510(k) · Cleared
Recalled · Class II · 2021GLOBAL UNITE Platform Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ireland UC · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Jan 11, 2018 as substantially equivalent to K052906 (Zimmer, Inc., 2005) and 3 other predicates after a 307-day review. Its family tree reaches back 8 generations to 1991. 10 later devices descend from it. It has been recalled 8 times.
- Decided
- Jan 11, 2018
- Review
- 307 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 8
- Predicates
- 4
Its longest line of descent runs back 8 generations to K911686 (1991). 41 ancestors in all, the oldest K790987 (1979). 10 later devices descend from it, 5 citing it directly.
- Root · 8 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 6 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 5 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 4 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 3 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 1 generation backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- This deviceK170748 GLOBAL UNITE Platform Shoulder SystemDepuy Ireland UC · 2018
- Descendant · cites it directly · 3 of its ownK191433 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020
- Descendant · cites it directly · 3 of its ownK192855 DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020
- Descendant · 2 generations on · 2 of its ownK231657 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2024
- Descendant · 2 generations on · 1 of its ownK241944 AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2025
- Descendant · cites it directly · 1 of its ownK202098 GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K191433AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2020 · cites it directly3descendants
- K192855DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020 · cites it directly3descendants
- K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2024 · 2 generations on2descendants
- K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbH · 2025 · 2 generations on1descendant
- K202098GLOBAL UNITE™ Platform Shoulder SystemDepuy Ireland UC · 2020 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −7 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −6 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −4 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −3 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −1 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| 0 (this device) | K170748 | GLOBAL UNITE Platform Shoulder System | Depuy Ireland UC | 2018 | — |
| +1 | K191433 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2020 | — |
| +1 | K192855 | DELTA XTEND (TM) Reverse Shoulder System | Depuy (Ireland) | 2020 | — |
| +2 | K231657 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2024 | — |
| +2 | K241944 | AGILON® XO Shoulder Replacement System | Implantcast GmbH | 2025 | — |
| +1 | K202098 | GLOBAL UNITE™ Platform Shoulder System | Depuy Ireland UC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K052906 | Zimmer Trabecular Metal Reverse Shoulder SystemSummary page 5…21 CFR 888.3660; 21 CFR 888.3690 Product Code(s) PHX; KWS; HSD Legally marketed device(s) to Zimmer Trabecular Metal® Reverse Shoulder System, K052906; which equivalence is claimed Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 1… | 2005 |
| * | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMSummary page 5…l® Reverse Shoulder System, K052906; which equivalence is claimed Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm, K060704 DePuy GLOBAL UNITE Shoulder System, K101996 DePuy GLOBAL UNITE Sh… | 2006 |
| * | K101996 | Depuy Global Unite Shoulder SystemSummary page 5…Trabecular Metal Reverse Shoulder System, Sizes 8mm and 10mm, K060704 DePuy GLOBAL UNITE Shoulder System, K101996 DePuy GLOBAL UNITE Shoulder System, K133834 Reason for 510(k) submission This 510(k) submissio… | 2010 |
| * | K133834 | Depuy Global Unite Shoulder SystemSummary page 5…10mm, K060704 DePuy GLOBAL UNITE Shoulder System, K101996 DePuy GLOBAL UNITE Shoulder System, K133834 Reason for 510(k) submission This 510(k) submission is to add the GLOBAL UNITE Reverse Fracture… | 2014 |
What descends from it? (10)
5 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 27 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 41 ancestors have a recall of any class.
- Of its descendants, K191433 (Implantcast GmbH, 2020) has gone furthest, with 3 descendants of its own.
- 12 other devices also cite its predicate K052906.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Platform Shoulder System is intended for cemented or uncemented total or hemi-shoulder arthroplasty in treatment of the following: • A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or • rheumatoid arthritis • Fracture 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…
Read the full statement (476 words)
The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemented total or hemi-shoulder arthroplasty in treatment of the following:
• A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or
• rheumatoid arthritis
• Fracture 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
• Irreducible 3- and 4-part fractures of the proximal humerus
• Ununited humeral head fractures
• Avascular necrosis of the humeral head
• Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of a failed primary component)
Hemi-shoulder arthroplasty is also indicated for:
• Deformity and/or limited motion
The GLOBAL UNITE Reverse Fracture Epiphyseal Component, in conjunction with components from the existing DELTA XTEND™ Reverse Shoulder System and GLOBAL UNITE Platform Shoulder System, is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient’s joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. It is intended for cemented or uncemented reverse shoulder arthroplasty in treatment of the following:
• Fracture 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
• Irreducible 3- and 4-part fractures of the proximal humerus
• Ununited humeral head fractures
The GLOBAL UNITE Reverse Fracture Epiphyseal Component is only intended for use in the treatment of proximal humeral fractures. Bone preparation instrumentation has not been validated to accommodate its use in a non-fracture press-fit application.
GLOBAL UNITE Humeral Stems, in conjunction with existing DELTA XTEND Epiphyseal Components, are indicated for use in reverse shoulder arthroplasty 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 reverse implant(s), and a functional deltoid muscle is necessary to use the device.
When used in a total shoulder arthroplasty, the GLOBAL UNITE Implants are to be used with DePuy glenoid components. The glenoid components are for cemented use only. GLOBAL UNITE Humeral Implants are for cemented or uncemented use.
When used in a reverse shoulder arthroplasty, the GLOBAL UNITE and DELTA XTEND Humeral Implants are to be used with the HA-coated DELTA XTEND Metaglene Devices. The metaglene implants are intended for uncemented use only with additional screw fixation. The HA-coated DELTA XTEND Humeral Implants are intended for uncemented use only. GLOBAL UNITE humeral implants are for cemented or uncemented use. The DELTA XTEND epiphyseal components are HA-coated and are intended for uncemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170748: GLOBAL UNITE Platform 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/K170748
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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