510(k) · Cleared
Recalled · 2008Smith & Nephew, Inc., Promos Reverse Shoulder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Sep 5, 2008 as substantially equivalent to K063578 (Plus Orthopedics AG, 2007) and 4 other predicates after a 149-day review. Its family tree reaches back 7 generations to 1991. 52 later devices descend from it. It has been recalled 2 times.
- Decided
- Sep 5, 2008
- Review
- 149 days
- Class
- Class II
- Product code
- PHX
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 7 generations to K911686 (1991). 23 ancestors in all, the oldest K800494 (1980). 52 later devices descend from it, 6 citing it directly.
- Root · 7 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 6 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 5 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 4 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 3 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 2 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 1 generation backK053274 Anatomical Shoulder Inverse/ReverseZimmer GmbH · 2006 · Recalled
- This deviceK081016 Smith & Nephew, Inc., Promos Reverse Shoulder SystemSmith & Nephew, Inc. · 2008
- Descendant · cites it directly · 44 of its ownK110598 SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · Recalled
- Descendant · 2 generations on · 31 of its ownK113254 SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular…Lima Corporate S.P.A. · 2012
- Descendant · 3 generations on · 20 of its ownK133349 SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014
- Descendant · 3 generations on · 13 of its ownK153722 SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016
- Descendant · cites it directly · 13 of its ownK142139 SMR 40MM GlenosphereLima Corporate S.P.A. · 2014
Showing 5 of 52 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 52 · See all- K110598SMR Reverse Shoulder SystemLima Corporate S.P.A. · 2011 · cites it directly44descendants
- K113254SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone ScrewsLima Corporate S.P.A. · 2012 · 2 generations on31descendants
- K133349SMR TT Metal Back GlenoidLima Corporate S.P.A. · 2014 · 3 generations on20descendants
- K153722SMR 3-Pegs GlenoidsLima Corporate S.P.A. · 2016 · 3 generations on13descendants
- K142139SMR 40MM GlenosphereLima Corporate S.P.A. · 2014 · cites it directly13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −6 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −5 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −4 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −3 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −2 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −1 | K053274 | Anatomical Shoulder Inverse/Reverse | Zimmer GmbH | 2006 | 3 |
| 0 (this device) | K081016 | Smith & Nephew, Inc., Promos Reverse Shoulder System | Smith & Nephew, Inc. | 2008 | — |
| +1 | K110598 | SMR Reverse Shoulder System | Lima Corporate S.P.A. | 2011 | 1 |
| +2 | K113254 | SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular… | Lima Corporate S.P.A. | 2012 | — |
| +3 | K133349 | SMR TT Metal Back Glenoid | Lima Corporate S.P.A. | 2014 | — |
| +3 | K153722 | SMR 3-Pegs Glenoids | Lima Corporate S.P.A. | 2016 | — |
| +1 | K142139 | SMR 40MM Glenosphere | Lima Corporate S.P.A. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 4 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K063578 | Promos Modular Shoulder SystemSummary page 4…ons for use, design features, operational principles, and material composition to the following predicate devices — PLUS Orthopedics AG's PROMOS Modular Shoulder System {K063578), Depuy Orthopedics' DELTA CTA Reverse Shoulder Prosthesis (K021478}, the Tomier S.A.S. Aequalis Reverse Shoulder Prosthesis (K04… | 2007 |
| * | K021478 | Delta ShoulderSummary page 4…omposition to the following predicate devices — PLUS Orthopedics AG's PROMOS Modular Shoulder System {K063578), Depuy Orthopedics' DELTA CTA Reverse Shoulder Prosthesis (K021478}, the Tomier S.A.S. Aequalis Reverse Shoulder Prosthesis (K041873), the Encore Medical Reverse Shoulder Prosthesis Sysiem {K04106… | 2003 |
| * | K041873 | Aequalis Reversed Shoulder ProsthesisSummary page 4…G's PROMOS Modular Shoulder System {K063578), Depuy Orthopedics' DELTA CTA Reverse Shoulder Prosthesis (K021478}, the Tomier S.A.S. Aequalis Reverse Shoulder Prosthesis (K041873), the Encore Medical Reverse Shoulder Prosthesis Sysiem {K041066), and Zimmer's Anatomical Inverse/Reverse Shoulder (K053274). R… | 2004 |
| * | K041066 | Encore Reverse Shoulder ProsthesisSummary page 4…DELTA CTA Reverse Shoulder Prosthesis (K021478}, the Tomier S.A.S. Aequalis Reverse Shoulder Prosthesis (K041873), the Encore Medical Reverse Shoulder Prosthesis Sysiem {K041066), and Zimmer's Anatomical Inverse/Reverse Shoulder (K053274). Revised_Summary of Safety & Effectiveness.doc | 2005 |
| * | K053274 | Anatomical Shoulder Inverse/ReverseSummary page 4…S.A.S. Aequalis Reverse Shoulder Prosthesis (K041873), the Encore Medical Reverse Shoulder Prosthesis Sysiem {K041066), and Zimmer's Anatomical Inverse/Reverse Shoulder (K053274). Revised_Summary of Safety & Effectiveness.doc | 2006 |
What descends from it? (52)
See all 526 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 21, 2008 | Not classified | Z-0960-2009 | Other | The product was breaking during use. |
| Nov 21, 2008 | Not classified | Z-0961-2009 | Other | The product was breaking during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 7 of the 23 ancestors have a recall of any class.
- Of its descendants, K110598 (Lima Corporate S.P.A., 2011) has gone furthest, with 44 descendants of its own.
- 5 other devices also cite its predicate K063578.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 PROMOS Reverse Shoulder System 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 implants and a functional deltoid muscle is necessary to use the device.
The glenoid baseplate is intended for cementless application with the addition of screws for fixation.
The humeral stem and body compenents are intended for cementless use.
The imptants of the PROMOS Reverse Shoulder System are single u%
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/K081016 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081016: Smith & Nephew, Inc., Promos Reverse Shoulder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081016
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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