510(k) · Cleared
ClearedGlobal Total Shoulder Eccentric Humeral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Jan 22, 1998 after a 90-day review. The FDA summary names its predicate without a number. 1 of the 441 devices in its family, counting itself, has a Class I recall. 440 later devices descend from it.
- Decided
- Jan 22, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 0
440 later devices descend from it, 4 citing it directly. 1 of the 441 devices in this family, counting this one, has a Class I recall.
- This deviceK974044 Global Total Shoulder Eccentric Humeral HeadDePuy Orthopaedics, Inc. · 1998
- Descendant · cites it directly · 405 of its ownK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- Descendant · 2 generations on · 338 of its ownK021478 Delta ShoulderDepuy, Inc. · 2003
- Descendant · 3 generations on · 295 of its ownK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- Descendant · 3 generations on · 280 of its ownK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · 3 generations on · 277 of its ownK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
Showing 5 of 440 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder3 generations on · 2008
Most influential descendants
Showing 5 of 440 · See all- 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
- K041873Aequalis Reversed Shoulder ProsthesisTornier · 2004 · 3 generations on277descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974044 | Global Total Shoulder Eccentric Humeral Head | DePuy Orthopaedics, Inc. | 1998 | — |
| +1 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| +2 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| +3 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| +3 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +3 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 5 | 0 |
| 2005 | 6 | 0 |
| 2006 | 14 | 0 |
| 2007 | 9 | 0 |
| 2008 | 11 | 1 |
| 2009 | 2 | 0 |
| 2010 | 11 | 0 |
| 2011 | 20 | 0 |
| 2012 | 20 | 0 |
| 2013 | 21 | 0 |
| 2014 | 20 | 0 |
| 2015 | 17 | 0 |
| 2016 | 18 | 0 |
| 2017 | 22 | 0 |
| 2018 | 25 | 0 |
| 2019 | 27 | 0 |
| 2020 | 28 | 0 |
| 2021 | 33 | 0 |
| 2022 | 26 | 0 |
| 2023 | 24 | 0 |
| 2024 | 21 | 0 |
| 2025 | 27 | 0 |
| 2026 | 28 | 0 |
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.
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 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
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 | Decided |
|---|---|---|---|
| * | — | DePuy Global Total Shoulder Named without a submission number | |
| * | — | DePuy Global Total Shoulder, Humeral Component, for Cemented or Uncemented Use Named without a submission number | |
| * | — | Global Total Shoulder (standard) Humeral Head Named without a submission number |
What descends from it? (440)
See all 4404 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K992065 (DePuy Orthopaedics, Inc., 1999) has gone furthest, with 405 descendants of its own.
How does its category compare?
All KWS devicesKWS 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
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 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?
The humeral components of the Global Total Shoulder are intended for cemented or cementless use as a total or herni-shoulder replacement which is indicated for: 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis; 2. Fracture-dislocations of the proximal humerus where the articular surfaces are severely comminuted, separated from blood supply or where experience shows more…
Read the full statement (129 words)
The humeral components of the Global Total Shoulder are intended for cemented or cementless use as a total or herni-shoulder replacement which is indicated for:
1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic arthritis, or rheumatoid arthritis;
2. Fracture-dislocations of the proximal humerus where the articular surfaces are severely comminuted, separated from blood supply or where experience shows more conventional methods of treatment are unsatisfactory;
3. Other difficult clinical management problems where arthrodesis or resection are not acceptable (i.e., revision of a failed primary component).
The glenoid components of the Global Total Shoulder are intended for cemented use only for the above indications.
Hemi-shoulder replacement is also indicated for:
1. Ununited humeral head fractures of long duration;
2. Avascular necrosis of the humeral head.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974044 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974044: Global Total Shoulder Eccentric 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/K974044
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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