510(k) Report

510(k) · Cleared

Cleared

Shoulder Fixation System

K042059510(k) TraditionalCleared Sep 30, 200462-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, Inc. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

Cleared on Sep 30, 2004 after a 62-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 33 later devices descend from it.

Decided
Sep 30, 2004
Review
62 days
Class
Class II
Product code
LXT
Recalls
None
Predicates
0

33 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2005: 3 descendants cleared2023: 2 descendants cleared2026: 3 descendants cleared2006: 2 descendants cleared2012: 2 descendants cleared2015: 2 descendants cleared2017: 2 descendants cleared2018: 3 descendants cleared2025: 4 descendants cleared2021: 2 descendants cleared2024: 5 descendants cleared2020: 1 descendant cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK042059 Shoulder Fixation SystemHand Innovations, Inc. · 2004
  2. Descendant · cites it directly · 30 of its ownK051728 Modification to Shoulder Fixation SystemHand Innovations, LLC · 2005
  3. Descendant · 2 generations on · 25 of its ownK060290 Shoulder Fixation SystemHand Innovations, LLC · 2006
  4. Descendant · 3 generations on · 17 of its ownK143697 Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · Recalled
  5. Descendant · 3 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  6. Descendant · 4 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017

Showing 5 of 33 descendants. See all descendants

Descendants cleared per year

2005: 32006: 22010: 12012: 22015: 22017: 22018: 32020: 12021: 22022: 12023: 22024: 52025: 42026: 3
2005high 5 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 33 · See all
  • K051728Modification to Shoulder Fixation SystemHand Innovations, LLC · 2005 · cites it directly30descendants
  • K060290Shoulder Fixation SystemHand Innovations, LLC · 2006 · 2 generations on25descendants
  • K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · 3 generations on17descendants
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on14descendants
  • K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 4 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K042059Shoulder Fixation SystemHand Innovations, Inc.2004—
+1K051728Modification to Shoulder Fixation SystemHand Innovations, LLC2005—
+2K060290Shoulder Fixation SystemHand Innovations, LLC2006—
+3K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing201518
+3K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—
+4K173166ANTHEM Fracture SystemGlobus Medical, Inc.2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200530
200620
201010
201220
201520
201720
201830
202010
202120
202210
202320
202450
202540
202630
FIG. 1 — Lineage of K042059, 2004–2026Source: 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
Get a 510(k) Report

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? (33)

See all 33

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

NumberDeviceApplicantDecidedDescendants
K051728Modification to Shoulder Fixation SystemHand Innovations, LLC200530
K093978Exactech Equinoxe Proximal Humerus Fracture Plate SystemExactech, Inc.20104
K051412Humeral Head Plate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH20052

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, K051728 (Hand Innovations, LLC, 2005) has gone furthest, with 30 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 Hand Innovations, Inc.

10 FDA decisions under this applicant name. See the company

  • K050932Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 20051 recall
  • K041157Modification to Small Bone Fixation SystemHand Innovations, Inc. · 2004
  • K041081Fragment Plate System, Screws, Pins and K-WiresHand Innovations, Inc. · 20041 recall
  • K033406Small Bone Fixation SystemHand Innovations, Inc. · 2004
  • K032705Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003

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/K042059 · printed Nov 6, 2026

Cite this page

510(k) Report. “K042059: 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/K042059

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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