510(k) Report

510(k) · Cleared

Cleared

Synthes (Usa) Wrist Fusion Plates (WFP)

K000558510(k) TraditionalCleared Apr 14, 200056-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) · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Cleared on Apr 14, 2000 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it.

Decided
Apr 14, 2000
Review
56 days
Class
Class II
Product code
LXT
Recalls
None
Predicates
0

27 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2013: 1 descendant cleared2012: 2 descendants cleared2010: 1 descendant cleared2005: 1 descendant cleared2009: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2019: 2 descendants cleared2014: 1 descendant cleared2025: 3 descendants cleared2024: 5 descendants cleared2026: 6 descendants cleared2023: 2 descendants cleared200020052010201520202025
  1. This deviceK000558 Synthes (Usa) Wrist Fusion Plates (WFP)Synthes (Usa) · 2000
  2. Descendant · cites it directly · 11 of its ownK113733 Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
  3. Descendant · 2 generations on · 8 of its ownK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
  4. Descendant · cites it directly · 8 of its ownK112169 Aptus Wrist Arthrodesis PlatesMedartis AG · 2012
  5. Descendant · 2 generations on · 7 of its ownK192297 APTUS Wrist Arthrodesis PlatesMedartis AG · 2019
  6. Descendant · 3 generations on · 5 of its ownK223853 Medartis APTUS® Ulna PlatesMedartis AG · 2023

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2005: 12009: 12010: 12012: 22013: 12014: 12015: 12017: 12019: 22023: 22024: 52025: 32026: 6
2005high 6 (2026) · low 0 (2006)2026

Most influential descendants

Showing 5 of 27 · See all
  • K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012 · cites it directly11descendants
  • K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014 · 2 generations on8descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000558Synthes (Usa) Wrist Fusion Plates (WFP)Synthes (Usa)2000—
+1K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A2012—
+2K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A2014—
+1K112169Aptus Wrist Arthrodesis PlatesMedartis AG2012—
+2K192297APTUS Wrist Arthrodesis PlatesMedartis AG2019—
+3K223853Medartis APTUS® Ulna PlatesMedartis AG2023—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200910
201010
201220
201310
201410
201510
201710
201920
202320
202450
202530
202660
FIG. 1 — Lineage of K000558, 2000–2026Source: 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 LXT? 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 LXT device

  1. #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
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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? (27)

See all 27

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

NumberDeviceApplicantDecidedDescendants
K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A201211
K112169Aptus Wrist Arthrodesis PlatesMedartis AG20128
K052754Wrist Fusion PlateDvo Extremity Solutions, LLC20052
K100123Acumed Wrist Arthrodesis Plate SystemAcumed, LLC20101
K160553DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.20170
K151178VariAx 2 Wrist Fusion SystemStryker Trauma AG20150
K131380Acumed Totalw Rist Fusion Plating SystemAcumed, LLC20130
K093163Integra Total Wrist Fusion SystemIntegra LifeSciences Corporation20090

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, K113733 (Neoortho Produtos Ortopedicos S/A, 2012) has gone furthest, with 11 descendants of its own.

How does its category compare?

All LXT devices

LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXT

1in 2023

2007: 12008: 12009: 12011: 12013: 22023: 1
2007high 2 (2013) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXT

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

Recalls per year · LXT

2in 2018

2007: 12009: 72018: 2
2007high 7 (2009) · low 0 (2008)2026

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

Adverse event reports per year · LXT

7in 2025

2007: 262008: 582009: 412010: 332011: 852012: 422013: 392014: 362015: 352016: 382017: 662018: 732019: 402020: 322021: 242022: 212023: 182024: 272025: 7
2007high 85 (2011) · low 7 (2025)2025

MAUDE reports naming product code LXT, 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
20071—126
20081—058
20091—741
20100—033
20111—085
20120—042
20132—039
20140—036
20150—035
20160—038
20170—066
20180—273
20190—040
20200—032
20210—024
20220—021
20231—018
20240—027
20250—07
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 LXT

The LXT category page

  • K230067Para-Fix External Fixation SystemNew Paradigm Biomedical · 2023
  • K131636Polarus ConnectAcumed, LLC · 2013
  • K132704Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowBiomet · 20131 recall
  • K112345Distal Volar Radius Plating SystemsMedos International SARL · 20114 recalls
  • K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM Threaded and Smooth…DePuy Orthopaedics, Inc. · 2009

https://510kreport.com/device/K000558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000558: Synthes (Usa) Wrist Fusion Plates (WFP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000558

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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