510(k) · Cleared
ClearedArthrex Univers Revers CA Heads and Adapters
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 Apr 19, 2016 as substantially equivalent to K130675 (Arthrex, Inc., 2013) after a 316-day review. Its family tree reaches back 1 generation to 2013. 3 later devices descend from it.
- Decided
- Apr 19, 2016
- Review
- 316 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130675 (2013). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK130675 Arthrex Univers II CA HeadsArthrex, Inc. · 2013
- This deviceK151527 Arthrex Univers Revers CA Heads and AdaptersArthrex, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK171841 Arthrex Shoulder SystemArthrex, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK233260 Univers Revers CA Head and AdapterArthrex, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK230366 Arthrex Univers Revers Monoblock Stem Size 4/33Arthrex, Inc. · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130675 | Arthrex Univers II CA Heads | Arthrex, Inc. | 2013 | — |
| 0 (this device) | K151527 | Arthrex Univers Revers CA Heads and Adapters | Arthrex, Inc. | 2016 | — |
| +1 | K171841 | Arthrex Shoulder System | Arthrex, Inc. | 2018 | — |
| +1 | K233260 | Univers Revers CA Head and Adapter | Arthrex, Inc. | 2024 | — |
| +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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K130675 | Arthrex Univers II CA HeadsSummary page 4…ined cemented prosthesis, CFR 888.3660 Predicate Device Primary Predicate K130675: Arthrex Univers II CA Heads Reference Predicates: K130129 / 142863:… | 2013 |
| † | K130129 | Univers Revers Shoulder Prosthesis System | 2013 |
| † | K142863 | Univers Rivers Shoulder Prosthesis System | 2014 |
What descends from it? (3)
2 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?
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. 2016, 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 Arthrex Univers Revers CA Heads and Adapters are indicated for
salvage of a failed reverse total shoulder, with an irreparable rotator cuff tear and a well-fixed humeral stem, to an anatomic hemi-shoulder replacement; or
conversion of a primary reverse total shoulder, for the relief of pain secondary to severe rotator cuff arthropathy and an irreparable rotator cuff tear, to anatomic hemi-shoulder replacement when insufficient glenoid bone stock is encountered intraoperatively after the humeral stem has been implanted.
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
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/K151527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151527: Arthrex Univers Revers CA Heads and Adapters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151527
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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