510(k) Report

510(k) · Cleared

Cleared

Global Advantage Humeral Stem with Porocoat

K011047510(k) TraditionalCleared Jun 28, 200183-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 Jun 28, 2001 after an 83-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 260 devices in its family, counting itself, has a Class I recall. 259 later devices descend from it.

Decided
Jun 28, 2001
Review
83 days
Class
Class II
Product code
MBF
Recalls
None
Predicates
0

259 later devices descend from it, 5 citing it directly. 1 of the 260 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2021: 24 descendants cleared2014: 10 descendants cleared2003: 2 descendants cleared2022: 21 descendants cleared2007: 5 descendants cleared2013: 9 descendants cleared2017: 13 descendants cleared2019: 18 descendants cleared2011: 9 descendants cleared2005: 3 descendants cleared2004: 1 descendant cleared2006: 4 descendants cleared2015: 6 descendants cleared2012: 12 descendants cleared2010: 6 descendants cleared2020: 18 descendants cleared2018: 16 descendants cleared2016: 10 descendants cleared2008: 2 descendants cleared, 1 with a Class I recall12025: 19 descendants cleared2009: 1 descendant cleared2023: 17 descendants cleared2024: 14 descendants cleared2026: 19 descendants cleared200020052010201520202025
  1. This deviceK011047 Global Advantage Humeral Stem with PorocoatDePuy Orthopaedics, Inc. · 2001
  2. Descendant · cites it directly · 253 of its ownK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
  3. Descendant · 2 generations on · 176 of its ownK043100 Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid…Biomet, Inc. · 2005 · Recalled
  4. Descendant · 2 generations on · 175 of its ownK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
  5. Descendant · 3 generations on · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
  6. Descendant · 2 generations on · 138 of its ownK060692 Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · Recalled

Showing 5 of 259 descendants. See all descendants

Descendants cleared per year

2003: 22004: 12005: 32006: 42007: 52008: 22009: 12010: 62011: 92012: 122013: 92014: 102015: 62016: 102017: 132018: 162019: 182020: 182021: 242022: 212023: 172024: 142025: 192026: 19
2003high 24 (2021) · low 1 (2004)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder3 generations on · 2008

Most influential descendants

Showing 5 of 259 · See all
  • K030710Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · cites it directly253descendants
  • K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc. · 2005 · 2 generations on176descendants
  • K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007 · 2 generations on175descendants
  • K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 3 generations on172descendants
  • K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp · 2006 · 2 generations on138descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K011047Global Advantage Humeral Stem with PorocoatDePuy Orthopaedics, Inc.2001—
+1K030710Bio-Modular Shoulder SystemBiomet, Inc.20031
+2K043100Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid ComponentsBiomet, Inc.20051
+2K072804Comprehensive RS Shoulder SystemBiomet Manufacturing Corp2007—
+3K080642Comprehensive Reverse ShoulderBiomet, Inc.2008Class I
+2K060692Comprehensive Primary Shoulder StemsBiomet Manufacturing Corp20066

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200320
200410
200530
200640
200750
200821
200910
201060
201190
2012120
201390
2014100
201560
2016100
2017130
2018160
2019180
2020180
2021240
2022210
2023170
2024140
2025190
2026190
FIG. 1 — Lineage of K011047, 2001–2026Source: 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 MBF device

  1. #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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? (259)

See all 259

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

NumberDeviceApplicantDecidedDescendants
K030710Bio-Modular Shoulder SystemBiomet, Inc.2003253
K133834Depuy Global Unite Shoulder SystemDepuy (Ireland)201421
K063652Global AP Porous Coated Humeral StemDePuy Orthopaedics, Inc.200718
K212683GLOBAL ICON Stemless Shoulder SystemDepuy (Ireland)20220
K203230Global Shoulder and Delta CTA systemsDepuy Lnc.20210

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, K030710 (Biomet, Inc., 2003) has gone furthest, with 253 descendants of its own.

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

2007: 22008: 12009: 12012: 22013: 12014: 12017: 22018: 12019: 22020: 22021: 12022: 42023: 42024: 22025: 22026 (partial year): 1
2007high 4 (2022) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBF

144in 2023

2022: 164 days median2023: 144 days median
2007high 164 (2022) · low 144 (2023)2026

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

Recalls per year · MBF

1in 2023

2009: 12017: 12018: 12019: 22022: 82023: 1
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

2007: 22008: 72009: 162010: 242011: 322012: 302013: 402014: 282015: 492016: 852017: 1932018: 992019: 472020: 242021: 362022: 1142023: 1432024: 1642025: 255
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—02
20081—07
20091—116
20100—024
20110—032
20122—030
20131—040
20141—028
20150—049
20160—085
20172—1193
20181—199
20192—247
20202—024
20211—036
202241648114
202341441143
20242—0164
20252—0255
20261—0—

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Recent decisions in MBF

The MBF category page

  • K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive…Zimmer, Inc. · 2026
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  • K240876Identity Shoulder SystemZimmer, Inc. · 2024
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https://510kreport.com/device/K011047 · printed Nov 4, 2026

Cite this page

510(k) Report. “K011047: Global Advantage Humeral Stem with Porocoat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011047

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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