510(k) · Cleared
ClearedArthrex Univers II CA Heads
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 Oct 30, 2013 after a 231-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Oct 30, 2013
- Review
- 231 days
- Class
- Class II
- Product code
- HSD
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK130675 Arthrex Univers II CA HeadsArthrex, Inc. · 2013
- Descendant · cites it directly · 3 of its ownK151527 Arthrex Univers Revers CA Heads and AdaptersArthrex, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK171841 Arthrex Shoulder SystemArthrex, Inc. · 2018
- Descendant · 2 generations on · 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 4 of 4 · See all- K151527Arthrex Univers Revers CA Heads and AdaptersArthrex, Inc. · 2016 · cites it directly3descendants
- K171841Arthrex Shoulder SystemArthrex, Inc. · 2018 · cites it directly1descendant
- K233260Univers Revers CA Head and AdapterArthrex, Inc. · 2024 · 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 |
|---|---|---|---|---|---|
| 0 (this device) | K130675 | Arthrex Univers II CA Heads | Arthrex, Inc. | 2013 | — |
| +1 | K151527 | Arthrex Univers Revers CA Heads and Adapters | Arthrex, Inc. | 2016 | — |
| +1 | K171841 | Arthrex Shoulder System | Arthrex, Inc. | 2018 | — |
| +2 | 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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K151527 (Arthrex, Inc., 2016) has gone furthest, with 3 descendants of its own.
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. 2013, 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 | — |
https://510kreport.com/device/K130675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130675: Arthrex Univers II CA Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130675
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026