510(k) · Cleared

Cleared

Modification to Shoulder Fixation System

K051728510(k) SpecialCleared Jul 20, 200523-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

Hand Innovations, LLC · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Cleared on Jul 20, 2005 as substantially equivalent to K042059 (Hand Innovations, Inc., 2004) after a 23-day review. Its family tree reaches back 1 generation to 2004. 30 later devices descend from it.

Decided: Jul 20, 2005
Review: 23 days
Class: Class II
Product code: LXT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K042059 (2004). 30 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK042059 Shoulder Fixation SystemHand Innovations, Inc. · 2004
This deviceK051728 Modification to Shoulder Fixation SystemHand Innovations, LLC · 2005
Descendant · cites it directly · 25 of its ownK060290 Shoulder Fixation SystemHand Innovations, LLC · 2006
Descendant · 2 generations on · 17 of its ownK143697 Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · Recalled
Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 3 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
Descendant · 3 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018

Showing 5 of 30 descendants. See all descendants

Descendants cleared per year

2005high 5 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 30 · See all

K060290Shoulder Fixation SystemHand Innovations, LLC · 2006 · cites it directly25descendants
K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · 2 generations on17descendants
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants
K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on11descendants
K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 3 generations on10descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K042059	Shoulder Fixation System	Hand Innovations, Inc.	2004	—
0 (this device)	K051728	Modification to Shoulder Fixation System	Hand Innovations, LLC	2005	—
+1	K060290	Shoulder Fixation System	Hand Innovations, LLC	2006	—
+2	K143697	Biomet Proximal Humerus Plating System	Biomet Manufacturing	2015	18
+2	K163361	ANTHEM™ Fracture System	Globus Medical, Inc.	2017	—
+3	K173166	ANTHEM Fracture System	Globus Medical, Inc.	2017	—
+3	K180554	ANTHEM Fracture System	Globus Medical, Inc.	2018	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2006	2	0
2010	1	0
2012	2	0
2015	2	0
2017	2	0
2018	3	0
2020	1	0
2021	2	0
2022	1	0
2023	2	0
2024	5	0
2025	4	0
2026	2	0

FIG. 1 — Lineage of K051728, 2004–2026Source: 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

Get a 510(k) Report

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
*	K042059	Shoulder Fixation System Summary page 1 …em Plate Fixation Bone Name of The device is substantially equivalent to: Predicate * Shoulder Fixation System (510(k) # K042059 - September 30, 2004) - Hand Devices Innovations, Inc. Classification Class II. Performance…	Hand Innovations, Inc.	2004	—

Also cleared against K042059: 2 other devices →

What descends from it? (30)

See all 30

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

Number	Device	Applicant	Decided	Descendants
K060290	Shoulder Fixation System	Hand Innovations, LLC	2006	25
K093978	Exactech Equinoxe Proximal Humerus Fracture Plate System	Exactech, Inc.	2010	4
K063095	Humerus Locking Plating System	Newclip Technics	2006	4
K052294	Shoulder Nail Plate	Hand Innovations, LLC	2005	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, K060290 (Hand Innovations, LLC, 2006) has gone furthest, with 25 descendants of its own.
2 other devices also cite its predicate K042059.

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?

The Modified Shoulder Fixation System is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal Humerus.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K051728 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051728: Modification to Shoulder Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051728

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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