510(k) Report

510(k) · Cleared

Cleared

Global Total Shoulder, Uncement Humeral Hemi-Shoul

K911686510(k) TraditionalCleared Jul 15, 199190-day reviewClass II21 CFR 888.3690

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

Depuy, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

Cleared on Jul 15, 1991 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 437 devices in its family, counting itself, has a Class I recall. 436 later devices descend from it.

Decided
Jul 15, 1991
Review
90 days
Class
Class II
Product code
HSD
Recalls
None
Predicates
0

436 later devices descend from it, 3 citing it directly. 1 of the 437 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2003: 3 descendants cleared1999: 2 descendants cleared2006: 15 descendants cleared2016: 17 descendants cleared2013: 23 descendants cleared2012: 20 descendants cleared2005: 4 descendants cleared2014: 21 descendants cleared2008: 11 descendants cleared, 1 with a Class I recall12007: 9 descendants cleared2010: 11 descendants cleared2011: 19 descendants cleared2021: 33 descendants cleared2001: 1 descendant cleared2022: 26 descendants cleared2004: 6 descendants cleared2002: 1 descendant cleared2017: 21 descendants cleared2018: 24 descendants cleared2015: 16 descendants cleared2019: 26 descendants cleared2025: 27 descendants cleared2009: 1 descendant cleared2020: 27 descendants cleared2026: 28 descendants cleared2024: 21 descendants cleared2023: 23 descendants cleared1990200020102020
  1. This deviceK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
  2. Descendant · cites it directly · 425 of its ownK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
  3. Descendant · cites it directly · 405 of its ownK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
  4. Descendant · 2 generations on · 338 of its ownK021478 Delta ShoulderDepuy, Inc. · 2003
  5. Descendant · 3 generations on · 295 of its ownK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
  6. Descendant · 3 generations on · 280 of its ownK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004

Showing 5 of 436 descendants. See all descendants

Descendants cleared per year

1999: 22001: 12002: 12003: 32004: 62005: 42006: 152007: 92008: 112009: 12010: 112011: 192012: 202013: 232014: 212015: 162016: 172017: 212018: 242019: 262020: 272021: 332022: 262023: 232024: 212025: 272026: 28
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 436 · See all
  • K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999 · cites it directly425descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K911686Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc.1991—
+1K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999—
+1K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage…DePuy Orthopaedics, Inc.1999—
+2K021478Delta ShoulderDepuy, Inc.2003—
+3K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc.2006—
+3K030941Aequalis Reversed Shoulder ProsthesisTornier2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200110
200210
200330
200460
200540
2006150
200790
2008111
200910
2010110
2011190
2012200
2013230
2014210
2015160
2016170
2017210
2018240
2019260
2020270
2021330
2022260
2023230
2024210
2025270
2026280
FIG. 1 — Lineage of K911686, 1991–2026Source: 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 HSD device

  1. #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (436)

See all 436

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

NumberDeviceApplicantDecidedDescendants
K984541Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc.1999425
K992065Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadDePuy Orthopaedics, Inc.1999405
K031971Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc.2003141

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?

  • Of its descendants, K984541 (DePuy Orthopaedics, Inc., 1999) has gone furthest, with 425 descendants of its own.

How does its category compare?

All HSD devices

HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HSD

1in 2024

2007: 42008: 32011: 22012: 22013: 42014: 12016: 32018: 12020: 22022: 12024: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HSD

145in 2016

2007: 72 days median2008: 92 days median2013: 218 days median2016: 145 days median
2007high 218 (2013) · low 72 (2007)2026

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

Recalls per year · HSD

1in 2020

2008: 22009: 22017: 32018: 12020: 1
2007high 3 (2017) · low 0 (2007)2026

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

Adverse event reports per year · HSD

757in 2025

2007: 1282008: 2592009: 1562010: 2252011: 2412012: 2542013: 2882014: 4342015: 5742016: 7842017: 9852018: 6492019: 8302020: 6582021: 5732022: 5082023: 5862024: 6932025: 757
2007high 985 (2017) · low 128 (2007)2025

MAUDE reports naming product code HSD, 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
20074720128
20083922259
20090—2156
20100—0225
20112—0241
20122—0254
201342180288
20141—0434
20150—0574
201631450784
20170—3985
20181—1649
20190—0830
20202—1658
20210—0573
20221—0508
20230—0586
20241—0693
20250—0757
20260—0—

More from Depuy, Inc.

719 FDA decisions under this applicant name. See the company

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  • P830055/S380LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S375LCS® Total Knee SystemDepuy, Inc. · 2026
  • P830055/S351Attune Revision Knee SystemDepuy, Inc. · 2026

Recent decisions in HSD

The HSD category page

  • K233260Univers Revers CA Head and AdapterArthrex, Inc. · 2024
  • K221232Univers Revers Humeral Cup ImplantArthrex, Inc. · 2022
  • K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
  • K193122Biocore9 Humeral Resurfacing SystemBiocore9, LLC · 2020
  • K173964OVOMotion Shoulder Arthroplasty SystemArthrosurface, Inc. · 2018

https://510kreport.com/device/K911686 · printed Nov 6, 2026

Cite this page

510(k) Report. “K911686: Global Total Shoulder, Uncement Humeral Hemi-Shoul.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911686

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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