510(k) · Cleared
ClearedGlobal Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric 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 Jul 12, 1999 as substantially equivalent to K911686 (Depuy, Inc., 1991) and 2 other predicates after a 24-day review. Its family tree reaches back 2 generations to 1991. 1 of the 410 devices in its family, counting itself, has a Class I recall. 405 later devices descend from it.
- Decided
- Jul 12, 1999
- Review
- 24 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K911686 (1991). 4 ancestors in all. 405 later devices descend from it, 14 citing it directly. 1 of the 410 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 1 generation backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- This deviceK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- Descendant · cites it directly · 338 of its ownK021478 Delta ShoulderDepuy, Inc. · 2003
- Descendant · 2 generations on · 295 of its ownK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- Descendant · 2 generations on · 280 of its ownK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · 2 generations on · 277 of its ownK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · cites it directly · 250 of its ownK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
Showing 5 of 405 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 405 · See all- K021478Delta ShoulderDepuy, Inc. · 2003 · cites it directly338descendants
- K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006 · 2 generations on295descendants
- K030941Aequalis Reversed Shoulder ProsthesisTornier · 2004 · 2 generations on280descendants
- K041873Aequalis Reversed Shoulder ProsthesisTornier · 2004 · 2 generations on277descendants
- K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · cites it directly250descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −1 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| 0 (this device) | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| +1 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| +2 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| +2 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +2 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +1 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 10 | 0 |
| 2007 | 7 | 0 |
| 2008 | 11 | 1 |
| 2009 | 1 | 0 |
| 2010 | 11 | 0 |
| 2011 | 19 | 0 |
| 2012 | 20 | 0 |
| 2013 | 20 | 0 |
| 2014 | 18 | 0 |
| 2015 | 15 | 0 |
| 2016 | 17 | 0 |
| 2017 | 21 | 0 |
| 2018 | 23 | 0 |
| 2019 | 25 | 0 |
| 2020 | 26 | 0 |
| 2021 | 32 | 0 |
| 2022 | 25 | 0 |
| 2023 | 22 | 0 |
| 2024 | 21 | 0 |
| 2025 | 25 | 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 |
|---|---|---|---|
| * | K911686 | Global Total Shoulder, Uncement Humeral Hemi-ShoulSummary page 1…ral, Metallic Uncemented (Class II) 87 KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (Class III) SUBSTANTIALLY EQUIVALENT DEVICE: Global Shoulder: K911686, K974044, K984541 DEVICE DESCRIPTION: The Global Advantage Shoulder consists of a humeral stem and a humeral head. Like the pred… | 1991 |
| * | K974044 | Global Total Shoulder Eccentric Humeral HeadSummary page 1…llic Uncemented (Class II) 87 KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (Class III) SUBSTANTIALLY EQUIVALENT DEVICE: Global Shoulder: K911686, K974044, K984541 DEVICE DESCRIPTION: The Global Advantage Shoulder consists of a humeral stem and a humeral head. Like the predicate dev… | 1998 |
| * | K984541 | Global FX Humeral Stem, Global Advantage Humeral HeadSummary page 1…mented (Class II) 87 KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented (Class III) SUBSTANTIALLY EQUIVALENT DEVICE: Global Shoulder: K911686, K974044, K984541 DEVICE DESCRIPTION: The Global Advantage Shoulder consists of a humeral stem and a humeral head. Like the predicate devices, the… | 1999 |
What descends from it? (405)
See all 40514 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021478 | Delta Shoulder | 2003 | 338 |
| K062250 | Delta Xtend Reverse Shoulder System | 2007 | 250 |
| K060874 | Depuy Global AP Shoulder System | 2006 | 200 |
| K060988 | Total and Hemi Shoulder System | 2006 | 194 |
| K071379 | Delta Xtend Reverse Shoulder Modular Stem | 2007 | 191 |
| K042021 | Exactech Equinoxe Shoulder System | 2004 | 71 |
| K103835 | Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C… | 2011 | 43 |
| K111097 | Humelock Cemented Shoulder Prosthesis | 2011 | 34 |
| K133834 | Depuy Global Unite Shoulder System | 2014 | 21 |
| K093599 | Arrow Anatomical Shoulder System | 2010 | 11 |
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 7.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K021478 (Depuy, Inc., 2003) has gone furthest, with 338 descendants of its own.
- 2 other devices also cite its predicate K911686.
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?
Total or hemi-shoulder replacement is indicated for: 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis; 2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory; 3. Other difficult clinical problems where…
Read the full statement (157 words)
Total or hemi-shoulder replacement is indicated for:
1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).
Hemi-shoulder replacement is also indicated for:
1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.
Only the titanium alloy humeral stem components and the cobalt-chrome alloy humeral stem components, which are marketed under either the Global Shoulder or Global Advantage Shoulder name, are intended for press-fit or cemented fixation. The glenoid components are for cemented use only.
CAUTION:
The cobalt-chrome alloy humeral components, which are marketed under the HRP Shoulder name and all glenoid components are for CEMENTED USE ONLY.
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/K992065 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992065: Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992065
Report an extraction error
Are you the manufacturer?
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