510(k) · Cleared
ClearedArthrex Univers Revers Monoblock Stem Size 4/33
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · PHX Shoulder Prosthesis, Reverse Configuration
Cleared on Apr 10, 2023 as substantially equivalent to K130129 (Arthrex, Inc., 2013) and 4 other predicates after a 59-day review. Its family tree reaches back 15 generations to 1991.
- Decided
- Apr 10, 2023
- Review
- 59 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 15 generations to K911686 (1991). 77 ancestors in all, the oldest K800494 (1980). No later device cites it as a predicate yet.
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 11 generations between
- 3 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- 2 generations backK161782 Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2016
- 1 generation backK170414 Arthrex Univers Revers Apex Humeral StemsArthrex, Inc. · 2017
- This deviceK230366 Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023
Show all 15 generations
- Root · 15 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 14 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 13 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 12 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 11 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 10 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 8 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 7 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 6 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 5 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 4 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 3 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- 2 generations backK161782 Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2016
- 1 generation backK170414 Arthrex Univers Revers Apex Humeral StemsArthrex, Inc. · 2017
- This deviceK230366 Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −14 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −13 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −11 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −10 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −8 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −7 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −6 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −5 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| −4 | K130129 | Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2013 | — |
| −3 | K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex, Inc. | 2014 | — |
| −2 | K161782 | Arthrex Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2016 | — |
| −1 | K170414 | Arthrex Univers Revers Apex Humeral Stems | Arthrex, Inc. | 2017 | — |
| 0 (this device) | K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | Arthrex, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1987 | 4 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 3 | 0 |
| 2022 | 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? (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 |
|---|---|---|---|
| * | K130129 | Univers Revers Shoulder Prosthesis SystemSummary page 4…CFR 888.3690: Shoulder joint humeral (hemi- shoulder) metallic uncemented prosthesis Regulatory Class II Primary Predicate Device K130129: Univers Revers Shoulder Prothesis System Additional Predicates K170414: Arthrex Univers Revers Apex Humeral Stems… | 2013 |
| * | K170414 | Arthrex Univers Revers Apex Humeral StemsSummary page 4…der) metallic uncemented prosthesis Regulatory Class II Primary Predicate Device K130129: Univers Revers Shoulder Prothesis System Additional Predicates K170414: Arthrex Univers Revers Apex Humeral Stems K171841: Arthrex Shoulder System… | 2017 |
| * | K171841 | Arthrex Shoulder SystemSummary page 4…icate Device K130129: Univers Revers Shoulder Prothesis System Additional Predicates K170414: Arthrex Univers Revers Apex Humeral Stems K171841: Arthrex Shoulder System K181555: Arthrex Fracture Adapter Hemi Shoulder Prothesis… | 2018 |
| * | K181555 | Arthrex Fracture Adapter Hemi Shoulder ProsthesisSummary page 4…stem Additional Predicates K170414: Arthrex Univers Revers Apex Humeral Stems K171841: Arthrex Shoulder System K181555: Arthrex Fracture Adapter Hemi Shoulder Prothesis K221232: Univers Revers Humeral Cup Implant Device D… | 2018 |
| * | K221232 | Univers Revers Humeral Cup ImplantSummary page 4…K171841: Arthrex Shoulder System K181555: Arthrex Fracture Adapter Hemi Shoulder Prothesis K221232: Univers Revers Humeral Cup Implant Device Description This Traditional 510(k) premarket notification is submitted to… | 2022 |
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 32 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
- 10 of the 77 ancestors have a recall of any class.
- 5 other devices also cite its predicate K130129.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. 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 Univers Revers Shoulder Prosthesis System is indicated for…
Read the full statement (121 words)
The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. 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 Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to rotator cuff deficiency.
(Humeral) Stems are intended for cemented or cementless applications for use with Arthrex Humeral SutureCups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230366: Arthrex Univers Revers Monoblock Stem Size 4/33.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230366
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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