510(k) · Cleared
Recalled · 2008Delta Xtend Reverse Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Feb 2, 2007 as substantially equivalent to K021478 (Depuy, Inc., 2003) and 3 other predicates after a 184-day review. Its family tree reaches back 5 generations to 1991. 250 later devices descend from it. It has been recalled 8 times.
- Decided
- Feb 2, 2007
- Review
- 184 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 8
- Predicates
- 4
Its longest line of descent runs back 5 generations to K911686 (1991). 12 ancestors in all, the oldest K800494 (1980). 250 later devices descend from it, 17 citing it directly.
- Root · 5 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 4 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 3 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 2 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 1 generation backK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- This deviceK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 191 of its ownK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 164 of its ownK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- Descendant · cites it directly · 161 of its ownK073676 Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008
- Descendant · 2 generations on · 159 of its ownK091751 Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009
- Descendant · cites it directly · 147 of its ownK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
Showing 5 of 250 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 250 · See all- K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007 · cites it directly191descendants
- K082120Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008 · cites it directly164descendants
- K073676Depuy Delta Xtend Reverse Shoulder High Mobility CupDePuy Orthopaedics, Inc. · 2008 · cites it directly161descendants
- K091751Depuy Delta Xtend Reverse Shoulder XLK CupDePuy Orthopaedics, Inc. · 2009 · 2 generations on159descendants
- K100142Aequalis Reversed Shoulder ProsthesisTornier · 2010 · cites it directly147descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −4 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −3 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −1 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| 0 (this device) | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K071379 | Delta Xtend Reverse Shoulder Modular Stem | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| +1 | K073676 | Depuy Delta Xtend Reverse Shoulder High Mobility Cup | DePuy Orthopaedics, Inc. | 2008 | — |
| +2 | K091751 | Depuy Delta Xtend Reverse Shoulder XLK Cup | DePuy Orthopaedics, Inc. | 2009 | — |
| +1 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 10 | 0 |
| 2014 | 12 | 0 |
| 2015 | 10 | 0 |
| 2016 | 10 | 0 |
| 2017 | 16 | 0 |
| 2018 | 13 | 0 |
| 2019 | 18 | 0 |
| 2020 | 19 | 0 |
| 2021 | 26 | 0 |
| 2022 | 20 | 0 |
| 2023 | 21 | 0 |
| 2024 | 15 | 0 |
| 2025 | 21 | 0 |
| 2026 | 21 | 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 |
|---|---|---|---|
| * | K021478 | Delta ShoulderSummary page 1…87 HSD SUBSTANTIALLY EQUIVALENT DePuy Delta CTA Reverse Shoulder System, DEVICE: K021478 DePuy Global Advantage Shoulder System,… | 2003 |
| * | K062116 | Delta Cta Reverse Shoulder System Humeral Heads Cleared while this submission was under review Summary page 2…T similarity in intended use, indications for use, materials and design to the DePuy Delta CTA Reverse Shoulder System (K021478), the DePuy Delta CTA Head (K062116), the DePuy Global Advantage Shoulder System (K992065), and the DePuy Global Advantage CTA Head (K000575, cleared as the DePuy Gl… | 2006 |
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 1…K021478 DePuy Global Advantage Shoulder System, K992065 DePuy Global Advantage CTA Head (cleared as… | 1999 |
| * | K000575 | Global Advantage Extended Humeral HeadSummary page 1…Advantage CTA Head (cleared as the DePuy Global Advantage Extended Head) K000575 DEVICE DESCRIPTION: The Delta XtendM Reverse Shoulder System is a modular shoulder prosthesis designed T f… | 2000 |
What descends from it? (250)
See all 25017 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071379 | Delta Xtend Reverse Shoulder Modular Stem | 2007 | 191 |
| K082120 | Aequalis Reversed Fracture Shoulder Prothesis | 2008 | 164 |
| K073676 | Depuy Delta Xtend Reverse Shoulder High Mobility Cup | 2008 | 161 |
| K100142 | Aequalis Reversed Shoulder Prosthesis | 2010 | 147 |
| K081620 | Modification to Depuy Delta Xtend Reverse Shoulder System | 2008 | 109 |
| K110599 | Aequalis Ascend Modular Reverse Shoulder System | 2011 | 108 |
| K123122 | Glenoid Intelligent Reusable Instrument System (Glenoid Iris) | 2013 | 56 |
| K120174 | Deput Delta Xtend Reverse Shoulder | 2012 | 41 |
| K112144 | Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis… | 2012 | 23 |
| K130895 | Reunion Rsa Shoulder System | 2013 | 14 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 10, 2008 | Not classified | Z-0536-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0537-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0539-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0538-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0532-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0533-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0534-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
| Jul 10, 2008 | Not classified | Z-0535-2009 | Device Design | Compressed air may become trapped between the cup and the stem, preventing the tapered walls from engaging and causing the cup to feel unstable. |
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 16 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 12 ancestors has a recall of any class.
- Of its descendants, K071379 (DePuy Orthopaedics, Inc., 2007) has gone furthest, with 191 descendants of its own.
- 18 other devices also cite its predicate K021478.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Delta Xtend TM Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement. Delta XtendTM Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous 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…
Read the full statement (146 words)
The Delta Xtend TM Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement.
Delta XtendTM Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous 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 to use the device.
In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.
Delta XtendTm hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively.
The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.
All other components are for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062250 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062250: Delta Xtend Reverse Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062250
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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