510(k) · Cleared
ClearedUnivers Rivers Shoulder Prosthesis System
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 Nov 25, 2014 as substantially equivalent to K053274 (Zimmer GmbH, 2006) and 1 other predicate after a 55-day review. Its family tree reaches back 12 generations to 1991. 27 later devices descend from it.
- Decided
- Nov 25, 2014
- Review
- 55 days
- Class
- Class II
- Product code
- PHX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K911686 (1991). 43 ancestors in all, the oldest K800494 (1980). 27 later devices descend from it, 6 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 backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- This deviceK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- Descendant · cites it directly · 17 of its ownK173900 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018
- Descendant · 2 generations on · 13 of its ownK193372 Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · 3 generations on · 4 of its ownK231911 Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A. · 2023
- Descendant · cites it directly · 4 of its ownK161782 Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2016
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 backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- This deviceK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
Showing 5 of 27 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 27 · See all- K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018 · cites it directly17descendants
- K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc. · 2020 · 2 generations on13descendants
- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 2 generations on5descendants
- K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A. · 2023 · 3 generations on4descendants
- K161782Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2016 · cites it directly4descendants
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 | K130129 | Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2013 | — |
| 0 (this device) | K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex, Inc. | 2014 | — |
| +1 | K173900 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | 2018 | — |
| +2 | K193372 | Univers Revers Modular Glenoid System (Augemented baseplates) | Arthrex, Inc. | 2020 | — |
| +2 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +3 | K231911 | Glenoid Reconstruction System – Full Wedge Baseplate | Medacta International S.A. | 2023 | — |
| +1 | K161782 | Arthrex Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2016 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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? (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 |
|---|---|---|---|
| * | K053274 | Anatomical Shoulder Inverse/ReverseSummary page 4…cation Name PHX – Shoulder joint metal/polymer semi‐constrained cemented CFR prosthesis, CFR 888.3660 Predicate Device K053274: Zimmer Anatomical Shoulder System K130129: Arthrex Univers Revers Prosthesis Shoulder System… | 2006 |
| * | K130129 | Univers Revers Shoulder Prosthesis SystemSummary page 4…CFR prosthesis, CFR 888.3660 Predicate Device K053274: Zimmer Anatomical Shoulder System K130129: Arthrex Univers Revers Prosthesis Shoulder System Purpose of Submission This traditional 510(k) premarket notifica… | 2013 |
What descends from it? (27)
See all 276 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173900 | Arthrex Univers Revers Modular Glenoid System | 2018 | 17 |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis System | 2016 | 4 |
| K172371 | Arthrex UNIVERS REVERS COATED BASEPLATE | 2018 | 3 |
| K181555 | Arthrex Fracture Adapter Hemi Shoulder Prosthesis | 2018 | 1 |
| K171841 | Arthrex Shoulder System | 2018 | 1 |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | 2023 | 0 |
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.
- Of its descendants, K173900 (Arthrex, Inc., 2018) has gone furthest, with 17 descendants of its own.
- 12 other devices also cite its predicate K053274.
How does its category compare?
All PHX devicesPHX Shoulder Prosthesis, Reverse Configuration: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 (116 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 gross rotator cuff deficiency.
(Humeral) Stems are intended for cemented or cementless applications. 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/K142863 · printed Nov 4, 2026
Cite this page
510(k) Report. “K142863: Univers Rivers Shoulder Prosthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K142863
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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