510(k) · Cleared

Cleared

Wrist Fusion Plate

K052754510(k) TraditionalCleared Oct 27, 200527-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

Dvo Extremity Solutions, LLC · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Cleared on Oct 27, 2005 as substantially equivalent to K000558 (Synthes (Usa), 2000) after a 27-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.

Decided: Oct 27, 2005
Review: 27 days
Class: Class II
Product code: LXT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K000558 (2000). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK000558 Synthes (Usa) Wrist Fusion Plates (WFP)Synthes (Usa) · 2000
This deviceK052754 Wrist Fusion PlateDvo Extremity Solutions, LLC · 2005
Descendant · cites it directly · 1 of its ownK100123 Acumed Wrist Arthrodesis Plate SystemAcumed, LLC · 2010
Descendant · cites it directly · 0 of its ownK131380 Acumed Totalw Rist Fusion Plating SystemAcumed, LLC · 2013

Most influential descendants

Showing 2 of 2 · See all

K100123Acumed Wrist Arthrodesis Plate SystemAcumed, LLC · 2010 · cites it directly1descendant
K131380Acumed Totalw Rist Fusion Plating SystemAcumed, LLC · 2013 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000558	Synthes (Usa) Wrist Fusion Plates (WFP)	Synthes (Usa)	2000	—
0 (this device)	K052754	Wrist Fusion Plate	Dvo Extremity Solutions, LLC	2005	—
+1	K100123	Acumed Wrist Arthrodesis Plate System	Acumed, LLC	2010	—
+1	K131380	Acumed Totalw Rist Fusion Plating System	Acumed, LLC	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2010	1	0
2013	1	0

FIG. 1 — Lineage of K052754, 2000–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 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 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K000558	Synthes (Usa) Wrist Fusion Plates (WFP) Summary page 1 …metallic bone fixation appliances and accessories. DEVICE PRODUCT CODE: 87 LXT PREDICATE DEVICES: Synthes, Wrist Fusion Plates, K000558, cleared 14 April 2000 DEVICE DESCRIPTION: These anatomically contoured plates are offered in two lengths…	Synthes (Usa)	2000	—

Also cleared against K000558: 7 other devices →

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K100123	Acumed Wrist Arthrodesis Plate System	Acumed, LLC	2010	1
K131380	Acumed Totalw Rist Fusion Plating System	Acumed, LLC	2013	0

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?

Its one ancestor has no recall.
Of its descendants, K100123 (Acumed, LLC, 2010) has gone furthest, with 1 descendant of its own.
7 other devices also cite its predicate K000558.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	1	—	1	26
2008	1	—	0	58
2009	1	—	7	41
2010	0	—	0	33
2011	1	—	0	85
2012	0	—	0	42
2013	2	—	0	39
2014	0	—	0	36
2015	0	—	0	35
2016	0	—	0	38
2017	0	—	0	66
2018	0	—	2	73
2019	0	—	0	40
2020	0	—	0	32
2021	0	—	0	24
2022	0	—	0	21
2023	1	—	0	18
2024	0	—	0	27
2025	0	—	0	7
2026	0	—	0	—

What is it indicated for?

For wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.

This single use device is for cementless use only.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052754 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052754: Wrist Fusion Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052754

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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