510(k) · Cleared
Recalled · Class II · 2021Depuy Global Unite Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy (Ireland) · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Dec 15, 2010 as substantially equivalent to K063652 (DePuy Orthopaedics, Inc., 2007) and 2 other predicates after a 153-day review. Its family tree reaches back 7 generations to 1991. 16 later devices descend from it. It has been recalled 8 times.
- Decided
- Dec 15, 2010
- Review
- 153 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 8
- Predicates
- 3
Its longest line of descent runs back 7 generations to K911686 (1991). 21 ancestors in all, the oldest K800494 (1980). 16 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 4 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 3 generations backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- 2 generations backK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- 1 generation backK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
- This deviceK101996 Depuy Global Unite Shoulder SystemDepuy (Ireland) · 2010
- Descendant · cites it directly · 10 of its ownK170748 GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC · 2018 · Recalled
- Descendant · cites it directly · 8 of its ownK170910 Medacta Anatomic Shoulder ProsthesisMedacta International S.A. · 2017 · Recalled
- Descendant · 2 generations on · 3 of its ownK191433 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
- Descendant · 2 generations on · 3 of its ownK192855 DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020
- Descendant · 2 generations on · 3 of its ownK180089 Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A. · 2018
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K170748GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC · 2018 · cites it directly10descendants
- K170910Medacta Anatomic Shoulder ProsthesisMedacta International S.A. · 2017 · cites it directly8descendants
- K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020 · 2 generations on3descendants
- K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020 · 2 generations on3descendants
- K180089Medacta Shoulder System Short Humeral DiaphysisMedacta International S.A. · 2018 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −6 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −3 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| −2 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| −1 | K071379 | Delta Xtend Reverse Shoulder Modular Stem | DePuy Orthopaedics, Inc. | 2007 | — |
| 0 (this device) | K101996 | Depuy Global Unite Shoulder System | Depuy (Ireland) | 2010 | — |
| +1 | K170748 | GLOBAL UNITE Platform Shoulder System | Depuy Ireland UC | 2018 | 8 |
| +1 | K170910 | Medacta Anatomic Shoulder Prosthesis | Medacta International S.A. | 2017 | 1 |
| +2 | K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020 | — |
| +2 | K192855 | DELTA XTEND (TM) Reverse Shoulder System | Depuy (Ireland) | 2020 | — |
| +2 | K180089 | Medacta Shoulder System Short Humeral Diaphysis | Medacta International S.A. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 4 | 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 PHX? 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 PHX device
- #1 K212737 INHANCE™ Reverse Shoulder Systemscore 28.4 · 15 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 |
|---|---|---|---|
| * | K063652 | Global AP Porous Coated Humeral StemSummary page 4…olymer Cemented HSD: Prosthesis, Shoulder, Hemi-, humeral Metallic Uncemented MBEF: Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Uncemented DePuy Global AP, K063652 (stem) and K060874 (head) " DePuy Delta Xtend, K071379 Kio199¢ P 22 DEVICE DESCRIPTION: - The Global UNITE Shou… | 2007 |
| * | K060874 | Depuy Global AP Shoulder SystemSummary page 4…D: Prosthesis, Shoulder, Hemi-, humeral Metallic Uncemented MBEF: Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Uncemented DePuy Global AP, K063652 (stem) and K060874 (head) " DePuy Delta Xtend, K071379 Kio199¢ P 22 DEVICE DESCRIPTION: - The Global UNITE Shoulder System include… | 2006 |
| * | K071379 | Delta Xtend Reverse Shoulder Modular StemSummary page 4…ral Metallic Uncemented MBEF: Prosthesis, Shoulder, Semi-constrained, Metal/Polymer, Uncemented DePuy Global AP, K063652 (stem) and K060874 (head) " DePuy Delta Xtend, K071379 Kio199¢ P 22 DEVICE DESCRIPTION: - The Global UNITE Shoulder System includes a two-piece stem design that pr{)v… | 2007 |
What descends from it? (16)
See all 164 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 7, 2021 | Class II | Z-0484-2022 | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage |
| Dec 7, 2021 | Class II | Z-0485-2022 | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage |
| Dec 7, 2021 | Class II | Z-0486-2022 | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage |
| Dec 7, 2021 | Class II | Z-0487-2022 | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage |
| Dec 7, 2021 | Class II | Z-0490-2022 | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage |
| Dec 7, 2021 | Class II | Z-0483-2022 | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage |
| Dec 7, 2021 | Class II | Z-0488-2022 | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage |
| Dec 7, 2021 | Class II | Z-0489-2022 | Equipment maintenance | Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage |
The 5 latest of 8 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
- 4 of the 21 ancestors have a recall of any class.
- Of its descendants, K170748 (Depuy Ireland UC, 2018) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K063652.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · PHX
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PHX
72in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PHX
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PHX
2,848in 2025
MAUDE reports naming product code PHX, 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 | 5 | 97 | 0 | 0 |
| 2008 | 6 | 79 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 8 | 124 | 0 | 0 |
| 2011 | 12 | 94 | 0 | 0 |
| 2012 | 12 | 114 | 0 | 0 |
| 2013 | 8 | 143 | 0 | 0 |
| 2014 | 12 | 110 | 0 | 0 |
| 2015 | 4 | 206 | 2 | 14 |
| 2016 | 4 | 132 | 0 | 5 |
| 2017 | 11 | 141 | 0 | 25 |
| 2018 | 14 | 127 | 1 | 323 |
| 2019 | 9 | 144 | 3 | 504 |
| 2020 | 13 | 143 | 3 | 986 |
| 2021 | 21 | 143 | 8 | 1,404 |
| 2022 | 9 | 198 | 0 | 1,342 |
| 2023 | 9 | 154 | 7 | 1,401 |
| 2024 | 9 | 139 | 1 | 2,142 |
| 2025 | 9 | 72 | 3 | 2,848 |
| 2026 | 18 | 130 | 7 | — |
What is it indicated for?
The Global UNITE humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following: 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…
Read the full statement (245 words)
The Global UNITE humeral stems, suture collars, epiphyseal components and humeral heads are intended for cemented or uncemented total shoulder or hemi-shoulder replacement in treatment of the following:
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. Deformity and/or limited motion
When used in a total shoulder replacement, the Global UNITE implants are to be used with DePuy glenoids. The glenoids are for cemented use only.
When well-fixed, the Global UNITE humeral stems, in conjunction with existing Delta Xtend epiphyseal components, are also indicated for conversion to a reverse, in treatment of a grossly deficient rotator cuff joint with severe arthropathy or a previously failed joint replacement with a grossly deficient rotator cuff joint. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary. The Delta Xtend metaglene component is HA-coated and is intended for uncemented use with the addition of screws for fixation. The Delta Xtend epiphyseal components are HA-coated and are intended for uncemented use.
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/K101996 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101996: Depuy Global Unite Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101996
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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