510(k) · Cleared
ClearedDelta Shoulder
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Nov 18, 2003 as substantially equivalent to K992119 (Biomet, Inc., 1999) and 2 other predicates after a 559-day review. Its family tree reaches back 3 generations to 1991. 1 of the 348 devices in its family, counting itself, has a Class I recall. 338 later devices descend from it.
- Decided
- Nov 18, 2003
- Review
- 559 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K911686 (1991). 9 ancestors in all, the oldest K800494 (1980). 338 later devices descend from it, 19 citing it directly. 1 of the 348 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 2 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 1 generation backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- This deviceK021478 Delta ShoulderDepuy, Inc. · 2003
- Descendant · cites it directly · 295 of its ownK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 280 of its ownK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · cites it directly · 277 of its ownK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- Descendant · cites it directly · 250 of its ownK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- Descendant · cites it directly · 248 of its ownK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
Showing 5 of 338 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K080642 Comprehensive Reverse Shoulder2 generations on · 2008
Most influential descendants
Showing 5 of 338 · See all- K062116Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006 · cites it directly295descendants
- K030941Aequalis Reversed Shoulder ProsthesisTornier · 2004 · cites it directly280descendants
- K041873Aequalis Reversed Shoulder ProsthesisTornier · 2004 · cites it directly277descendants
- K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · cites it directly250descendants
- K050316Aequalis Reversed Shoulder ProsthesisTornier · 2005 · cites it directly248descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −2 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| 0 (this device) | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| +1 | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +1 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| +1 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| +1 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 1 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 10 | 0 |
| 2012 | 15 | 0 |
| 2013 | 18 | 0 |
| 2014 | 14 | 0 |
| 2015 | 12 | 0 |
| 2016 | 14 | 0 |
| 2017 | 20 | 0 |
| 2018 | 19 | 0 |
| 2019 | 21 | 0 |
| 2020 | 23 | 0 |
| 2021 | 30 | 0 |
| 2022 | 21 | 0 |
| 2023 | 21 | 0 |
| 2024 | 19 | 0 |
| 2025 | 23 | 0 |
| 2026 | 27 | 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 |
|---|---|---|---|
| * | K992119 | Bio-Modular Shoulder SystemSummary page 1…the Delta Shoulder is substantiated by its similarity in indications for use, design, sterilization and packaging to the Biomet Bio-Modular and Bipolar Shoulder (K992 1 19 and K99 I585), and the Global Advantage Shoulder (K992065). The determination of substantial equivalence for thi… | 1999 |
| * | K991585 | Bipolar Shoulder Prosthesis | 1999 |
| * | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage Eccentric HeadSummary page 1…for use, design, sterilization and packaging to the Biomet Bio-Modular and Bipolar Shoulder (K992 1 19 and K99 I585), and the Global Advantage Shoulder (K992065). The determination of substantial equivalence for this device was based on a detailed device description, desig… | 1999 |
What descends from it? (338)
See all 33819 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062116 | Delta Cta Reverse Shoulder System Humeral Heads | 2006 | 295 |
| K030941 | Aequalis Reversed Shoulder Prosthesis | 2004 | 280 |
| K041873 | Aequalis Reversed Shoulder Prosthesis | 2004 | 277 |
| K062250 | Delta Xtend Reverse Shoulder System | 2007 | 250 |
| K050316 | Aequalis Reversed Shoulder Prosthesis | 2005 | 248 |
| K053274 | Anatomical Shoulder Inverse/Reverse | 2006 | 239 |
| K052906 | Zimmer Trabecular Metal Reverse Shoulder System | 2005 | 216 |
| K061439 | Aequalis Reversed Prosthesis | 2006 | 199 |
| K050315 | Delta Humeral Cups | 2005 | 196 |
| K071379 | Delta Xtend Reverse Shoulder Modular Stem | 2007 | 191 |
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 on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K062116 (DePuy Orthopaedics, Inc., 2006) has gone furthest, with 295 descendants of its own.
- 12 other devices also cite its predicate K992119.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
A Delta Total shoulder prosthesis is indicated for use in:
Grossly rotator cuff deficient joint with severe arthropathy or a previous failed joint replacement with a grossly rotator cuff deficient 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.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021478 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021478: Delta Shoulder.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021478
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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