510(k) · Cleared
ClearedDELTA XTEND (TM) Reverse 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 Feb 24, 2020 as substantially equivalent to K170748 (Depuy Ireland UC, 2018) and 2 other predicates after a 143-day review. Its family tree reaches back 12 generations to 1991. 1 of the 76 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Feb 24, 2020
- Review
- 143 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K911686 (1991). 72 ancestors in all, the oldest K790987 (1979). 3 later devices descend from it, 3 citing it directly. 1 of the 76 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations between
- 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 1 generation backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
- This deviceK192855 DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020
- Descendant · cites it directly · 0 of its ownK253624 INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2026
- Descendant · cites it directly · 0 of its ownK211553 Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK203694 DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC · 2021
Show all 12 generations
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 10 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 9 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 8 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 7 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK052906 Zimmer Trabecular Metal Reverse Shoulder SystemZimmer, Inc. · 2005 · Recalled
- 5 generations backK060704 Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MMZimmer, Inc. · 2006 · Recalled
- 4 generations backK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- 3 generations backK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- 2 generations backK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
- 1 generation backK120174 Deput Delta Xtend Reverse ShoulderDepuy France · 2012 · Recalled
- This deviceK192855 DELTA XTEND (TM) Reverse Shoulder SystemDepuy (Ireland) · 2020
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations back · 2008
Most influential descendants
Showing 3 of 3 · See all- K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2026 · cites it directly0descendants
- K211553Tecomet Global Unite Short Stem InstrumentationSymmetry Medical Manufacturing Inc. Dba Tecomet, Inc. · 2021 · cites it directly0descendants
- K203694DELTA XTEND Reverse Shoulder SystemDepuy Ireland UC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −11 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −10 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −8 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −7 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K052906 | Zimmer Trabecular Metal Reverse Shoulder System | Zimmer, Inc. | 2005 | 12 |
| −5 | K060704 | Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM | Zimmer, Inc. | 2006 | 10 |
| −4 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| −3 | K073688 | Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw | Exactech, Inc. | 2008 | 1 |
| −2 | K080642 | Comprehensive Reverse Shoulder | Biomet, Inc. | 2008 | Class I |
| −1 | K120174 | Deput Delta Xtend Reverse Shoulder | Depuy France | 2012 | 2 |
| 0 (this device) | K192855 | DELTA XTEND (TM) Reverse Shoulder System | Depuy (Ireland) | 2020 | — |
| +1 | K253624 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2026 | — |
| +1 | K211553 | Tecomet Global Unite Short Stem Instrumentation | Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc. | 2021 | — |
| +1 | 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 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K170748 | GLOBAL UNITE Platform Shoulder SystemSummary page 4…, KWS Classification panel Orthopedics panel Legally marketed Predicates: DePuy Synthes GLOBAL UNITE Platform Shoulder device(s) to which System (K170748) and DELTA XTEND Reverse Shoulder equivalence is claimed System (K071379, K120174) Reference Devic… | 2018 |
| * | K071379 | Delta Xtend Reverse Shoulder Modular StemSummary page 4…Predicates: DePuy Synthes GLOBAL UNITE Platform Shoulder device(s) to which System (K170748) and DELTA XTEND Reverse Shoulder equivalence is claimed System (K071379, K120174) Reference Device: Tornier Aequalis™ Ascend™ Flex Shoulder System… | 2007 |
| * | K120174 | Deput Delta Xtend Reverse ShoulderSummary page 4…es: DePuy Synthes GLOBAL UNITE Platform Shoulder device(s) to which System (K170748) and DELTA XTEND Reverse Shoulder equivalence is claimed System (K071379, K120174) Reference Device: Tornier Aequalis™ Ascend™ Flex Shoulder System (K122698)… | 2012 |
| † | K122698 | Aequalis Ascend Flex Shoulder System | 2013 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 23 of the 72 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K253624 (Depuy Ireland UC, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K170748.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 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 communited, 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…
Read the full statement (185 words)
The DELTA XTEND 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 communited, 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 HA coated and is intended for cementless use with the addition of screws for fixation. 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/K192855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K192855: DELTA XTEND (TM) Reverse Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K192855
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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