510(k) Report

510(k) · Cleared

Cleared

Synthes Cannulated Angle Blade Plate

K954289510(k) TraditionalCleared Nov 24, 199571-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 24, 1995 after a 71-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 111 later devices descend from it.

Decided
Nov 24, 1995
Review
71 days
Class
Class II
Product code
KTW
Recalls
None
Predicates
0

111 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2018: 4 descendants cleared2019: 7 descendants cleared2004: 1 descendant cleared2025: 9 descendants cleared2006: 2 descendants cleared2007: 4 descendants cleared2008: 1 descendant cleared2026: 13 descendants cleared2022: 3 descendants cleared2021: 12 descendants cleared2017: 9 descendants cleared2011: 1 descendant cleared2010: 1 descendant cleared2012: 2 descendants cleared2024: 11 descendants cleared2023: 15 descendants cleared2013: 1 descendant cleared2014: 4 descendants cleared2015: 1 descendant cleared2016: 1 descendant cleared2020: 8 descendants cleared1995200020052010201520202025
  1. This deviceK954289 Synthes Cannulated Angle Blade PlateSynthes (Usa) · 1995
  2. Descendant · cites it directly · 110 of its ownK974537 Synthes Cannulated Angle Blade Plate (Cabp) SystemSynthes (Usa) · 1998
  3. Descendant · 2 generations on · 98 of its ownK033639 Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · Recalled
  4. Descendant · 3 generations on · 73 of its ownK073375 Newdeal Tibiaxys SystemNewdeal Sas · 2008 · Recalled
  5. Descendant · 4 generations on · 69 of its ownK110670 VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc…Smith & Nephew, Inc. · 2011
  6. Descendant · 4 generations on · 56 of its ownK100176 Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010

Showing 5 of 111 descendants. See all descendants

Descendants cleared per year

1998: 12004: 12006: 22007: 42008: 12010: 12011: 12012: 22013: 12014: 42015: 12016: 12017: 92018: 42019: 72020: 82021: 122022: 32023: 152024: 112025: 92026: 13
1998high 15 (2023) · low 0 (1999)2026

Most influential descendants

Showing 5 of 111 · See all
  • K974537Synthes Cannulated Angle Blade Plate (Cabp) SystemSynthes (Usa) · 1998 · cites it directly110descendants
  • K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC · 2004 · 2 generations on98descendants
  • K073375Newdeal Tibiaxys SystemNewdeal Sas · 2008 · 3 generations on73descendants
  • K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone Screws…Smith & Nephew, Inc. · 2011 · 4 generations on69descendants
  • K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc. · 2010 · 4 generations on56descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954289Synthes Cannulated Angle Blade PlateSynthes (Usa)1995—
+1K974537Synthes Cannulated Angle Blade Plate (Cabp) SystemSynthes (Usa)1998—
+2K033639Acumed Lower Extremity Congruent Plate SystemAcumed, LLC200410
+3K073375Newdeal Tibiaxys SystemNewdeal Sas20082
+4K110670VLP Foot Talus Plates, VLP Percutaneous Calcaneus Plates and Misc VLP Bone…Smith & Nephew, Inc.2011—
+4K100176Ascension Ankle Fusion Plate SystemAscension Orthopedics, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200410
200620
200740
200810
201010
201110
201220
201310
201440
201510
201610
201790
201840
201970
202080
2021120
202230
2023150
2024110
202590
2026130
FIG. 1 — Lineage of K954289, 1995–2026Source: 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), 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? (111)

See all 111

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K974537Synthes Cannulated Angle Blade Plate (Cabp) SystemSynthes (Usa)1998110

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, K974537 (Synthes (Usa), 1998) has gone furthest, with 110 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/K954289 · printed Nov 6, 2026

Cite this page

510(k) Report. “K954289: Synthes Cannulated Angle Blade Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K954289

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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