# K130675: Arthrex Univers II CA Heads

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Oct 30, 2013 after 231 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K151527: Arthrex Univers Revers CA Heads and Adapters (2016), 3 descendants of its own
- K171841: Arthrex Shoulder System (2018), 1 descendant of its own
- K233260: Univers Revers CA Head and Adapter (2024), 0 descendants of its own
- K230366: Arthrex Univers Revers Monoblock Stem Size 4/33 (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K130675
Methodology: https://510kreport.com/methodology