510(k) · Cleared
ClearedGlobal AP Porous Coated Humeral Stem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Cleared on Feb 1, 2007 as substantially equivalent to K060874 (DePuy Orthopaedics, Inc., 2006) and 1 other predicate after a 55-day review. Its family tree reaches back 4 generations to 1991. 18 later devices descend from it.
- Decided
- Feb 1, 2007
- Review
- 55 days
- Class
- Class II
- Product code
- MBF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K911686 (1991). 11 ancestors in all. 18 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 3 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 2 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 1 generation backK060874 Depuy Global AP Shoulder SystemDePuy Orthopaedics, Inc. · 2006
- This deviceK063652 Global AP Porous Coated Humeral StemDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 16 of its ownK101996 Depuy Global Unite Shoulder SystemDepuy (Ireland) · 2010 · Recalled
- Descendant · 2 generations on · 10 of its ownK170748 GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC · 2018 · Recalled
- Descendant · 2 generations on · 8 of its ownK170910 Medacta Anatomic Shoulder ProsthesisMedacta International S.A. · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK191433 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
- Descendant · 3 generations on · 3 of its ownK192855 DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K101996Depuy Global Unite Shoulder SystemDepuy (Ireland) · 2010 · cites it directly16descendants
- K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC · 2018 · 2 generations on10descendants
- K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A. · 2017 · 2 generations on8descendants
- K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020 · 3 generations on3descendants
- K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −3 | 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 | — |
| −1 | K060874 | Depuy Global AP Shoulder System | DePuy Orthopaedics, Inc. | 2006 | — |
| 0 (this device) | K063652 | Global AP Porous Coated Humeral Stem | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K101996 | Depuy Global Unite Shoulder System | Depuy (Ireland) | 2010 | 8 |
| +2 | K170748 | GLOBAL UNITE Platform Shoulder System | Depuy Ireland UC | 2018 | 8 |
| +2 | K170910 | Medacta Anatomic Shoulder Prosthesis | Medacta International S.A. | 2017 | 1 |
| +3 | K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020 | — |
| +3 | K192855 | DELTA XTEND (TM) Reverse Shoulder System | Depuy (Ireland) | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 4 | 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 MBF? 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 MBF device
- #1 K202716 Ignite Anatomic Shoulder Systemscore 20.3 · 14 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 |
|---|---|---|---|
| * | K060874 | Depuy Global AP Shoulder SystemSummary page 1…s DEVICE PRODUCT CODE: 87 MBF 87 KWS SUBSTANTIALLY EQUIVALENT DePuy Global APTM Shoulder System, K060874 DEVICE: Global® Advantage Shoulder Humeral Stem with Poroco… | 2006 |
| * | K011047 | Global Advantage Humeral Stem with Porocoat Our reading of the summary gave K001047, FDA’s number for Guthrie Latex Surgical Glove (Pre-Powdered) (Guthrie Medicare Products (Melaka) Sdn Bhd). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Global® Advantage Shoulder Humeral Stem with Porocoat®”. | 2001 |
What descends from it? (18)
See all 182 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 2 companies; a new generation was cleared every 7.0 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K101996 (Depuy (Ireland), 2010) has gone furthest, with 16 descendants of its own.
- 6 other devices also cite its predicate K060874.
How does its category compare?
All MBF devicesMBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MBF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBF
144in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBF
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBF
255in 2025
MAUDE reports naming product code MBF, 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 | — | 0 | 2 |
| 2008 | 1 | — | 0 | 7 |
| 2009 | 1 | — | 1 | 16 |
| 2010 | 0 | — | 0 | 24 |
| 2011 | 0 | — | 0 | 32 |
| 2012 | 2 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 40 |
| 2014 | 1 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 49 |
| 2016 | 0 | — | 0 | 85 |
| 2017 | 2 | — | 1 | 193 |
| 2018 | 1 | — | 1 | 99 |
| 2019 | 2 | — | 2 | 47 |
| 2020 | 2 | — | 0 | 24 |
| 2021 | 1 | — | 0 | 36 |
| 2022 | 4 | 164 | 8 | 114 |
| 2023 | 4 | 144 | 1 | 143 |
| 2024 | 2 | — | 0 | 164 |
| 2025 | 2 | — | 0 | 255 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Total Shoulder 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…
Read the full statement (162 words)
Total Shoulder 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).
The humeral components of the Global APTM Shoulder are intended for cemented or cementless use as a total or hemi-shoulder replacement.
Global APTM Porous Coated Humeral Stems are intended for cemented or cementless use, with fixation provided by biological tissue ingrowth into the porous coating.
Glenoid components of the Global APTM Shoulder are indicated only for use with bone cement for the above indications.
Hemi-shoulder replacement is also indicated for:
1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.
3. Deformity and/or limited motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063652 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063652: Global AP Porous Coated Humeral Stem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063652
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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