510(k) · Cleared
ClearedDuocentric Reversed Shoulder Prosthesis
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aston Medical · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on Feb 7, 2014 as substantially equivalent to K103251 (Aston Medical, 2011) and 1 other predicate after an 87-day review. Its family tree reaches back 12 generations to 1991.
- Decided
- Feb 7, 2014
- Review
- 87 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K911686 (1991). 43 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- 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 deviceK133462 Duocentric Reversed Shoulder ProsthesisAston Medical · 2014
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 deviceK133462 Duocentric Reversed Shoulder ProsthesisAston Medical · 2014
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) | K133462 | Duocentric Reversed Shoulder Prosthesis | Aston Medical | 2014 | — |
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 |
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 KWS? 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 KWS device
- #1 K220847 AETOS Shoulder Systemscore 21.1 · 16 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 |
|---|---|---|---|
| * | K103251 | Duocentric ReversedSummary page 4…ymer semi-constrained cemented prosthesis KWS Class 11, 21 CFR 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis HSD Predicate Devices: K103251 - Aston Medical, France — Duocentric® Reversed Shoulder Prosthesis — cleared 10/28/2011 K091751 - Depuy Orthopaedic, Inc. USA — D… | 2011 |
| * | K091751 | Depuy Delta Xtend Reverse Shoulder XLK CupSummary page 4…l (hemi-shoulder) metallic uncemented prosthesis HSD Predicate Devices: K103251 - Aston Medical, France — Duocentric® Reversed Shoulder Prosthesis — cleared 10/28/2011 K091751 - Depuy Orthopaedic, Inc. USA — Depuy Delta Xtend Reverse Shoulder - cleared 7/14/2009 Device Description: . The Duocentric® Re… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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 23 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 6 of the 43 ancestors have a recall of any class.
- 1 other device also cites its predicate K103251.
How does its category compare?
All KWS devicesKWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KWS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWS
97in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWS
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWS
2,281in 2025
MAUDE reports naming product code KWS, 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 | 2 | — | 21 | 158 |
| 2008 | 4 | 37 | 29 | 238 |
| 2009 | 4 | 108 | 0 | 294 |
| 2010 | 7 | 33 | 10 | 393 |
| 2011 | 11 | 90 | 11 | 486 |
| 2012 | 7 | 86 | 10 | 542 |
| 2013 | 12 | 120 | 0 | 818 |
| 2014 | 7 | 89 | 1 | 1,066 |
| 2015 | 8 | 129 | 0 | 1,170 |
| 2016 | 10 | 114 | 1 | 970 |
| 2017 | 7 | 120 | 4 | 1,681 |
| 2018 | 4 | 152 | 1 | 1,545 |
| 2019 | 9 | 106 | 2 | 1,728 |
| 2020 | 3 | 98 | 5 | 1,567 |
| 2021 | 5 | 151 | 0 | 1,358 |
| 2022 | 5 | 158 | 0 | 1,268 |
| 2023 | 4 | 250 | 2 | 1,750 |
| 2024 | 2 | — | 0 | 2,122 |
| 2025 | 3 | 97 | 0 | 2,281 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (174 words)
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 glenoid baseplate is intended for cementless application with the addition of three
screws for fixation. It is coated with a double layer of pure Titanium and Hydroxyapatite
on its posterior side.
The additional component bail out head is intended when, during primary surgery for the
Duocentric® Reversed shoulder prosthesis 1) the glenoid bone stock appears to be
insufficient to bear the implant of the glenoid components, or 2) the glenoid bone
fractures intra-operatively.
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/K133462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133462: Duocentric Reversed Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133462
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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