510(k) · Cleared
ClearedGlobal Total Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Cleared on Jan 16, 1992 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 452 devices in its family, counting itself, has a Class I recall. 451 later devices descend from it.
- Decided
- Jan 16, 1992
- Review
- 90 days
- Class
- Class II
- Product code
- KWT
- Recalls
- None
- Predicates
- 0
451 later devices descend from it, 3 citing it directly. 1 of the 452 devices in this family, counting this one, has a Class I recall.
- This deviceK914695 Global Total ShoulderDepuy, Inc. · 1992
- Descendant · cites it directly · 425 of its ownK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- Descendant · 2 generations on · 405 of its ownK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- Descendant · 3 generations on · 338 of its ownK021478 Delta ShoulderDepuy, Inc. · 2003
- Descendant · 4 generations on · 295 of its ownK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- Descendant · 4 generations on · 280 of its ownK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
Showing 5 of 451 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 451 · 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 · 2 generations on405descendants
- K021478Delta ShoulderDepuy, Inc. · 2003 · 3 generations on338descendants
- K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006 · 4 generations on295descendants
- K030941Aequalis Reversed Shoulder ProsthesisTornier · 2004 · 4 generations on280descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K914695 | Global Total Shoulder | Depuy, Inc. | 1992 | — |
| +1 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| +2 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| +3 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| +4 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| +4 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 7 | 0 |
| 2006 | 14 | 0 |
| 2007 | 9 | 0 |
| 2008 | 11 | 1 |
| 2009 | 2 | 0 |
| 2010 | 11 | 0 |
| 2011 | 24 | 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), 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 KWT device
- #1 K231657 AGILON® XO Shoulder Replacement Systemscore 17.7 · 17 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (451)
See all 4513 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, K984541 (DePuy Orthopaedics, Inc., 1999) has gone furthest, with 425 descendants of its own.
How does its category compare?
All KWT devicesKWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWT
242in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWT
749in 2025
MAUDE reports naming product code KWT, 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 | 1 | — | 0 | 32 |
| 2008 | 0 | — | 1 | 48 |
| 2009 | 0 | — | 0 | 58 |
| 2010 | 1 | — | 7 | 71 |
| 2011 | 5 | 165 | 0 | 112 |
| 2012 | 1 | — | 2 | 83 |
| 2013 | 1 | — | 1 | 113 |
| 2014 | 1 | — | 0 | 168 |
| 2015 | 2 | — | 0 | 176 |
| 2016 | 2 | — | 1 | 445 |
| 2017 | 1 | — | 1 | 560 |
| 2018 | 2 | — | 1 | 480 |
| 2019 | 4 | 91 | 3 | 419 |
| 2020 | 1 | — | 0 | 215 |
| 2021 | 1 | — | 0 | 228 |
| 2022 | 1 | — | 0 | 273 |
| 2023 | 1 | — | 1 | 361 |
| 2024 | 1 | — | 0 | 601 |
| 2025 | 4 | 242 | 0 | 749 |
| 2026 | 1 | — | 0 | — |
https://510kreport.com/device/K914695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K914695: Global Total Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K914695
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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