510(k) Report

510(k) · Cleared

Cleared

Depuy Porous Coated Global Shoulder

K943300510(k) TraditionalCleared Oct 31, 1994115-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, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented

Cleared on Oct 31, 1994 after a 115-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 273 devices in its family, counting itself, has a Class I recall. 272 later devices descend from it.

Decided
Oct 31, 1994
Review
115 days
Class
Class II
Product code
KWS
Recalls
None
Predicates
0

272 later devices descend from it, 2 citing it directly. 1 of the 273 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2001: 1 descendant cleared2003: 2 descendants cleared2021: 24 descendants cleared2007: 4 descendants cleared2004: 2 descendants cleared2013: 9 descendants cleared2017: 13 descendants cleared2014: 10 descendants cleared2019: 18 descendants cleared2011: 10 descendants cleared2005: 3 descendants cleared2006: 6 descendants cleared2015: 9 descendants cleared2012: 14 descendants cleared2010: 7 descendants cleared2018: 18 descendants cleared2008: 2 descendants cleared, 1 with a Class I recall12020: 19 descendants cleared2022: 20 descendants cleared2025: 19 descendants cleared2009: 1 descendant cleared2016: 10 descendants cleared2023: 17 descendants cleared2024: 15 descendants cleared2026: 19 descendants cleared1990200020102020
  1. This deviceK943300 Depuy Porous Coated Global ShoulderDepuy, Inc. · 1994
  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 272 descendants. See all descendants

Descendants cleared per year

2001: 12003: 22004: 22005: 32006: 62007: 42008: 22009: 12010: 72011: 102012: 142013: 92014: 102015: 92016: 102017: 132018: 182019: 182020: 192021: 242022: 202023: 172024: 152025: 192026: 19
2001high 24 (2021) · low 0 (2002)2026

Class I recalls in this family

  • K080642 Comprehensive Reverse Shoulder3 generations on · 2008

Most influential descendants

Showing 5 of 272 · 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)K943300Depuy Porous Coated Global ShoulderDepuy, Inc.1994—
+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
200110
200320
200420
200530
200660
200740
200821
200910
201070
2011100
2012140
201390
2014100
201590
2016100
2017130
2018180
2019180
2020190
2021240
2022200
2023170
2024150
2025190
2026190
FIG. 1 — Lineage of K943300, 1994–2026Source: 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? (272)

See all 272

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

NumberDeviceApplicantDecidedDescendants
K030710Bio-Modular Shoulder SystemBiomet, Inc.2003253
K011099Global FX Porous-Coated Humeral StemDePuy Orthopaedics, Inc.200175

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 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
  • K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0Smith & Nephew, Inc. · 2025
  • K241292MyShoulder Planner (5.3SSWPL)Medacta International S.A. · 2025

https://510kreport.com/device/K943300 · printed Nov 5, 2026

Cite this page

510(k) Report. “K943300: Depuy Porous Coated Global Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K943300

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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