510(k) · Cleared
ClearedUnivers Revers Humeral Cup Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Cleared on May 19, 2022 as substantially equivalent to K161782 (Arthrex, Inc., 2016) after a 20-day review. Its family tree reaches back 14 generations to 1991. 1 later device descends from it.
- Decided
- May 19, 2022
- Review
- 20 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 14 generations to K911686 (1991). 45 ancestors in all, the oldest K800494 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 10 generations between
- 3 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 2 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- 1 generation backK161782 Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2016
- This deviceK221232 Univers Revers Humeral Cup ImplantArthrex, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK230366 Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023
Show all 14 generations
- Root · 14 generations backK911686 Global Total Shoulder, Uncement Humeral Hemi-ShoulDepuy, Inc. · 1991
- 13 generations backK984541 Global FX Humeral Stem, Global Advantage Humeral HeadDePuy Orthopaedics, Inc. · 1999
- 12 generations backK992065 Global Advantage Shoulder, Global Advantage Humeral Stem, Global…DePuy Orthopaedics, Inc. · 1999
- 11 generations backK021478 Delta ShoulderDepuy, Inc. · 2003
- 10 generations backK030941 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 9 generations backK041873 Aequalis Reversed Shoulder ProsthesisTornier · 2004
- 8 generations backK050316 Aequalis Reversed Shoulder ProsthesisTornier · 2005
- 7 generations backK061439 Aequalis Reversed ProsthesisTornier · 2006
- 6 generations backK071948 Aequalis Reversed AdapterTornier · 2007
- 5 generations backK082120 Aequalis Reversed Fracture Shoulder ProthesisTornier · 2008
- 4 generations backK100142 Aequalis Reversed Shoulder ProsthesisTornier · 2010
- 3 generations backK130129 Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2013
- 2 generations backK142863 Univers Rivers Shoulder Prosthesis SystemArthrex, Inc. · 2014
- 1 generation backK161782 Arthrex Univers Revers Shoulder Prosthesis SystemArthrex, Inc. · 2016
- This deviceK221232 Univers Revers Humeral Cup ImplantArthrex, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K911686 | Global Total Shoulder, Uncement Humeral Hemi-Shoul | Depuy, Inc. | 1991 | — |
| −13 | K984541 | Global FX Humeral Stem, Global Advantage Humeral Head | DePuy Orthopaedics, Inc. | 1999 | — |
| −12 | K992065 | Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage… | DePuy Orthopaedics, Inc. | 1999 | — |
| −11 | K021478 | Delta Shoulder | Depuy, Inc. | 2003 | — |
| −10 | K030941 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −9 | K041873 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2004 | — |
| −8 | K050316 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2005 | — |
| −7 | K061439 | Aequalis Reversed Prosthesis | Tornier | 2006 | — |
| −6 | K071948 | Aequalis Reversed Adapter | Tornier | 2007 | — |
| −5 | K082120 | Aequalis Reversed Fracture Shoulder Prothesis | Tornier | 2008 | — |
| −4 | K100142 | Aequalis Reversed Shoulder Prosthesis | Tornier | 2010 | — |
| −3 | K130129 | Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2013 | — |
| −2 | K142863 | Univers Rivers Shoulder Prosthesis System | Arthrex, Inc. | 2014 | — |
| −1 | K161782 | Arthrex Univers Revers Shoulder Prosthesis System | Arthrex, Inc. | 2016 | — |
| 0 (this device) | K221232 | Univers Revers Humeral Cup Implant | Arthrex, Inc. | 2022 | — |
| +1 | 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 | 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 |
|---|---|---|
| 2023 | 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 HSD? 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 HSD device
- #1 K191433 AGILON® XO Shoulder Replacement Systemscore 13.8 · 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? (1)
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 |
|---|---|---|---|
| * | K161782 | Arthrex Univers Revers Shoulder Prosthesis SystemSummary page 4…mented prosthesis 21 CFR 888.3660: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class II Predicate Device K161782: Arthrex Univers Revers Shoulder Prosthesis System Reference Device K142863: Arthrex Univers Revers Shoulder Prosthesis Syst… | 2016 |
| † | K142863 | Univers Rivers Shoulder Prosthesis System | 2014 |
| † | K191960 | Arthrex Univers Revers Modular Glenoid System | 2019 |
| † | K173900 | Arthrex Univers Revers Modular Glenoid System | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 31 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 6 of the 45 ancestors have a recall of any class.
- Of its descendants, K230366 (Arthrex, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K161782.
How does its category compare?
All HSD devicesHSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · HSD
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HSD
145in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSD
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSD
757in 2025
MAUDE reports naming product code HSD, 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 | 4 | 72 | 0 | 128 |
| 2008 | 3 | 92 | 2 | 259 |
| 2009 | 0 | — | 2 | 156 |
| 2010 | 0 | — | 0 | 225 |
| 2011 | 2 | — | 0 | 241 |
| 2012 | 2 | — | 0 | 254 |
| 2013 | 4 | 218 | 0 | 288 |
| 2014 | 1 | — | 0 | 434 |
| 2015 | 0 | — | 0 | 574 |
| 2016 | 3 | 145 | 0 | 784 |
| 2017 | 0 | — | 3 | 985 |
| 2018 | 1 | — | 1 | 649 |
| 2019 | 0 | — | 0 | 830 |
| 2020 | 2 | — | 1 | 658 |
| 2021 | 0 | — | 0 | 573 |
| 2022 | 1 | — | 0 | 508 |
| 2023 | 0 | — | 0 | 586 |
| 2024 | 1 | — | 0 | 693 |
| 2025 | 0 | — | 0 | 757 |
| 2026 | 0 | — | 0 | — |
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 (122 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 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/K221232 · printed Nov 5, 2026
Cite this page
510(k) Report. “K221232: Univers Revers Humeral Cup Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K221232
Report an extraction error
Are you the manufacturer?
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