510(k) · Cleared

Cleared

Depuy Global AP Shoulder System

K060874510(k) TraditionalCleared Jun 28, 200690-day reviewClass II21 CFR 888.3660

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

DePuy Orthopaedics, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Jun 28, 2006 as substantially equivalent to K992065 (DePuy Orthopaedics, Inc., 1999) and 2 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1991. 200 later devices descend from it.

Decided: Jun 28, 2006
Review: 90 days
Class: Class II
Product code: KWS
Recalls: None
Predicates: 3

Its longest line of descent runs back 3 generations to K911686 (1991). 9 ancestors in all. 200 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 3 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
2 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
1 generation backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
This deviceK060874 Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc. · 2006
Descendant · cites it directly · 162 of its ownK063081 Aequalis Shoulder SystemTornier · 2006
Descendant · 2 generations on · 120 of its ownK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
Descendant · 2 generations on · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
Descendant · 3 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
Descendant · 3 generations on · 105 of its ownK113413 Ascend Shoulder SystemTornier, Inc. · 2012

Showing 5 of 200 descendants. See all descendants

Descendants cleared per year

2006high 20 (2025) · low 0 (2008)2026

Most influential descendants

Showing 5 of 200 · See all

K063081Aequalis Shoulder SystemTornier · 2006 · cites it directly162descendants
K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007 · 2 generations on120descendants
K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · 2 generations on110descendants
K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 3 generations on108descendants
K113413Ascend Shoulder SystemTornier, Inc. · 2012 · 3 generations on105descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K911686	Global Total Shoulder, Uncement Humeral Hemi-Shoul	Depuy, Inc.	1991	—
−2	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	—
0 (this device)	K060874	Depuy Global AP Shoulder System	DePuy Orthopaedics, Inc.	2006	—
+1	K063081	Aequalis Shoulder System	Tornier	2006	—
+2	K071147	Nexa Orthopedics Total Shoulder System	Nexa Orthopedics, Inc.	2007	—
+2	K102924	Aequalis Ascend Modular Anatomic Shoulder System	Tornier, Inc.	2011	—
+3	K110599	Aequalis Ascend Modular Reverse Shoulder System	Tornier, Inc.	2011	—
+3	K113413	Ascend Shoulder System	Tornier, Inc.	2012	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1992	1	0
1998	1	0
1999	1	0
2001	2	0
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	2	0
2010	1	0
2011	5	0
2012	4	0
2013	8	0
2014	6	0
2015	9	0
2016	9	0
2017	10	0
2018	9	0
2019	14	0
2020	15	0
2021	18	0
2022	17	0
2023	17	0
2024	15	0
2025	20	0
2026	20	0

FIG. 1 — Lineage of K060874, 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 KWS? 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 KWS device

#1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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? (3)

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
*	K992065	Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head Summary page 2 …. BASIS OF SUBSTANTIAL EQUIVALENCE: The Depuy Global APTM Shoulder System is substantially equivalent to the previously cleared DePuy Global Advantage Shoulder System (K992065), the Sulzer Anatomical Shoulder System with Removable Heads (K030259), and the Sulzer Orthopedics Anatomica Humeral Stem/Head (K…	DePuy Orthopaedics, Inc.	1999	—
*	K030259	Amatomical Shoulder with Removable Head Summary page 2 …ystem is substantially equivalent to the previously cleared DePuy Global Advantage Shoulder System (K992065), the Sulzer Anatomical Shoulder System with Removable Heads (K030259), and the Sulzer Orthopedics Anatomica Humeral Stem/Head (K990137) based upon intended use, indications for use, design, material…	Centerplus Orthopedics, Inc.	2003	3
*	K990137	Anatomica Humeral Stem/Head Components Summary page 2 …Global Advantage Shoulder System (K992065), the Sulzer Anatomical Shoulder System with Removable Heads (K030259), and the Sulzer Orthopedics Anatomica Humeral Stem/Head (K990137) based upon intended use, indications for use, design, materials, packaging and sterilization. The subject device does not raise…	Sulzer Orthopedics, Inc.	1999	—

Also cleared against K992065: 13 other devices →

What descends from it? (200)

See all 200

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

Number	Device	Applicant	Decided	Descendants
K063081	Aequalis Shoulder System	Tornier	2006	162
K123122	Glenoid Intelligent Reusable Instrument System (Glenoid Iris)	Cleveland Clinic	2013	56
K123814	Humelock II Cemented Shoulder System	Fx Solutions	2013	32
K130759	Humelock II Cementless Shoulder System	Fx Solutions	2013	31
K063652	Global AP Porous Coated Humeral Stem	DePuy Orthopaedics, Inc.	2007	18
K101996	Depuy Global Unite Shoulder System	Depuy (Ireland)	2010	16
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 15 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
2 of the 9 ancestors have a recall of any class.
Of its descendants, K063081 (Tornier, 2006) has gone furthest, with 162 descendants of its own.
13 other devices also cite its predicate K992065.

How does its category compare?

All KWS devices

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

FDA decisions per year · KWS

3in 2025

2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2007high 250 (2023) · low 33 (2010)2026

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

Recalls per year · KWS

2in 2023

2007high 29 (2008) · low 0 (2009)2026

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

Adverse event reports per year · KWS

2,281in 2025

2007high 2,281 (2025) · low 158 (2007)2025

MAUDE reports naming product code KWS, 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	—	21	158
2008	4	37	29	238
2009	4	108	0	294
2010	7	33	10	393
2011	11	90	11	486
2012	7	86	10	542
2013	12	120	0	818
2014	7	89	1	1,066
2015	8	129	0	1,170
2016	10	114	1	970
2017	7	120	4	1,681
2018	4	152	1	1,545
2019	9	106	2	1,728
2020	3	98	5	1,567
2021	5	151	0	1,358
2022	5	158	0	1,268
2023	4	250	2	1,750
2024	2	—	0	2,122
2025	3	97	0	2,281
2026	2	—	1	—

What is it indicated for?

Total Shoulder 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…

Read the full statement (138 words)

Total Shoulder 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).

The humeral components of the Global APTM Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement.

Glenoid components of the Global APTM Shoulder are indicated only for use with bone cement for the above indications.

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;

2. Avascular necrosis of the humeral head.

3. Deformity and/or limited motion.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K060874 · printed Nov 6, 2026

Cite this page

510(k) Report. “K060874: Depuy Global AP Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060874

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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