510(k) · Cleared
ClearedArthrex Univers II Shoulder Prosthesis
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 Dec 22, 2010 as substantially equivalent to K071032 (Arthrex, Inc., 2007) after a 28-day review. Its family tree reaches back 2 generations to 2001. 5 later devices descend from it.
- Decided
- Dec 22, 2010
- Review
- 28 days
- Class
- Class II
- Product code
- KWS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010124 (2001). 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK010124 Arthrex Univers 30 Shoulder ProsthesisArthrex, Inc. · 2001
- 1 generation backK071032 Arthrex Univers II Shoulder ProsthesisArthrex, Inc. · 2007
- This deviceK103466 Arthrex Univers II Shoulder ProsthesisArthrex, Inc. · 2010
- Descendant · cites it directly · 4 of its ownK131633 Arthrex Univers ApexArthrex, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK153115 Arthrex Univers Apex, Size 5 StemArthrex, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK171841 Arthrex Shoulder SystemArthrex, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK230513 Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK230366 Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023
Most influential descendants
Showing 5 of 5 · See all- K131633Arthrex Univers ApexArthrex, Inc. · 2013 · cites it directly4descendants
- K153115Arthrex Univers Apex, Size 5 StemArthrex, Inc. · 2015 · cites it directly2descendants
- K171841Arthrex Shoulder SystemArthrex, Inc. · 2018 · cites it directly1descendant
- K230513Arthrex Univers Apex OptiFit Humeral StemArthrex, Inc. · 2023 · 2 generations on0descendants
- K230366Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010124 | Arthrex Univers 30 Shoulder Prosthesis | Arthrex, Inc. | 2001 | — |
| −1 | K071032 | Arthrex Univers II Shoulder Prosthesis | Arthrex, Inc. | 2007 | — |
| 0 (this device) | K103466 | Arthrex Univers II Shoulder Prosthesis | Arthrex, Inc. | 2010 | — |
| +1 | K131633 | Arthrex Univers Apex | Arthrex, Inc. | 2013 | — |
| +1 | K153115 | Arthrex Univers Apex, Size 5 Stem | Arthrex, Inc. | 2015 | — |
| +1 | K171841 | Arthrex Shoulder System | Arthrex, Inc. | 2018 | — |
| +2 | K230513 | Arthrex Univers Apex OptiFit Humeral Stem | Arthrex, Inc. | 2023 | — |
| +2 | K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | Arthrex, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 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? (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 |
|---|---|---|---|
| * | K071032 | Arthrex Univers II Shoulder ProsthesisSummary page 2…osthesisissubstantially equivalent to the currently market-ed predicate device, Arthrex Univers.II Shou.lder tProsthesis (K(071032). DEPARTMENT OF HEALTH & HUMAN SERVICES PuLblic Hecalth Service… | 2007 |
What descends from it? (5)
3 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)
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 9 years and passes through 1 company; a new generation was cleared every 6.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K131633 (Arthrex, Inc., 2013) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K071032.
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. 2010, 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 Arthrex Univers II Shoulder Prosthesis is indicated in replacements(s) when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable.
The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103466 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103466: Arthrex Univers II Shoulder Prosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103466
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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