes LCP Pediatric Plate SystemsSynthes (USA) Products, LLC20114
K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma20211
K080109Synthes (Usa) Modular Blade Plate SystemSynthes (Usa)20081
K221787Auxein's DHS/DCS Plate SystemAuxein Medical Private Limited20230
K170704The Locking Pediatric Osteotomy Plate (LolliPOP) SystemPega Medical, Inc.20170
K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170

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, K112085 (Synthes (USA) Products, LLC, 2011) has gone furthest, with 4 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/K914546 · printed Nov 5, 2026

Cite this page

510(k) Report. “K914546: Angled Blade Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K914546

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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