510(k) Report

510(k) · Cleared

Cleared

Arthrex Humeral Fracture Plates and Screws

K041965510(k) TraditionalCleared Sep 8, 200449-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

Arthrex, Inc. · HRS Plate, Fixation, Bone

Cleared on Sep 8, 2004 as substantially equivalent to K011334 (Synthes (Usa), 2001) and 4 other predicates after a 49-day review. Its family tree reaches back 1 generation to 1998. 35 later devices descend from it.

Decided
Sep 8, 2004
Review
49 days
Class
Class II
Product code
HRS
Recalls
None
Predicates
5

Its longest line of descent runs back 1 generation to K983853 (1998). 5 ancestors in all. 35 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 2 other ancestors2001: 2 other ancestors2005: 1 descendant cleared2015: 3 descendants cleared2016: 3 descendants cleared2008: 1 descendant cleared2017: 4 descendants cleared2023: 2 descendants cleared2026: 4 descendants cleared2025: 4 descendants cleared2019: 1 descendant cleared2022: 2 descendants cleared2018: 4 descendants cleared2020: 1 descendant cleared2024: 4 descendants cleared2021: 1 descendant clearedK983853 · Depuy Ace Timax Meta Plate · Depuy Ace Medical Co. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors 1 generation forward: 6 descendants2 generations forward: 15 descendants3 generations forward: 9 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants6 generations forward: 1 descendant K983853 · Depuy Ace Timax Meta Plate · Depuy Ace Medical Co. · 19980+5
  1. Root · 1 generation backK983853 Depuy Ace Timax Meta PlateDepuy Ace Medical Co. · 1998
  2. This deviceK041965 Arthrex Humeral Fracture Plates and ScrewsArthrex, Inc. · 2004
  3. Descendant · cites it directly · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
  4. Descendant · 2 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
  5. Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
  6. Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
  7. Descendant · 3 generations on · 7 of its ownK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021

Showing 5 of 35 descendants. See all descendants

Descendants cleared per year

2005: 12008: 12015: 32016: 32017: 42018: 42019: 12020: 12021: 12022: 22023: 22024: 42025: 42026: 4
2005high 4 (2017) · low 0 (2006)2026

Most influential descendants

Showing 5 of 35 · See all
  • K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly14descendants
  • K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on11descendants
  • K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
  • K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
  • K212433Anthem Fracture SystemGlobus Medical, Inc. · 2021 · 3 generations on7descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K983853Depuy Ace Timax Meta PlateDepuy Ace Medical Co.1998—
0 (this device)K041965Arthrex Humeral Fracture Plates and ScrewsArthrex, Inc.2004—
+1K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.2017—
+2K173166ANTHEM Fracture SystemGlobus Medical, Inc.2017—
+2K180554ANTHEM Fracture SystemGlobus Medical, Inc.2018—
+2K202496ANTHEM Fracture SystemGlobus Medical, Inc.2020—
+3K212433Anthem Fracture SystemGlobus Medical, Inc.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120
200320

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200810
201530
201630
201740
201840
201910
202010
202110
202220
202320
202440
202540
202640
FIG. 1 — Lineage of K041965, 1998–2026Source: 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), 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 HRS? 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 HRS device

  1. #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K011334Synthes Curved Reconstruction Plate
Summary page 1
…Tissue Smooth or threaded metallic bone fixation fastener PREDICATE DEVICES: K01 1334 Synthes Curved Reconstruction Plate K031178 Synthes 3.5mm Broad LCP & 4.5mm CLP Distal Humerus Plate K032559 Synthes 4.…
Synthes (Usa)2001—
*K031178Synthes (Usa) 3.5 MM Broad LCP & 4.5 MM LCP Distal Humerus Plates
Summary page 1
…Smooth or threaded metallic bone fixation fastener PREDICATE DEVICES: K01 1334 Synthes Curved Reconstruction Plate K031178 Synthes 3.5mm Broad LCP & 4.5mm CLP Distal Humerus Plate K032559 Synthes 4.0mm Titanium Locking Screws K01 1170 Synthes…
Synthes (Usa)2003—
*K032559Synthes 4.0MM Titanium (TI.) Locking Screws
Summary page 1
…bone fixation fastener PREDICATE DEVICES: K01 1334 Synthes Curved Reconstruction Plate K031178 Synthes 3.5mm Broad LCP & 4.5mm CLP Distal Humerus Plate K032559 Synthes 4.0mm Titanium Locking Screws K01 1170 Synthes 2.7mm LC-DCP, 3.5mm Profile Plate K983853 DePuy ACE TiMAXTM Meta…
Synthes (Usa)2003—
*K011170Synthes 2.7 MM LC-DCP, 3.5 MM Profile
Summary page 1
…01 1334 Synthes Curved Reconstruction Plate K031178 Synthes 3.5mm Broad LCP & 4.5mm CLP Distal Humerus Plate K032559 Synthes 4.0mm Titanium Locking Screws K01 1170 Synthes 2.7mm LC-DCP, 3.5mm Profile Plate K983853 DePuy ACE TiMAXTM Meta Plate DEVICE DESCRIPTION AND INTENDED USE: The Art…
Synthes (Usa)2001—
*K983853Depuy Ace Timax Meta Plate
Summary page 1
…Synthes 3.5mm Broad LCP & 4.5mm CLP Distal Humerus Plate K032559 Synthes 4.0mm Titanium Locking Screws K01 1170 Synthes 2.7mm LC-DCP, 3.5mm Profile Plate K983853 DePuy ACE TiMAXTM Meta Plate DEVICE DESCRIPTION AND INTENDED USE: The Arthrex Humeral Fracture Plate is designed as a spoon shap…
Depuy Ace Medical Co.1998—

