# K010124: Arthrex Univers 30 Shoulder Prosthesis

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Apr 6, 2001 after 80 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
149 later devices descend from it; 5 cite it directly.
0 of 150 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
- K032126: Promos Shoulder (2004), 130 descendants of its own
- K042021: Exactech Equinoxe Shoulder System (2004), 71 descendants of its own
- K063578: Promos Modular Shoulder System (2007), 67 descendants of its own
- K081016: Smith & Nephew, Inc., Promos Reverse Shoulder System (2008), 52 descendants of its own
- K110598: SMR Reverse Shoulder System (2011), 44 descendants of its own

Source page: https://510kreport.com/device/K010124
Methodology: https://510kreport.com/methodology