510(k) · Cleared
ClearedARROW Reverse Shoulder long keel and short keel glenoid base
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fournitures Hospitalieres Industrie · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Mar 20, 2015 as substantially equivalent to K112193 (Fournitures Hospitalieres Industrie, 2012) and 1 other predicate after a 175-day review. Its family tree reaches back 12 generations to 1991. 5 later devices descend from it.
- Decided
- Mar 20, 2015
- Review
- 175 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K911686 (1991). 75 ancestors in all, the oldest K790987 (1979). 5 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 8 generations between
- 3 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 2 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 1 generation backK103251 Duocentric ReversedAston Medical · 2011
- This deviceK142778 ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015
- Descendant · cites it directly · 4 of its ownK162068 ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
- Descendant · cites it directly · 3 of its ownK171789 ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
- Descendant · 2 generations on · 1 of its ownK242253 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024
- Descendant · 3 generations on · 0 of its ownK252411 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025
- Descendant · 2 generations on · 0 of its ownK232226 ARROW Off-Centred Humeral InsertFH Industrie · 2023
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 backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 5 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 4 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 3 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 2 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 1 generation backK103251 Duocentric ReversedAston Medical · 2011
- This deviceK142778 ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015
Most influential descendants
Showing 5 of 5 · See all- K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017 · cites it directly4descendants
- K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018 · cites it directly3descendants
- K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024 · 2 generations on1descendant
- K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025 · 3 generations on0descendants
- K232226ARROW Off-Centred Humeral InsertFH Industrie · 2023 · 2 generations on0descendants
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 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −5 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −4 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −3 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −2 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| −1 | K103251 | Duocentric Reversed | Aston Medical | 2011 | — |
| 0 (this device) | K142778 | ARROW Reverse Shoulder long keel and short keel glenoid base | Fournitures Hospitalieres Industrie | 2015 | — |
| +1 | K162068 | ARROW Anatomical Porous glenoid | Fournitures Hospitalieres Industrie | 2017 | — |
| +1 | K171789 | ARROW Reverse Porous Glenoid | Fournitures Hospitalieres Industrie | 2018 | — |
| +2 | K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2024 | — |
| +3 | K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2025 | — |
| +2 | K232226 | ARROW Off-Centred Humeral Insert | FH Industrie | 2023 | — |
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 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 6 | 0 |
| 2001 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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.
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? (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 |
|---|---|---|---|
| * | K112193 | Arrow Reverse Shoulder SystemSummary page 3…base. These devices are designed to articulate with ARROW® Reverse Shoulder System cleared in K112193. Indications for Use: The ARROW£ Reverse Shoulder long keel and short ke… | 2012 |
| * | K103251 | Duocentric ReversedSummary page 4…Manufacturer: Aston Medical Device Trade Name: DUOCENTRIC Reversed 510 (K): K103251 34… | 2011 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
- 17 of the 75 ancestors have a recall of any class.
- Of its descendants, K162068 (Fournitures Hospitalieres Industrie, 2017) has gone furthest, with 4 descendants of its own.
- 7 other devices also cite its predicate K112193.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 ARROW® Reverse Shoulder long keel and short keel glenoid base is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device. The humeral stem is intended for cemented or cementless application while the metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142778: ARROW Reverse Shoulder long keel and short keel glenoid base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142778
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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