Also cleared against K011334: 4 other devices →

What descends from it? (35)

See all 35

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

NumberDeviceApplicantDecidedDescendants
K163361ANTHEM™ Fracture SystemGlobus Medical, Inc.201714
K141493Proximal Humerus Plating SystemMiami Device Solutions20157
K150456Arthrex Plates, Screws, and StaplesArthrex, Inc.20156
K051412Humeral Head Plate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH20052
K161058Cannulated ScrewMiami Device Solutions, LLC20161
K073432Trauson Bone PlateTrauson (Jiangsu) Medical Instrument Co., Ltd.20081

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?

  • None of the 5 ancestors has a recall.
  • Of its descendants, K163361 (Globus Medical, Inc., 2017) has gone furthest, with 14 descendants of its own.
  • 4 other devices also cite its predicate K011334.

How does its category compare?

All HRS devices

HRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRS

54in 2025

2007: 352008: 352009: 472010: 492011: 432012: 592013: 562014: 762015: 562016: 442017: 572018: 402019: 462020: 482021: 402022: 472023: 402024: 542025: 542026 (partial year): 51
2007high 76 (2014) · low 35 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRS

90in 2025

2007: 63 days median2008: 87 days median2009: 85 days median2010: 100 days median2011: 88 days median2012: 106 days median2013: 89 days median2014: 57 days median2015: 97 days median2016: 109 days median2017: 122 days median2018: 116 days median2019: 89 days median2020: 88 days median2021: 87 days median2022: 144 days median2023: 120 days median2024: 96 days median2025: 90 days median2026 (partial year): 82 days median
2007high 144 (2022) · low 57 (2014)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HRS

1in 2025

2007: 22008: 112009: 32010: 162011: 52012: 42013: 112015: 72016: 52017: 32018: 22019: 252020: 12021: 92022: 32023: 12025: 12026 (partial year): 3
2007high 25 (2019) · low 0 (2014)2026

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

Adverse event reports per year · HRS

2,306in 2025

2007: 3392008: 3112009: 4352010: 4912011: 7732012: 1,6632013: 2,6432014: 2,4132015: 3,0952016: 2,2762017: 2,2202018: 2,6632019: 3,3592020: 2,7902021: 2,4422022: 1,7002023: 2,0492024: 1,8492025: 2,306
2007high 3,359 (2019) · low 311 (2008)2025

MAUDE reports naming product code HRS, 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
200735632339
2008358711311
200947853435
20104910016491
201143885773
20125910641,663
20135689112,643
2014765702,413
2015569773,095
20164410952,276
20175712232,220
20184011622,663
20194689253,359
2020488812,790
2021408792,442
20224714431,700
20234012012,049
2024549601,849
2025549012,306
202651823—

What is it indicated for?

The Arthrex Humeral Fracture Plates and Screws are intended to provide internal fixation of proximal fractures of the humerus.

Indications for use as stated in the FDA summary.

Also cleared against K011334

4 other devices cite the same predicate.

  • K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
  • K052368Olecranonplate with Angular StabilityI.T.S. Implantat-Technologie-Systeme GmbH · 20051 recall
  • K050852Claviculaplate with Angular Stablity Bone Plate SystemI.T.S. Implantat-Technologie-Systeme GmbH · 20051 recall
  • K012655Congruent Bone Plate SystemAcu Med, Inc. · 200116 recalls

More from Arthrex, Inc.

355 FDA decisions under this applicant name. See the company

  • K262975Arthrex Beaming SystemArthrex, Inc. · 2026
  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K262451Arthrex DynaNite StaplesArthrex, Inc. · 2026
  • K262357Arthrex Bioabsorbable PushLock Suture AnchorsArthrex, Inc. · 2026
  • K260624Arthrex Radial Head Replacement SystemArthrex, Inc. · 2026

Recent decisions in HRS

The HRS category page

  • K262779ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2026
  • K263407Tempo Plating SystemPace Surgical · 2026
  • K263269Park's Pectus SystemTdm Co., Ltd. · 2026
  • K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd. · 2026
  • K262649Alians ForearmNewclip Technics · 2026

https://510kreport.com/device/K041965 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041965: Arthrex Humeral Fracture Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041965

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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