510(k) · Cleared
ClearedDepuy Global Cap HA Resurfacing Shoulder Humeral Heads
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 3, 2003 as substantially equivalent to K031971 (DePuy Orthopaedics, Inc., 2003) after a 26-day review. Its family tree reaches back 5 generations to 1980. 135 later devices descend from it.
- Decided
- Dec 3, 2003
- Review
- 26 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K800494 (1980). 9 ancestors in all. 135 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK800494 New Jersey Hemiarthroplasty Sholder ProsDepuy, Inc. · 1980
- 4 generations backK991585 Bipolar Shoulder ProsthesisBiomet, Inc. · 1999
- 3 generations backK002998 Biomet BI-Polar Shoulder SystemBiomet, Inc. · 2000 · Recalled
- 2 generations backK010827 Copeland MB/HA Resurfacing Humeral HeadsBiomet Orthopedics, Inc. · 2001 · Recalled
- 1 generation backK031971 Global Cap Resurfacing Replacement ShoulderDePuy Orthopaedics, Inc. · 2003
- This deviceK033516 Depuy Global Cap HA Resurfacing Shoulder Humeral HeadsDePuy Orthopaedics, Inc. · 2003
- Descendant · cites it directly · 121 of its ownK061862 Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006
- Descendant · 2 generations on · 120 of its ownK071147 Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007
- Descendant · 3 generations on · 110 of its ownK102924 Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011
- Descendant · 4 generations on · 108 of its ownK110599 Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011
- Descendant · 3 generations on · 105 of its ownK113413 Ascend Shoulder SystemTornier, Inc. · 2012
Showing 5 of 135 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 135 · See all- K061862Axiom Orthopaedics Shoulder Resurfacing SystemAxiom Orthopaedics, Inc. · 2006 · cites it directly121descendants
- K071147Nexa Orthopedics Total Shoulder SystemNexa Orthopedics, Inc. · 2007 · 2 generations on120descendants
- K102924Aequalis Ascend Modular Anatomic Shoulder SystemTornier, Inc. · 2011 · 3 generations on110descendants
- K110599Aequalis Ascend Modular Reverse Shoulder SystemTornier, Inc. · 2011 · 4 generations on108descendants
- K113413Ascend Shoulder SystemTornier, Inc. · 2012 · 3 generations on105descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K800494 | New Jersey Hemiarthroplasty Sholder Pros | Depuy, Inc. | 1980 | — |
| −4 | K991585 | Bipolar Shoulder Prosthesis | Biomet, Inc. | 1999 | — |
| −3 | K002998 | Biomet BI-Polar Shoulder System | Biomet, Inc. | 2000 | 1 |
| −2 | K010827 | Copeland MB/HA Resurfacing Humeral Heads | Biomet Orthopedics, Inc. | 2001 | 1 |
| −1 | K031971 | Global Cap Resurfacing Replacement Shoulder | DePuy Orthopaedics, Inc. | 2003 | — |
| 0 (this device) | K033516 | Depuy Global Cap HA Resurfacing Shoulder Humeral Heads | DePuy Orthopaedics, Inc. | 2003 | — |
| +1 | K061862 | Axiom Orthopaedics Shoulder Resurfacing System | Axiom Orthopaedics, Inc. | 2006 | — |
| +2 | K071147 | Nexa Orthopedics Total Shoulder System | Nexa Orthopedics, Inc. | 2007 | — |
| +3 | K102924 | Aequalis Ascend Modular Anatomic Shoulder System | Tornier, Inc. | 2011 | — |
| +4 | K110599 | Aequalis Ascend Modular Reverse Shoulder System | Tornier, Inc. | 2011 | — |
| +3 | K113413 | Ascend Shoulder System | Tornier, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1991 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 4 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 5 | 0 |
| 2018 | 8 | 0 |
| 2019 | 10 | 0 |
| 2020 | 11 | 0 |
| 2021 | 11 | 0 |
| 2022 | 16 | 0 |
| 2023 | 11 | 0 |
| 2024 | 10 | 0 |
| 2025 | 12 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K031971 | Global Cap Resurfacing Replacement ShoulderSummary page 1…STANTIALLY EQUIVALENT DEVICES: Humneral Head: DePuy Global CAP Resurfacing Replacement Shoulder, K03 1971 DEVICE DESCRIPTION: The DePuy Global CAP Tm HA Resurfacing Shoulder Humeral Heads are composed of a cobalt chrome molybdenum al… | 2003 |
| † | K001277 | Triflange Acetabular Cup System | 2000 |
What descends from it? (135)
See all 1354 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 23 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K061862 (Axiom Orthopaedics, Inc., 2006) has gone furthest, with 121 descendants of its own.
- 8 other devices also cite its predicate K031971.
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.
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 DePuy Global CAPTM HA Resurfacing Shoulder Humeral Heads are intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation. The DePuy Global CAPTM HA Resurfacing Shoulder Humeral…
Read the full statement (124 words)
The DePuy Global CAPTM HA Resurfacing Shoulder Humeral Heads are intended as a hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and the rotator cuff is intact or reconstructable. This device is designed to increase shoulder mobility by: reducing pain; restoring alignment; restoring flexion and extension movement; and resisting dislocation.
The DePuy Global CAPTM HA Resurfacing Shoulder Humeral Heads are indicated for use as a replacement of shoulder joints disabled by rheumatoid arthritis with pain, non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis), deformity and/or limited motion, fractures of the humeral head and traumatic arthritis.
CAUTION: The DePuy Global CAP T I HA Resurfacing Shoulder Humeral Heads are intended for cementless use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033516 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033516: Depuy Global Cap HA Resurfacing Shoulder Humeral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033516
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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