510(k) Report

510(k) · Cleared

Cleared

Global Advantage Extended Humeral Head

K000575510(k) TraditionalCleared Mar 10, 200017-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 Mar 10, 2000 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 308 devices in its family, counting itself, has a Class I recall. 307 later devices descend from it.

Decided
Mar 10, 2000
Review
17 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
0

307 later devices descend from it, 9 citing it directly. 1 of the 308 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2006: 2 descendants cleared2007: 4 descendants cleared2011: 10 descendants cleared2021: 29 descendants cleared2008: 9 descendants cleared, 1 with a Class I recall12005: 1 descendant cleared2012: 10 descendants cleared2020: 22 descendants cleared2019: 19 descendants cleared2013: 16 descendants cleared2017: 19 descendants cleared2025: 22 descendants cleared2010: 7 descendants cleared2016: 11 descendants cleared2022: 21 descendants cleared2018: 17 descendants cleared2024: 18 descendants cleared2023: 21 descendants cleared2015: 11 descendants cleared2009: 1 descendant cleared2014: 12 descendants cleared2026: 25 descendants cleared200020052010201520202025
  1. This deviceK000575 Global Advantage Extended Humeral HeadDePuy Orthopaedics, Inc. · 2000
  2. Descendant · cites it directly · 295 of its ownK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
  3. Descendant · cites it directly · 250 of its ownK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
  4. Descendant · 2 generations on · 191 of its ownK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
  5. Descendant · 2 generations on · 190 of its ownK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
  6. Descendant · 3 generations on · 177 of its ownK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled

Showing 5 of 307 descendants. See all descendants

Descendants cleared per year

2005: 12006: 22007: 42008: 92009: 12010: 72011: 102012: 102013: 162014: 122015: 112016: 112017: 192018: 172019: 192020: 222021: 292022: 212023: 212024: 182025: 222026: 25
2005high 29 (2021) · low 1 (2005)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder3 generations on · 2008

Most influential descendants

Showing 5 of 307 · See all
  • K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006 · cites it directly295descendants
  • K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · cites it directly250descendants
  • K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007 · 2 generations on191descendants
  • K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · 2 generations on190descendants
  • K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc. · 2008 · 3 generations on177descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K000575Global Advantage Extended Humeral HeadDePuy Orthopaedics, Inc.2000—
+1K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006—
+1K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.20078
+2K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc.2007—
+2K063569Equinoxe Reverse Shoulder SystemExactech, Inc.200713
+3K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc.20081

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200620
200740
200891
200910
201070
2011100
2012100
2013160
2014120
2015110
2016110
2017190
2018170
2019190
2020220
2021290
2022210
2023210
2024180
2025220
2026250
FIG. 1 — Lineage of K000575, 2000–2026Source: 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.

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 KWS device

  1. #1 K220847 AETOS Shoulder Systemscore 21.1 · 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (307)

See all 307

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

NumberDeviceApplicantDecidedDescendants
K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006295
K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc.2007250
K110847SMR Shoulder System - Cta Humeral HeadsLima Corporate S.P.A.201134
K051843Copeland Eas Humeral Resurfacing HeadsBiomet, Inc.20056
K073331Dvo Extended Articulation Humeral HeadsDvo Extremity Solutions, LLC20083
K082715Depuy Global AP Cta Humeral HeadDePuy Orthopaedics, Inc.20082
K080990Depuy Global C.AP. Cta Resurfacing ShoulderDePuy Orthopaedics, Inc.20082
K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210
K110706Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc.20110

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 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K062116 (DePuy Orthopaedics, Inc., 2006) has gone furthest, with 295 descendants of its own.

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

2007: 22008: 42009: 42010: 72011: 112012: 72013: 122014: 72015: 82016: 102017: 72018: 42019: 92020: 32021: 52022: 52023: 42024: 22025: 32026 (partial year): 2
2007high 12 (2013) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWS

97in 2025

2008: 37 days median2009: 108 days median2010: 33 days median2011: 90 days median2012: 86 days median2013: 120 days median2014: 89 days median2015: 129 days median2016: 114 days median2017: 120 days median2018: 152 days median2019: 106 days median2020: 98 days median2021: 151 days median2022: 158 days median2023: 250 days median2025: 97 days median
2007high 250 (2023) · low 33 (2010)2026

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

Recalls per year · KWS

2in 2023

2007: 212008: 292010: 102011: 112012: 102014: 12016: 12017: 42018: 12019: 22020: 52023: 22026 (partial year): 1
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

2007: 1582008: 2382009: 2942010: 3932011: 4862012: 5422013: 8182014: 1,0662015: 1,1702016: 9702017: 1,6812018: 1,5452019: 1,7282020: 1,5672021: 1,3582022: 1,2682023: 1,7502024: 2,1222025: 2,281
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—21158
200843729238
200941080294
201073310393
2011119011486
201278610542
2013121200818
201478911,066
2015812901,170
2016101141970
2017712041,681
2018415211,545
2019910621,728
202039851,567
2021515101,358
2022515801,268
2023425021,750
20242—02,122
202539702,281
20262—1—

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Recent decisions in KWS

The KWS category page

  • K260721Tornier Perform Advanced GlenoidTornier, Inc. · 2026
  • K254084AETOS Shoulder System - CONCELOC GlenoidsSmith & Nephew, Inc. · 2026
  • K252418Catalyst F1x Shoulder SystemCatalyst Orthoscience, Inc. · 2025
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https://510kreport.com/device/K000575 · printed Nov 6, 2026

Cite this page

510(k) Report. “K000575: Global Advantage Extended 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/K000575

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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