510(k) · Cleared
ClearedUnivers Revers Shoulder Prosthesis System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Cleared on May 31, 2013 as substantially equivalent to K053274 (Zimmer GmbH, 2006) and 1 other predicate after a 134-day review. Its family tree reaches back 11 generations to 1991. 28 later devices descend from it.
- Decided
- May 31, 2013
- Review
- 134 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K911686 (1991). 42 ancestors in all, the oldest K800494 (1980). 28 later devices descend from it, 6 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 deviceK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- Descendant · cites it directly · 27 of its ownK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- Descendant · 2 generations on · 17 of its ownK173900 Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018
- Descendant · 3 generations on · 13 of its ownK193372 Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc. · 2020
- Descendant · 3 generations on · 5 of its ownK202611 Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021
- Descendant · 4 generations on · 4 of its ownK231911 Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A. · 2023
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 deviceK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K142863Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014 · cites it directly27descendants
- K173900Arthrex Univers Revers Modular Glenoid SystemArthrex, Inc. · 2018 · 2 generations on17descendants
- K193372Univers Revers Modular Glenoid System (Augemented baseplates)Arthrex, Inc. · 2020 · 3 generations on13descendants
- K202611Catalyst OrthoScience R1 Reverse Shoulder SystemCatalyst Orthoscience, Inc. · 2021 · 3 generations on5descendants
- K231911Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A. · 2023 · 4 generations on4descendants
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) | K130129 | Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2013 | — |
| +1 | K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex, Inc. | 2014 | — |
| +2 | K173900 | Arthrex Univers Revers Modular Glenoid System | Arthrex, Inc. | 2018 | — |
| +3 | K193372 | Univers Revers Modular Glenoid System (Augemented baseplates) | Arthrex, Inc. | 2020 | — |
| +3 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2021 | — |
| +4 | K231911 | Glenoid Reconstruction System – Full Wedge Baseplate | Medacta International S.A. | 2023 | — |
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 |
| 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 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 |
|---|---|---|---|
| * | K053274 | Anatomical Shoulder Inverse/ReverseSummary page 4…n Name Shoulder Prosthesis Product Code -Classification Name CFR KWS - Prosthesis, Shoulder, semi-constrained metal/polymer, cemented, CFR 888.3660 Predicate Device K053274: Zimmer Anatomical Shoulder System K100142: Torneir Aequalis Revers Shoulder Prosthesis Purpose of Submission This traditional… | 2006 |
| * | K100142 | Aequalis Reversed Shoulder ProsthesisSummary page 4…Classification Name CFR KWS - Prosthesis, Shoulder, semi-constrained metal/polymer, cemented, CFR 888.3660 Predicate Device K053274: Zimmer Anatomical Shoulder System K100142: Torneir Aequalis Revers Shoulder Prosthesis Purpose of Submission This traditional S10(k} premarket notification is submitted… | 2010 |
What descends from it? (28)
See all 286 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142863 | Univers Rivers Shoulder Prosthesis System | 2014 | 27 |
| K161782 | Arthrex Univers Revers Shoulder Prosthesis System | 2016 | 4 |
| K181555 | Arthrex Fracture Adapter Hemi Shoulder Prosthesis | 2018 | 1 |
| K171841 | Arthrex Shoulder System | 2018 | 1 |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | 2023 | 0 |
| K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | 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 22 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, K142863 (Arthrex, Inc., 2014) has gone furthest, with 27 descendants of its own.
- 12 other devices also cite its predicate K053274.
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. 2013, 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 Univers Revers Shoulder Prosthesis is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previous failed joint replacement with 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 glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.
The uncoated cup and stem are intended for cemented use, all other components are for cementless use only.
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/K130129 · printed Nov 5, 2026
Cite this page
510(k) Report. “K130129: Univers Revers Shoulder Prosthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K130129
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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