510(k) · Cleared
ClearedDuocentric Reversed
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aston Medical · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Oct 28, 2011 as substantially equivalent to K091751 (DePuy Orthopaedics, Inc., 2009) and 3 other predicates after a 359-day review. Its family tree reaches back 11 generations to 1991. 7 later devices descend from it.
- Decided
- Oct 28, 2011
- Review
- 359 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K911686 (1991). 42 ancestors in all, the oldest K800494 (1980). 7 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 7 generations between
- 3 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 2 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 1 generation backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- This deviceK103251 Duocentric ReversedAston Medical · 2011
- Descendant · cites it directly · 5 of its ownK142778 ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015
- Descendant · 2 generations on · 4 of its ownK162068 ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017
- Descendant · 2 generations on · 3 of its ownK171789 ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018
- Descendant · 3 generations on · 1 of its ownK242253 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024
- Descendant · 4 generations on · 0 of its ownK252411 JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025
Show all 11 generations
- Root · 11 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 9 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 8 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 7 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 6 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 5 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 4 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 3 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 2 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 1 generation backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- This deviceK103251 Duocentric ReversedAston Medical · 2011
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K142778ARROW Reverse Shoulder long keel and short keel glenoid baseFournitures Hospitalieres Industrie · 2015 · cites it directly5descendants
- K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie · 2017 · 2 generations on4descendants
- K171789ARROW Reverse Porous GlenoidFournitures Hospitalieres Industrie · 2018 · 2 generations on3descendants
- K242253JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2024 · 3 generations on1descendant
- K252411JARVIS Glenoid Reverse Shoulder ProsthesisFH Industrie · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −10 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −9 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −8 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −7 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −6 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −5 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −4 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −3 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −2 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −1 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| 0 (this device) | K103251 | Duocentric Reversed | Aston Medical | 2011 | — |
| +1 | K142778 | ARROW Reverse Shoulder long keel and short keel glenoid base | Fournitures Hospitalieres Industrie | 2015 | — |
| +2 | K162068 | ARROW Anatomical Porous glenoid | Fournitures Hospitalieres Industrie | 2017 | — |
| +2 | K171789 | ARROW Reverse Porous Glenoid | Fournitures Hospitalieres Industrie | 2018 | — |
| +3 | K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2024 | — |
| +4 | K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K091751 | Depuy Delta Xtend Reverse Shoulder XLK CupSummary page 4…October 28, 2011 DUOCENTRIC® Reversed Reverse shoulder prosthesis Class II, 21 CFR 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthests KwWS K091751 — Depuy Orthopaedic, Inc. USA - Depuy Delta Xtend Reverse Shoulder - cleared 7/14/2009 K021478 — Depuy Orthopaedic, Inc. USA — De… | 2009 |
| * | K021478 | Delta ShoulderSummary page 4…Shoulder joint metal/polymer semi-constrained cemented prosthests KwWS K091751 — Depuy Orthopaedic, Inc. USA - Depuy Delta Xtend Reverse Shoulder - cleared 7/14/2009 K021478 — Depuy Orthopaedic, Inc. USA — Delta Shoulder — cleared 11/18/2003 K100142 - Tomier, France — Aequalis Reversed Shoulder Prosth… | 2003 |
| * | K100142 | Aequalis Reversed Shoulder ProsthesisSummary page 4…91751 — Depuy Orthopaedic, Inc. USA - Depuy Delta Xtend Reverse Shoulder - cleared 7/14/2009 K021478 — Depuy Orthopaedic, Inc. USA — Delta Shoulder — cleared 11/18/2003 K100142 - Tomier, France — Aequalis Reversed Shoulder Prosthesis — cleared 5/6/2010 K083274 — Zimmer, Inc. USA — Anatomical Shoulder™ I… | 2010 |
| * | K053274 | Anatomical Shoulder Inverse/Reverse Our OCR of the scanned summary read K083274, FDA’s number for Worldwide Medical Technologies Anchor Marker, Marker… (Biocompatibles, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Zimmer Anatomical Shoulder Inverse/Reverse”. | 2006 |
What descends from it? (7)
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 20 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 42 ancestors have a recall of any class.
- Of its descendants, K142778 (Fournitures Hospitalieres Industrie, 2015) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K091751.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Implantation of a joint prosthesis is to be considered only when all other surgical options have been carefully examined and found less appropriate. The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older).…
Read the full statement (155 words)
Implantation of a joint prosthesis is to be considered only when all other surgical options have been carefully examined and found less appropriate.
The Duocentric® Reversed shoulder prosthesis is indicated for use in case of gross rotator cuff deficiency including when it is associated with osteoarthritis, revision of previous arthroplasty or complex fracture of the humerus (3 fragments or more) in an older population (e.g. 65 years of age or older).
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 humeral stem is intended for use with cement when polished or without cement when coated with Hydroxyapatite. All other components are intended for cementless use only. The gienoid baseplate is intended for éementless application with the addition of three screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapafite on its posterior side.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K103251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103251: Duocentric Reversed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103251
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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