510(k) · Cleared
ClearedDepuy Global Shoulder Crosslink 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 Oct 6, 2005 as substantially equivalent to K981487 (DePuy Orthopaedics, Inc., 1998) and 2 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1994. 158 later devices descend from it.
- Decided
- Oct 6, 2005
- Review
- 28 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K943462 (1994). 8 ancestors in all, the oldest K914000 (1991). 158 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 2 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 1 generation backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- This deviceK052472 Depuy Global Shoulder Crosslink GlenoidDePuy Orthopaedics, Inc. · 2005
- Descendant · cites it directly · 75 of its ownK092122 Global Shoulder Steptech Anchor Peg GlenoidDePuy Orthopaedics, Inc. · 2009
- Descendant · cites it directly · 57 of its ownK060694 Modular Hybrid GlenoidBiomet Manufacturing Corp · 2006 · Recalled
- Descendant · 2 generations on · 56 of its ownK123122 Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic · 2013
- Descendant · cites it directly · 43 of its ownK103835 Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model…Howmedica Osteonics Corp. · 2011 · Recalled
- Descendant · 3 generations on · 39 of its ownK131129 Cas Psi ShoulderZimmer Cas · 2013
Showing 5 of 158 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 158 · See all- K092122Global Shoulder Steptech Anchor Peg GlenoidDePuy Orthopaedics, Inc. · 2009 · cites it directly75descendants
- K060694Modular Hybrid GlenoidBiomet Manufacturing Corp · 2006 · cites it directly57descendants
- K123122Glenoid Intelligent Reusable Instrument System (Glenoid Iris)Cleveland Clinic · 2013 · 2 generations on56descendants
- K103835Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C…Howmedica Osteonics Corp. · 2011 · cites it directly43descendants
- K131129Cas Psi ShoulderZimmer Cas · 2013 · 3 generations on39descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −2 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −1 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| 0 (this device) | K052472 | Depuy Global Shoulder Crosslink Glenoid | DePuy Orthopaedics, Inc. | 2005 | — |
| +1 | K092122 | Global Shoulder Steptech Anchor Peg Glenoid | DePuy Orthopaedics, Inc. | 2009 | — |
| +1 | K060694 | Modular Hybrid Glenoid | Biomet Manufacturing Corp | 2006 | 4 |
| +2 | K123122 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris) | Cleveland Clinic | 2013 | — |
| +1 | K103835 | Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX… | Howmedica Osteonics Corp. | 2011 | 1 |
| +3 | K131129 | Cas Psi Shoulder | Zimmer Cas | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 1 | 0 |
| 2015 | 7 | 0 |
| 2016 | 8 | 0 |
| 2017 | 8 | 0 |
| 2018 | 5 | 0 |
| 2019 | 11 | 0 |
| 2020 | 10 | 0 |
| 2021 | 13 | 0 |
| 2022 | 14 | 0 |
| 2023 | 16 | 0 |
| 2024 | 14 | 0 |
| 2025 | 17 | 0 |
| 2026 | 19 | 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.
Planning a device in KWS? 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 |
|---|---|---|---|
| * | K981487 | Depuy Global Shoulder Glenoid Our reading of the summary gave K981497, FDA’s number for Steritec Disposable Biological Test Pack-EO Gas (Steritec Products Mfg Co, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “DePuy Global Shoulder Glenoid”. | 1998 |
| * | K914000 | Global (TM) Total Shoulder W/Dupont Enhanced UhmwpeSummary page 2…IS OF SUBSTANTIAL EQUIVALENCE: The DePuy GlobalIM Crosslink Glenoids have the same design, intended use and indications as the Glenoid components cleared in K981497 and K914000 as part of DePuy's Global Shoulder System. The difference between the Crosslink Glenoids proposed in this submission and the Glen… | 1991 |
| * | K040166 | Depuy Sigma XLK Tibial InsertsSummary page 1…487 DCPLuy Global S;11oLItder-- K911000 DePay Sigma XLK Tibal Inserts - K040166 DEVICE DESCRIPTION: The DcPuy Global"' Crosslink( Glenoids are offered in an anchor peg and aI fin design. The Crosslink Glenoi… | 2004 |
What descends from it? (158)
See all 1587 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092122 | Global Shoulder Steptech Anchor Peg Glenoid | 2009 | 75 |
| K060694 | Modular Hybrid Glenoid | 2006 | 57 |
| K103835 | Reunion Tsa System-Humeral Press-Fit & Cemented Stems Model 5569-YY-20XX (YY=P,C… | 2011 | 43 |
| K130642 | SMR 3-Pegs Glenoids | 2013 | 14 |
| K202716 | Ignite Anatomic Shoulder System | 2021 | 13 |
| K203230 | Global Shoulder and Delta CTA systems | 2021 | 0 |
| K110905 | Total Shoulder System | 2011 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 1.6 years on median.
- 4 of the 8 ancestors have a recall of any class.
- Of its descendants, K092122 (DePuy Orthopaedics, Inc., 2009) has gone furthest, with 75 descendants of its own.
- 11 other devices also cite its predicate K981487.
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 Glenoid is intended for use in total shoulder replacement surgery for patients
suffering from:
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 communited, 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).
Glenoid components are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052472: Depuy Global Shoulder Crosslink Glenoid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052472
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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