510(k) · Cleared
ClearedDepuy Global Shoulder Glenoid
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 13, 1998 after a 77-day review. The FDA summary names its predicate without a number. 1 of the 336 devices in its family, counting itself, has a Class I recall. 335 later devices descend from it.
- Decided
- Jul 13, 1998
- Review
- 77 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 0
335 later devices descend from it, 12 citing it directly. 1 of the 336 devices in this family, counting this one, has a Class I recall.
- This deviceK981487 Depuy Global Shoulder GlenoidDePuy Orthopaedics, Inc. · 1998
- Descendant · cites it directly · 253 of its ownK030710 Bio-Modular Shoulder SystemBiomet, Inc. · 2003 · Recalled
- Descendant · 2 generations on · 176 of its ownK043100 Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid…Biomet, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 175 of its ownK072804 Comprehensive RS Shoulder SystemBiomet Manufacturing Corp · 2007
- Descendant · 3 generations on · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- Descendant · cites it directly · 158 of its ownK052472 Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005
Showing 5 of 335 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 335 · 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
- K052472Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005 · cites it directly158descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981487 | Depuy Global Shoulder Glenoid | DePuy Orthopaedics, Inc. | 1998 | — |
| +1 | K030710 | Bio-Modular Shoulder System | Biomet, Inc. | 2003 | 1 |
| +2 | K043100 | Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components | Biomet, Inc. | 2005 | 1 |
| +2 | K072804 | Comprehensive RS Shoulder System | Biomet Manufacturing Corp | 2007 | — |
| +3 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| +1 | K052472 | Depuy Global Shoulder Crosslink Glenoid | DePuy Orthopaedics, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 1 |
| 2009 | 2 | 0 |
| 2010 | 7 | 0 |
| 2011 | 12 | 0 |
| 2012 | 14 | 0 |
| 2013 | 14 | 0 |
| 2014 | 11 | 0 |
| 2015 | 15 | 0 |
| 2016 | 14 | 0 |
| 2017 | 18 | 0 |
| 2018 | 18 | 0 |
| 2019 | 22 | 0 |
| 2020 | 22 | 0 |
| 2021 | 29 | 0 |
| 2022 | 22 | 0 |
| 2023 | 23 | 0 |
| 2024 | 20 | 0 |
| 2025 | 26 | 0 |
| 2026 | 26 | 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? (2)
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 System Named without a submission number | |
| * | — | Global Total Shoulder with DuPont Enhanced UHMWPe Named without a submission number |
What descends from it? (335)
See all 33512 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K030710 | Bio-Modular Shoulder System | 2003 | 253 |
| K052472 | Depuy Global Shoulder Crosslink Glenoid | 2005 | 158 |
| K042021 | Exactech Equinoxe Shoulder System | 2004 | 71 |
| K060694 | Modular Hybrid Glenoid | 2006 | 57 |
| K123122 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris) | 2013 | 56 |
| K093430 | Exactech Equinoxe XL Keeled Glenoid, Pegged Glenoid, Exactech Equinoxe Cage, Glenoid… | 2010 | 24 |
| K091196 | GRS Glenoid Resurfacing System | 2009 | 23 |
| K152825 | Catalyst CSR Shoulder System | 2016 | 7 |
| K173812 | Catalyst CSR 3 Peg Glenoids | 2018 | 1 |
| K203230 | Global Shoulder and Delta CTA systems | 2021 | 0 |
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 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 DePuy Global Shoulder Glenoid is intended for use as a cemented glenoid component in total shoulder arthroplasty completed using humeral components of the DePuy Global Total Shoulder System. The humeral components of the Global Total Shoulder System are intended for cemented or cementless use as a total or hemi-shoulder replacement which is indicated for: 1. A severely painful and/or a severely disabled joint resulting from osteoarthritis, traumatic…
Read the full statement (160 words)
The DePuy Global Shoulder Glenoid is intended for use as a cemented glenoid component in total shoulder arthroplasty completed using humeral components of the DePuy Global Total Shoulder System.
The humeral components of the Global Total Shoulder System are intended for cemented or cementless use as a total or hemi-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 System 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/K981487 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981487: Depuy Global Shoulder Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981487
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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