510(k) · Cleared
ClearedDELTA XTEND Reverse 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 Jul 22, 2021 as substantially equivalent to K120174 (Depuy France, 2012) and 3 other predicates after a 216-day review. Its family tree reaches back 13 generations to 1991. 1 of the 77 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 22, 2021
- Review
- 216 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K911686 (1991). 76 ancestors in all, the oldest K790987 (1979). No later device cites it as a predicate yet. 1 of the 77 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 9 generations between
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
- 1 generation backK192855 DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020
- This deviceK203694 DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC · 2021
Show all 13 generations
- Root · 13 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 12 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 11 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 10 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 9 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 6 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 5 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 4 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 3 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 2 generations backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
- 1 generation backK192855 DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020
- This deviceK203694 DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC · 2021
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −12 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −9 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −6 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −5 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −4 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −3 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −2 | K120174 | Deput Delta Xtend Reverse Shoulder | Depuy France | 2012 | 2 |
| −1 | K192855 | DELTA XTEND (TM) Reverse Shoulder System | Depuy (Ireland) | 2020 | — |
| 0 (this device) | K203694 | DELTA XTEND Reverse Shoulder System | Depuy Ireland UC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1987 | 3 | 0 |
| 1989 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K120174 | Deput Delta Xtend Reverse ShoulderSummary page 4…660 Product Code(s) PHX, KWS Legally Marketed Device(s) Predicate Devices: DePuy Synthes DELTA XTEND Reverse Shoulder to Which Equivalence is System (K120174, K192855) and Tornier Aequalis PerFORM Reversed Claimed and Aequalis PerFORM+ Reversed Glenoid Shoulder Pros… | 2012 |
| * | K192855 | DELTA XTEND (TM) Reverse Shoulder SystemSummary page 4…ct Code(s) PHX, KWS Legally Marketed Device(s) Predicate Devices: DePuy Synthes DELTA XTEND Reverse Shoulder to Which Equivalence is System (K120174, K192855) and Tornier Aequalis PerFORM Reversed Claimed and Aequalis PerFORM+ Reversed Glenoid Shoulder Prosthesis… | 2020 |
| * | K161742 | Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidSummary page 4…174, K192855) and Tornier Aequalis PerFORM Reversed Claimed and Aequalis PerFORM+ Reversed Glenoid Shoulder Prosthesis (K161742, K183696) Reference Device: DePuy Synthes GLOBAL UNITE Platform Shoulder… | 2016 |
| * | K183696 | Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidSummary page 4…855) and Tornier Aequalis PerFORM Reversed Claimed and Aequalis PerFORM+ Reversed Glenoid Shoulder Prosthesis (K161742, K183696) Reference Device: DePuy Synthes GLOBAL UNITE Platform Shoulder System… | 2019 |
| † | K170748 | GLOBAL UNITE Platform Shoulder System | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 9 companies; a new generation was cleared every 1.0 years on median.
- 25 of the 76 ancestors have a recall of any class; 1 has a Class I recall.
- 7 other devices also cite its predicate K120174.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 DePuy Synthes DELTA XTEND™ Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with: • severe arthropathy and/or; • a previous failed joint replacement and/or; • 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 The patient’s…
Read the full statement (211 words)
The DePuy Synthes DELTA XTEND™ Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
• a previous failed joint replacement and/or;
• 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
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.
DELTA XTEND™ Hemi-Shoulder Replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the revision of a previously failed DELTA XTEND™ Reverse Shoulder. Porous-coated epiphysis are indicated for use in total shoulder replacement only.
The metaglene component is either HA coated or porous-coated and is intended for cementless use with the addition of screws for fixation. Central screws can only be used with the porous-coated metaglenes and are required to be used with porous-coating augmented metaglenes.
The modular humeral stem is HA coated and is intended for cementless use. The HA coated humeral epiphysis is intended for cementless use. The porous-coated epiphysis is intended for cemented or cementless use.
All other metallic components are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203694 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203694: DELTA XTEND Reverse 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/K203694
Report an extraction error
Are you the manufacturer?
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