510(k) · Cleared

Cleared

Global FX Porous-Coated Humeral Stem

K011099510(k) TraditionalCleared Jul 6, 200186-day reviewClass II21 CFR 888.3670

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

DePuy Orthopaedics, Inc. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Jul 6, 2001 as substantially equivalent to K984541 (DePuy Orthopaedics, Inc., 1999) and 1 other predicate after an 86-day review. Its family tree reaches back 2 generations to 1991. 75 later devices descend from it.

Decided: Jul 6, 2001
Review: 86 days
Class: Class II
Product code: MBF
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K911686 (1991). 4 ancestors in all. 75 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 2 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
1 generation backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
This deviceK011099 Global FX Porous-Coated Humeral StemDePuy Orthopaedics, Inc. · 2001
Descendant · cites it directly · 71 of its ownK042021 Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · Recalled
Descendant · cites it directly · 26 of its ownK070565 Cofield Total Shoulder SystemSmith & Nephew, Inc. · 2007
Descendant · 2 generations on · 24 of its ownK093430 Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech…Exactech, Inc. · 2010 · Recalled
Descendant · 2 generations on · 22 of its ownK103419 Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · Recalled
Descendant · 3 generations on · 21 of its ownK111379 Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium…Exactech, Inc. · 2011 · Recalled

Showing 5 of 75 descendants. See all descendants

Descendants cleared per year

2004high 8 (2025) · low 0 (2005)2026

Most influential descendants

Showing 5 of 75 · See all

K042021Exactech Equinoxe Shoulder SystemExactech, Inc. · 2004 · cites it directly71descendants
K070565Cofield Total Shoulder SystemSmith & Nephew, Inc. · 2007 · cites it directly26descendants
K093430Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid…Exactech, Inc. · 2010 · 2 generations on24descendants
K103419Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TMExactech, Inc. · 2010 · 2 generations on22descendants
K111379Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…Exactech, Inc. · 2011 · 3 generations on21descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K911686	Global Total Shoulder, Uncement Humeral Hemi-Shoul	Depuy, Inc.	1991	—
−1	K984541	Global FX Humeral Stem, Global Advantage Humeral Head	DePuy Orthopaedics, Inc.	1999	—
0 (this device)	K011099	Global FX Porous-Coated Humeral Stem	DePuy Orthopaedics, Inc.	2001	—
+1	K042021	Exactech Equinoxe Shoulder System	Exactech, Inc.	2004	10
+1	K070565	Cofield Total Shoulder System	Smith & Nephew, Inc.	2007	—
+2	K093430	Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage…	Exactech, Inc.	2010	1
+2	K103419	Exactech Equinoxe R Uhmwpe Posterior Augment Pegged Glenoids TM	Exactech, Inc.	2010	2
+3	K111379	Equinoxe Uhmwpe 12* Posterior Augment Pegged Glenoid, Small / Medium / Large /…	Exactech, Inc.	2011	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2006	2	0
2007	1	0
2010	6	0
2011	4	0
2012	4	0
2013	1	0
2014	2	0
2015	4	0
2016	3	0
2017	2	0
2018	7	0
2019	3	0
2020	1	0
2021	4	0
2022	4	0
2023	7	0
2024	6	0
2025	8	0
2026	5	0

FIG. 1 — Lineage of K011099, 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.

Planning a device in MBF? 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 MBF device

#1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 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
*	K984541	Global FX Humeral Stem, Global Advantage Humeral Head Summary page 1 …Cemented. Semi-con-strained, SubstantiallyEquivalentDevices: GlobalFx Shoulder System K984541 PorousCoatedGlobalShoulder K943300 Device Description: The Porous-c…	DePuy Orthopaedics, Inc.	1999	—
*	K943300	Depuy Porous Coated Global Shoulder Summary page 1 …tDevices: GlobalFx Shoulder System K984541 PorousCoatedGlobalShoulder K943300 Device Description: The Porous-coated GlobalFx humerals…	Depuy, Inc.	1994	—

Also cleared against K984541: 9 other devices →

What descends from it? (75)

See all 75

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

Number	Device	Applicant	Decided	Descendants
K042021	Exactech Equinoxe Shoulder System	Exactech, Inc.	2004	71
K070565	Cofield Total Shoulder System	Smith & Nephew, Inc.	2007	26
K203230	Global Shoulder and Delta CTA systems	Depuy Lnc.	2021	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?

The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
None of the 4 ancestors has a recall.
Of its descendants, K042021 (Exactech, Inc., 2004) has gone furthest, with 71 descendants of its own.
9 other devices also cite its predicate K984541.

How does its category compare?

All MBF devices

MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBF

2in 2025

2007high 4 (2022) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBF

144in 2023

2007high 164 (2022) · low 144 (2023)2026

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

Recalls per year · MBF

1in 2023

2007high 8 (2022) · low 0 (2007)2026

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

Adverse event reports per year · MBF

255in 2025

2007high 255 (2025) · low 2 (2007)2025

MAUDE reports naming product code MBF, 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	2	—	0	2
2008	1	—	0	7
2009	1	—	1	16
2010	0	—	0	24
2011	0	—	0	32
2012	2	—	0	30
2013	1	—	0	40
2014	1	—	0	28
2015	0	—	0	49
2016	0	—	0	85
2017	2	—	1	193
2018	1	—	1	99
2019	2	—	2	47
2020	2	—	0	24
2021	1	—	0	36
2022	4	164	8	114
2023	4	144	1	143
2024	2	—	0	164
2025	2	—	0	255
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 shoulder…

Read the full statement (143 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).

4. Rotator cuff tear arthropathy.

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;

2. Awvascular necrosis of the humeral head.

Porocoat® Porous-Coated Components

Porocoat porous-coated humeral stem prostheses are indicated for cemented or cementless use with fixation provided by biological tissue in-growth into the porous coating.

Cemented Components

Humeral stem and Glenoid components labeled “For cemented use only” are indicated only for use with bone cement.

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/K011099 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011099: Global FX Porous-Coated Humeral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011099

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026