510(k) · Cleared
ClearedDelta Cta Reverse Shoulder System Humeral Heads
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 Aug 18, 2006 as substantially equivalent to K021478 (Depuy, Inc., 2003) and 1 other predicate after a 24-day review. Its family tree reaches back 4 generations to 1991. 1 of the 307 devices in its family, counting itself, has a Class I recall. 295 later devices descend from it.
- Decided
- Aug 18, 2006
- Review
- 24 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K911686 (1991). 11 ancestors in all, the oldest K800494 (1980). 295 later devices descend from it, 4 citing it directly. 1 of the 307 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 3 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 2 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 1 generation backK021478 Delta ShoulderDepuy, Inc. · 2003
- This deviceK062116 Delta Cta Reverse Shoulder System Humeral HeadsDePuy Orthopaedics, Inc. · 2006
- Descendant · cites it directly · 250 of its ownK062250 Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 191 of its ownK071379 Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007
- Descendant · cites it directly · 190 of its ownK063569 Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 177 of its ownK073688 Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and…Exactech, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 172 of its ownK080642 Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · Recalled (Class I)
Showing 5 of 295 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 295 · See all- K062250Delta Xtend Reverse Shoulder SystemDePuy Orthopaedics, Inc. · 2007 · cites it directly250descendants
- K071379Delta Xtend Reverse Shoulder Modular StemDePuy Orthopaedics, Inc. · 2007 · 2 generations on191descendants
- K063569Equinoxe Reverse Shoulder SystemExactech, Inc. · 2007 · cites it directly190descendants
- K073688Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking ScrewExactech, Inc. · 2008 · 2 generations on177descendants
- K080642Comprehensive Reverse ShoulderBiomet, Inc. · 2008 · 2 generations on172descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −3 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −2 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −1 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| 0 (this device) | K062116 | Delta Cta Reverse Shoulder System Humeral Heads | DePuy Orthopaedics, Inc. | 2006 | — |
| +1 | K062250 | Delta Xtend Reverse Shoulder System | DePuy Orthopaedics, Inc. | 2007 | 8 |
| +2 | K071379 | Delta Xtend Reverse Shoulder Modular Stem | DePuy Orthopaedics, Inc. | 2007 | — |
| +1 | K063569 | Equinoxe Reverse Shoulder System | Exactech, Inc. | 2007 | 13 |
| +2 | 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 |
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 | 3 | 0 |
| 2008 | 6 | 1 |
| 2009 | 1 | 0 |
| 2010 | 7 | 0 |
| 2011 | 8 | 0 |
| 2012 | 9 | 0 |
| 2013 | 14 | 0 |
| 2014 | 12 | 0 |
| 2015 | 11 | 0 |
| 2016 | 11 | 0 |
| 2017 | 19 | 0 |
| 2018 | 17 | 0 |
| 2019 | 19 | 0 |
| 2020 | 22 | 0 |
| 2021 | 29 | 0 |
| 2022 | 21 | 0 |
| 2023 | 21 | 0 |
| 2024 | 18 | 0 |
| 2025 | 22 | 0 |
| 2026 | 25 | 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? (2)
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 CTA Head, K(000575 DEVICE DESCRIPTION: The Delta CTA Reverse S… | 2003 |
| * | K000575 | Global Advantage Extended Humeral HeadSummary page 2…s similarity in intended use, indications for use, materials and design to the DePuy Delta CTA Reverse Shoulder System (K02147S) and the DePuy Global Advantage CTA Head (K000575). 6 DEPARTMENT… | 2000 |
What descends from it? (295)
See all 2954 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 on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K062250 (DePuy Orthopaedics, Inc., 2007) has gone furthest, with 250 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.
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 CTA 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.
The metaglene component is HA coated and is intended for cementless application with the addition of screws for fixation. All other components are intended fbr cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062116: Delta Cta Reverse Shoulder System Humeral Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062116
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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