510(k) · Cleared

Cleared

Global FX Humeral Stem, Global Advantage Humeral Head

K984541510(k) SpecialCleared Jan 14, 199924-day reviewClass II21 CFR 888.3650

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DePuy Orthopaedics, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Cleared on Jan 14, 1999 as substantially equivalent to K911686 (Depuy, Inc., 1991) and 1 other predicate after a 24-day review. Its family tree reaches back 1 generation to 1991. 1 of the 428 devices in its family, counting itself, has a Class I recall. 425 later devices descend from it.

Decided: Jan 14, 1999
Review: 24 days
Class: Class II
Product code: KWT
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K911686 (1991). 2 ancestors in all. 425 later devices descend from it, 10 citing it directly. 1 of the 428 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 1 generation backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
This deviceK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
Descendant · cites it directly · 405 of its ownK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
Descendant · 2 generations on · 338 of its ownK021478 Delta ShoulderDepuy, Inc. · 2003
Descendant · 3 generations on · 295 of its ownK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
Descendant · 3 generations on · 280 of its ownK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
Descendant · 3 generations on · 277 of its ownK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004

Showing 5 of 425 descendants. See all descendants

Descendants cleared per year

1999high 33 (2021) · low 0 (2000)2026

Class I recalls in this family

K080642 Comprehensive Reverse Shoulder4 generations on · 2008

Most influential descendants

Showing 5 of 425 · See all

K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadDePuy Orthopaedics, Inc. · 1999 · cites it directly405descendants
K021478Delta ShoulderDepuy, Inc. · 2003 · 2 generations on338descendants
K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006 · 3 generations on295descendants
K030941Aequalis Reversed Shoulder ProsthesisTornier · 2004 · 3 generations on280descendants
K041873Aequalis Reversed Shoulder ProsthesisTornier · 2004 · 3 generations on277descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K911686	Global Total Shoulder, Uncement Humeral Hemi-Shoul	Depuy, Inc.	1991	—
0 (this device)	K984541	Global FX Humeral Stem, Global Advantage Humeral Head	DePuy Orthopaedics, Inc.	1999	—
+1	K992065	Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…	DePuy Orthopaedics, Inc.	1999	—
+2	K021478	Delta Shoulder	Depuy, Inc.	2003	—
+3	K062116	Delta Cta Reverse Shoulder System Humeral Heads	DePuy Orthopaedics, Inc.	2006	—
+3	K030941	Aequalis Reversed Shoulder Prosthesis	Tornier	2004	—
+3	K041873	Aequalis Reversed Shoulder Prosthesis	Tornier	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0
2001	1	0
2002	1	0
2003	1	0
2004	6	0
2005	3	0
2006	12	0
2007	8	0
2008	11	1
2009	1	0
2010	11	0
2011	19	0
2012	20	0
2013	21	0
2014	20	0
2015	16	0
2016	17	0
2017	21	0
2018	24	0
2019	26	0
2020	27	0
2021	33	0
2022	26	0
2023	23	0
2024	21	0
2025	27	0
2026	28	0

FIG. 1 — Lineage of K984541, 1991–2026Source: 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.

1 device in this family has a Class I recall. 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 KWT device

#1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (2)

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
*	K911686	Global Total Shoulder, Uncement Humeral Hemi-Shoul Summary page 1 …ral, Metallic Uncemented (Class II) 87 KWS Prosthesis, Shoulder, Semi- Constrained, Metal/Polymer Cemented (Class III) SUBSTANTIALLY EQUIVALENT DEVICE: Global Shoulder: K911686, K914695 DEVICE DESCRIPTION: The Global Shoulder components, which are the subjects of this submission, consist of a humeral bo…	Depuy, Inc.	1991	—
*	K914695	Global Total Shoulder Summary page 1 …llic Uncemented (Class II) 87 KWS Prosthesis, Shoulder, Semi- Constrained, Metal/Polymer Cemented (Class III) SUBSTANTIALLY EQUIVALENT DEVICE: Global Shoulder: K911686, K914695 DEVICE DESCRIPTION: The Global Shoulder components, which are the subjects of this submission, consist of a humeral body (stem)…	Depuy, Inc.	1992	—

Also cleared against K911686: 2 other devices →

What descends from it? (425)

See all 425

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

Number	Device	Applicant	Decided	Descendants
K992065	Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head	DePuy Orthopaedics, Inc.	1999	405
K023063	Comprehensive Humeral Fracture System	Biomet Orthopedics, Inc.	2002	146
K011099	Global FX Porous-Coated Humeral Stem	DePuy Orthopaedics, Inc.	2001	75
K042021	Exactech Equinoxe Shoulder System	Exactech, Inc.	2004	71
K111212	SMR Shoulder System- Revision Stems	Lima Corporate S.P.A.	2011	33
K093599	Arrow Anatomical Shoulder System	Fournitures Hospitalieres Industrie	2010	11
K062029	Anatomical Shoulder Fracture System	Zimmer GmbH	2006	10
K212683	GLOBAL ICON Stemless Shoulder System	Depuy (Ireland)	2022	0
K203230	Global Shoulder and Delta CTA systems	Depuy Lnc.	2021	0
K131277	Seviin Fracture Shoulder	Ingen Orthopedics, LLC	2013	0

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 4 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K992065 (DePuy Orthopaedics, Inc., 1999) has gone furthest, with 405 descendants of its own.
2 other devices also cite its predicate K911686.

How does its category compare?

All KWT devices

KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWT

4in 2025

2007high 5 (2011) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWT

242in 2025

2007high 242 (2025) · low 91 (2019)2026

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

Recalls per year · KWT

1in 2023

2007high 7 (2010) · low 0 (2007)2026

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

Adverse event reports per year · KWT

749in 2025

2007high 749 (2025) · low 32 (2007)2025

MAUDE reports naming product code KWT, 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	—	0	32
2008	0	—	1	48
2009	0	—	0	58
2010	1	—	7	71
2011	5	165	0	112
2012	1	—	2	83
2013	1	—	1	113
2014	1	—	0	168
2015	2	—	0	176
2016	2	—	1	445
2017	1	—	1	560
2018	2	—	1	480
2019	4	91	3	419
2020	1	—	0	215
2021	1	—	0	228
2022	1	—	0	273
2023	1	—	1	361
2024	1	—	0	601
2025	4	242	0	749
2026	1	—	0	—

What is it indicated for?

Total or hemi-shoulder replacement is indicated for: 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory; 3. Other difficult clinical problems where…

Read the full statement (152 words)

Total or hemi-shoulder replacement is indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;

2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory;

3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;

2. Avascular necrosis of the humeral head.

Only the titanium alloy humeral stem components and the cobalt-chrome alloy humeral stem components, which are marketed under the Global Shoulder name, are intended for press-fit or cemented fixation. The glenoid components are for cemented use only.

CAUTION:

The cobalt-chrome alloy humeral components, which are marketed under the HRP Shoulder name and all glenoid components are for

CEMENTED USE ONLY.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K984541 · printed Nov 6, 2026

Cite this page

510(k) Report. “K984541: Global FX Humeral Stem, Global Advantage Humeral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984541

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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