510(k) · Cleared
ClearedDepuy Global AP Cta Humeral Head
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on Dec 18, 2008 as substantially equivalent to K000575 (DePuy Orthopaedics, Inc., 2000) after a 92-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Dec 18, 2008
- Review
- 92 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000575 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK000575 Global Advantage Extended Humeral HeadDePuy Orthopaedics, Inc. · 2000
- This deviceK082715 Depuy Global AP Cta Humeral HeadDePuy Orthopaedics, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK203230 Global Shoulder and Delta CTA systemsDepuy Lnc. · 2021
- Descendant · cites it directly · 0 of its ownK110706 Exactech Equinoxe Cuff Tear Arthroplasty (Cta) HeadExactech, Inc. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000575 | Global Advantage Extended Humeral Head | DePuy Orthopaedics, Inc. | 2000 | — |
| 0 (this device) | K082715 | Depuy Global AP Cta Humeral Head | DePuy Orthopaedics, Inc. | 2008 | — |
| +1 | K203230 | Global Shoulder and Delta CTA systems | Depuy Lnc. | 2021 | — |
| +1 | K110706 | Exactech Equinoxe Cuff Tear Arthroplasty (Cta) Head | Exactech, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2021 | 1 | 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (1)
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 |
|---|---|---|---|
| * | K000575 | Global Advantage Extended Humeral HeadSummary page 1…Metallic Uncemented SUBSTANTIALLY EQUIVALENT DePuy Global Advantage Extended Head, DEVICE: K000575 DEVICE DESCRIPTION: The Global AP CTA Humeral Head, in combination with a Global AP Shoulder humeral stem, is intended for use i… | 2000 |
What descends from it? (2)
2 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?
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Global AP CTA Humeral Head, used with a Global AP Humeral Stem, is indicated for use in hemi-shoulder replacement. 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…
Read the full statement (144 words)
The Global AP CTA Humeral Head, used with a Global AP Humeral Stem, is indicated for use in hemi-shoulder replacement.
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.
3. Rotator cuff tear arthropathy.
4. Deformity and/or limited motion.
Un-coated Global AP Humeral Stems are indicated for cemented use only. Global AP Humeral Stems with Porocoat® are indicated for cemented or cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082715 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082715: Depuy Global AP Cta Humeral Head.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082715
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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